[SOLVED] BME 460 WUMC Regulatory and Manufacturing Car Practices Paper – Engineering

Standard Operating Procedure
Document #
10-RCM-001X
Print Date:
2/25/2020
Revision #
1.0
Date Prepared: 2/25/2020
Effective Date:
2/25/2020
Date Reviewed:
2/25/2020
Standard:
[Standard, Law, or Regulation]
Date Approved:
2/25/2020
1. Purpose and Scope:
1.1.
2. Safety and Environmental Precautions:
2.1.
3. Definitions:
3.1.
4. Procedure:
4.1. Check your owner’s manual
–
Locate physical book in the glove box, electronic versions online, or contact
your dealer
–
Look for maintenance schedule to find recommended time intervals of
maintenance items
4.2. Change your oil and oil filter
4.3. Change your air filter
4.4. Rotate Tires
4.5. Replace windshield wipers
4.6. Check your tire pressure and tread depth
10-RCM-001X Routine Car Maintenance 1.0
page 1 of 2
Standard Operating Procedure
4.7. Check other fluid levels (brake, transmission, coolant, washer)
4.8. Inspect belts and hoses
4.9. Inspect and check battery performance
4.10.
Wash and wax car
4.11.
Check function of lights (headlights, turn signals, brake, and parking)
4.12.
Professional inspections
5. Related Documents:
5.1.
6.
Revision History:
Revision
1.0
Date
Description of changes
Requested By
2/25/2020 Initial Release
7. Attachments:
10-RCM-001X Routine Car Maintenance 1.0
page 2 of 2
Standard Operating Procedure
Prof. Jack C. Chu
Purpose and Scope
This procedure defines the preparation, approval, authorization, control, revision, and management of all
Standard Operating Procedures (SOPs) and subset documents used in GMP regulated Manufacturing
Operations. This procedure is applicable to content authors, reviewers and approvers and Documentation
Management System (DMS) authors and stewards.
SOP Principles
1. The term SOP includes all written documents that provide directions or instructions for performing
required tasks in GMP operations and operational activities. The SOP shall include necessary
referenced documents as attachment, e.g., controlled forms, sterile supply equipment assembly
drawings, sterilization batch records and subset documents, etc.
2. Subset documents could be standard business practice (SBP), standardized work, and reference
document that may be developed where necessary as a subset of a governing SOP to provide
additional instruction for a specific task. Subset documents must align with their governing SOP.
3. Controlled forms may be used as paper documents or electronic templates and they shall have
the same core number as their governing SOP in DMS. Controlled forms are not required to have
all six sections mandated for SOPs; however, they must have a Change Control section. For
Controlled Forms without the six sections, the Change Control will be linked as a child document.
If the Content Author opts to keep one or more of the six sections, then a Change Control child
document is not required, provided the Change Control section is included as one of the six
sections.
4. SOP contents shall include the following sections:
a. Section 1 “Purpose and Scope”
The purpose of this SOP is to define the gowning, de-gowning, and personnel flow
procedures for Building 66 “Vaccine Manufacturing Facility”.
b. Section 2 “Safety and Environmental Precautions”
The following sanitizers are used for this SOP: 70% Sterile IPA Alcare or other approved
hand sanitizer II. Refer to SOP 15-QUE-217X Cleaning, Disinfection and
Decontamination of Classified Areas for the following: A. Approved products and
container types B. Expiration dates C. Safety precautions
c. Section 3 “Definitions”
• Controlled Locker Room: Locker room space provided to change into the Company
Issued, Blue lint-free uniform and dedicated safety shoes, which are required to enter
Classified Areas. Outside shoes should be covered prior to entry into the Controlled
Locker Room and remain covered within the Controlled Locker Room area. Personal
effects entering the Controlled Locker Room should be limited to street
clothing/scrubs and outside shoes. Additional personal items should be stored in
Personal Locker Room. Controlled Locker Rooms should not be used to transfer
material into classified areas or the Controlled Unclassified Corridor; reference SOP
24-ROT-602X for material transfer.
• Personal Locker Room: Locker room space provided for personal hygiene, showering
and storage of personal items. Make-up removal, prior to donning Blue lint-free
uniform and entering classified areas, should be performed in the Personal Locker
Room area.
d. Section 4 “Procedure”
•
Reference 24-QUE-365X (Grade C and D Gowning Procedure) for Pre-Gowning
Procedures.
• Reference SOP 24-MMR-106X (Use of Aseptic Techniques), 24-ROT-108 (Behavior
in Unidirectional Air Flow Hood), and 24-ROT-206 (Preparation and Use of Biological
Safety Cabinets) for general guidance on aseptic technique.
e. Section 5 “Related Documents”
▪ SOP 15-QUE-217X – Cleaning, Disinfection and Decontamination of Classified
Areas B.
▪ SOP 15-QUE-292X – Grade A/B Gowning Procedure
f. Section 6 “Change History”
• Section 4.1.D, added the requirement for shoes with green laces for all classified
areas to align with site SOPs 15-QUC-200X and 15-QUE-405X B.
• Section 4.II.A.3.a, added requirement to don safety glasses and hair/beard covers on
the first floor prior to movement to the 2nd floor processing areas.
g. Attachment
5. SOP numbers are issued and tracked by the Documentation Management System (DMS). All
SOPs may follow a numbering scheme similar to “10-QUA-001X”. For example:
a. The “10” references the most appropriate Quality Manual (QMS) chapter.
b. The “QUA” references the owning department, as per 10-QUA-R002.
c. The “001” is the next sequential number in the series.
d. The “X” indicates that the document is cross-referenced to at least one additional
department.
e. All Sterile Supply Equipment Assembly Drawings have a “DW” suffix
i. Example: 24-S28-001XDW
f. Controlled forms are numbered as follows:
i. Governing SOP Number, “F” Suffix, and the next sequential number
ii. Examples: 15-VAQ-123XF1
15-VAQ-123XF2
6. SOP titles shall be concise and define the content of the procedure.
7. An SOP that is updated due to a commitment or CAPA shall have a Commitment History
document attached. The DMS Author is responsible for creating/maintaining a Commitment
History Form in DMS in order to track the associated commitment history.
8. All SOP Content Authors shall use the current, approved template which is issued by the DMS
Author.
9. It is recommended that all SOPs are authored in MS Word. If any content resides in another
software package, the information or drawing may be inserted as an image or as an embedded
file.
10. As a repository system for all controlled documents, DMS system is used in parallel with the
training system. Therefore, consideration must be given to the effects on each system when
creating new or modifying existing documents and/or training requirements. Each system must be
aligned with the other and compliant with cGMP documentation and training requirements.
11. SOPs, paper based or electronic, shall be retained in accordance with Quality record retention
schedule.
12. SOP effective dates are 14 calendar days from DMS approval for all document types. Anything
less than 14 days is considered to be an early effective date.
13. Each SOP shall be reviewed and approved every three (3) years (minimal) based upon the
effective date of the current, effective version of the SOP. SOPs remain in effect until they are
superseded or inactivated.
14. All SOPs shall be reviewed and approved by, at a minimum, an area manager from the owning
department and a Quality representative. Review and approval function shall not be delegated to
a non-Merck employee.
15. The governing SOP shall be assessed and reviewed prior to updating any Controlled Forms
and/or Subset Documents to determine if updates need to be made to the governing SOP as a
result of the proposed changes. If assessment warrants an update to the governing SOP, the
effective date on the Controlled Forms and Subset Documents shall align with the effective date
on the governing SOP.
Requesting a Revision to an Existing SOP
Content Author
1. Formally request a Draft version of the SOP being revised from the DMS Author. Provide the
following information:
a. Document Number
b. Type of Update (Revision, Inactivation)
NOTE: If any change to the SOP is associated with a CR/CAPA/Commitment, the Content Author
must work with the CR/CAPA/Commitment owner for the timing of the changes.
NOTE: Some Controlled Forms will be in an editable PDF format and can be created as a draft.
Definitions
A. Child document – A Child Document is a related document to an SOP and is created/updated before
the related SOP is routed for DMS review (if requested) and approval. SOPs with child document(s) are
referred to as Parent documents in DMS.
B. Commitment History – The Commitment History is a Child Document and is a cumulative collection of
the commitments which affected the content of the parent document. If a commitment (CAPA, QCTS or
Regulatory Commitment) is a driver for any change to an SOP, that information must be recorded in a
Commitment History document maintained in DMS as a child document to the SOP.
C. Change Control Document – The Change Control Document is a Child Document and is created for
Controlled Forms when the Change History is not part of the Controlled Form.
D. Conceptual Approval – Document state prior to routing it for DMS approval. Document has
completed a Review outside of DMS, and all reviewers and eventual approvers have agreed to the
content.
E. Approver – The person who reviews/approves the SOP in DMS that Includes Business and Quality.
F. Content Author – The person responsible for updating the content of the procedure.
G. Documentation Management System (DMS) – An enterprise application providing electronic document
management. Documents are managed and reside within specific repositories in DMS.
H. DMS Author – The person responsible for processing the document and setting the document
properties in DMS. This role can be mapped to manufacturing areas or Quality.
I. DMS Steward – The person who enters the Planned Effective Date in DMS and creates/update the
SOPs training course in the training system. This role shall be mapped to Quality Assurance only.
J. Owning Department Representative – A representative from the department which owns the content
of the SOP. The owning department representative is a required approver in DMS.
K. Reference Documents – Documents that define, depict, or give meaning to something, such as the
Photo dictionary.
L. SOP Facilitator – A departmental representative who maintains and issues the working copies of the
SOPs for their department.
M. Standard Business Practice (SBP) – Written documents which define a standard approach to a nonGMP activity such as safety, environmental and financial topics (e.g. how to respond to a fire alarm, etc.)
N. Standard Operating Procedure (SOP) – Written procedure which provides specific directions for
performing certain operations that impact product identity, strength, quality or purity (e.g. cleaning,
gowning, sampling of environment, testing, and equipment operation). This excludes actual processing
records such as batch records.
O. Standardized Work – Tools to optimize a process, to drive variation out of a system, to diagnose
problems, & to be a catalyst for continuous process improvement. Standardized Work document are
diagnostic tools that help to drive continuous process improvements (e.g. Standardized Work Charts
(SWC) and Standardized Work Control Tables (SWCT))
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
I.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 1 of 35
Purpose and Scope
This procedure defines the preparation, approval, authorization, control, revision, and management of all Standard
Operating Procedures (SOPs), controlled forms/electronic logbooks (eLogs), and subset documents used in West
Point, PA. This procedure is applicable to content authors, reviewers, approvers and the Quality Assurance Center
of Excellence (CoE).
This procedure is written in alignment and conjunction with Quality Manual Guideline:
1. QS 1.30 QMS Operations/SOP Management
II.
Safety and Environmental Precautions
There are no potential safety or environmental concerns.
III.
Procedure
A. SOP Principles
1. Reference Attachment VI for SOP Process Flowchart at West Point.
2. The term SOP is used throughout this procedure, unless otherwise noted, it shall include the following:
a. Standard Operating Procedures (SOPs)
1) Sterile Supply Equipment Assembly Drawings
2) Sterilization Batch Records
3) Controlled Forms
4) Electronic Logs (eLogs)
b. Subset Documents – may be developed where necessary to provide additional instruction for a specific
task.
1) Standard Business Practice (SBPs)
2) Standardized Work
3) Reference Documents
Note: Only Standard Operating Procedures and Sterilization Batch Records are included in training curriculum and are
therefore included in the Training Determination Process (Attachments VIII and IX).
3. A SOP/ Subset Document effective date is (at a minimum) 14 calendar days from MIDAS approval for all
document types. Anything less than 14 days is considered to be an early effective date.
4. Controlled forms may be used as paper documents or electronic templates and must have the same core
number as their governing SOP in MIDAS. The only required sections are “Related Documents” and
“Change History,” located after the document’s content.
5. Electronic Logbooks (eLog) are utilized through the eShopFloor application. Each electronic logbook has a
governing SOP and controlled form with suffix “EL” in MIDAS and “eLog” in the title. Electronic Logbooks
are managed using Attachment VII (Electronic Logbook (eLog) Process Flow Chart).
Note:
For Laboratory Operations (LO) controlled forms, also follow SOP 22-LQA-315X. Laboratory Quality Assurance
manages change control and implementation of all LO Controlled Documents including Controlled Forms.
6. All SOP numbers are issued and tracked by the Quality Assurance CoE (SOP Unit). All SOPs follow a
numbering scheme similar to “10-QUA-001X”.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 2 of 35
a. The “10” references the most appropriate Quality Manual (QMS) chapter.
b. The “QUA” references the owning department, as per 10-QUA-R002.
c.
The “001” is the next sequential number in the series.
d. The “X” indicates the document is cross-referenced to at least one additional department.
e. All Sterile Supply Equipment Assembly Drawings have a “DW” suffix and pertain to QMS Chapter 16 –
Facilities and Equipment Design.

f.
Example: 16-S28-001XDW
Controlled forms are numbered as follows:

Governing SOP Number, “F” Suffix, and the next sequential number

Examples: 15-VQ2-123XF1
15-VQ2-123XF2
g. All electronic logbooks (eLogs) are numbered as follows:

Governing SOP/controlled form number, “EL” suffix, and the next sequential number (if applicable)

Examples: 24-SPM-329XEL1
24-SPM-329XEL2
7. SOP titles must be unique, concise and define the content of the procedure.
8. An SOP updated due to a commitment or CAPA must have a Commitment History document attached, as
well as documented in the SOP Change History section. Updates due to a CR must also be listed in the
Change History Section. The Quality Assurance CoE is responsible for creating/maintaining a Commitment
History Form (10-QUA-001XF3) in MIDAS in order to track the associated commitment history.
9. All SOP Content Authors must use the current approved template which is issued by the Quality Assurance
CoE. Content authors are expected to either be the SME or have access to SMEs to ensure accuracy of
the document content.
10. MMD global QMS procedures must be followed in their entirety as mandatory documents by internal MMD
sites and functions in scope of the procedure. Local SOPs are permitted in support of global QMS
procedures only when:
a. There are additional local or country-specific requirements or health authority recommendations that are
not included in the global QMS procedure.
b. There are product or site specific requirements that are not included in the global QMS procedure.
Note: If a local procedure is required to supplement the MMD global QMS procedure, it must identify and reference the
QMS document by its document ID (i.e. QS 1.30).
11. It is recommended all SOPs are authored in MS Word. If any content resides in another software package,
the information or drawing may be inserted as an image or as an embedded file within MS word.
12. As a repository system for all controlled documents, MIDAS is used in parallel with other validated systems.
Therefore, consideration must be given to the effects on each system when creating new or modifying
existing documents and/or training requirements. Each system must be aligned with the other and
compliant with cGMP documentation and other validated systems.
13. SOPs, paper based or electronic, must be retained in accordance with the MMD record retention schedule
at http://ts1.merck.com/com/ediscovery_records_management/Default.aspx.
14. Each SOP must be reviewed and approved every three (3) years (minimal). The Quality Assurance CoE
monitors SOPs to inform the business units when periodic reviews are coming due and tracks the updates
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 3 of 35
through to completion (Reference SOP 10-QUA-002X). SOPs remain in effect until they are superseded or
inactivated.
15. All SOPs must be reviewed and approved by, at a minimum,
1) the Content Author,
2) the owning department or system/subsystem owner (legacy QMS) or topic owner (new QMS)
3) and a Quality representative (see section B below).
Note: The reviewers/approvers listed above must be three different individuals.
4) Additionally, all eLogs must be reviewed using an approved electronic device (e.g. iPad) and
approved on the eShopFloor Web Interface website (https://elogbooks.merck.com/elogadmin/).
16. In instances where an SOP has been designated (MIDAS Properties) that it impacts multiple areas at the
site, the system/subsystem owner (legacy QMS) or Site Topic Owner (New QMS) must be an approver
(Author, Business or Quality). The system/subsystem owner has the responsibility to work with the
potentially affected areas at the site and gain alignment on the changes before approving on behalf of the
site.
17. When updating an SOP, the governing SOP and/or all subset/related documents must be assessed and
reviewed prior to updating to determine if updates need to be made as a result of the proposed changes. If
the assessment warrants an update to other documents, the effective dates must align.
18. If an SOP request is related to a Trackwise CR, the SOP should be approved prior to PET Quality
confirmation and have effective dates set after PET completion to align with SAP Valid from Dates. If an
SOP needs to become effective prior to PET, Quality confirmation rationale must be clearly defined in the
CR Execution Strategy.
19. For new or revised Logbooks, please refer to SOP 24-QUA-412X, Generating Maintaining, and Issuing
Logbooks in Grade A/B Spaces on the procedure.
1) For new and revised eLogs, both the MIDAS eLog form and the eShopFloor eLog form are created,
reviewed, and approved in a coordinated manner according to the business process outlined in
Attachment VII
B. Reviewing and Approving – West Point Quality
Note: Requirements for author and business approvers are detailed in Sections F and I below.
In accordance with regulatory requirements, West Point Quality is responsible for reviewing and approving written
procedures for production and process control designed to assure the drug products have the identity, strength,
quality and purity they purport or are represented to possess.
1. Read the SOP from beginning to end.
i. Review the title and Purpose and Scope statement and ensure they accurately reflect the subject
of the SOP.
1. Ensure the Purpose of the SOP is consistent with the content.
2. Assess the SOP Scope statement. This statement should be specific and clearly state
the operation(s), department(s), product(s), and/or process(es) included in the procedure.
ii. The Quality Approver is responsible for having an understanding of the subject matter. If you, the
Quality Approver, is unfamiliar with the subject matter, consult those who can provide additional
familiarity.
2. After you understand the purpose of the SOP, identify any applicable standards which may influence the
given procedure. Applicable standards may include, but are not limited to: regulatory requirements,
Merck policies, guidelines and standards.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 4 of 35
3. Ensure the SOP is logical and clearly written so an employee trained in cGMPs can easily understand
and follow the procedure to complete required duties.
4. Responsibilities must be clearly stated and address the following:
i. Actions / activity to be performed
ii. Individual function / department / person performing the specified action
iii. Order or sequence and timing of specified actions
iv. Manner or process in which specified actions are executed
v. Documentation required associated with specified actions
5. If the SOP is a revision, review the associated change control section to confirm and review the changes
made from the previous version.
6. Prior to approving an SOP, search the commitment database using key words or phrases, including the
SOP number, to ensure all commitments are included, if applicable.
i. If you do not have access to the commitment database, you can contact the coordinator of West
Point Commitment database to obtain access.
7. SOPs are often changed because of regulatory requirements. Ensure a change which seems logical
does not conflict with a previous regulatory commitment.
8. Review any attachments to ensure they are consistent with the written text in the SOP.
9. Ensure all cross-referenced SOPs exist and are within the approved expiry date.
10. The SOP should avoid use of ambiguous terms (such as ‘when necessary’).
11. Ensure all departments which have required actions review the SOP.
12. Ensure content owner and quality serve as approvers.
13. Ensure appropriate departments are cross-referenced.
14. Ensure the SOP is not cross-referenced to departments that have no action in the procedure, or no
specific need to routinely access the SOP. SOPs should be cross referenced to all West Point
departments only in rare cases.
15. Ensure terms which may not be universally understood are defined.
16. Make spelling and grammatical corrections as necessary.
17. Verify the MIDAS approvals have the correct Meaning of Signature
18. If the SOP meets the requirements of this procedure, approve the SOP, choosing Quality Approval as the
signature meaning. Your signature indicates you declare the SOP meets all the requirements of this
procedure. If the SOP cannot be approved, discuss problems/issues with the SOP content author.
i. In instances of West Point Quality approval for procedures outside of the MMD scope (i.e. Safety
Assessment and Laboratory Animal Resources); your signature indicates alignment with this
procedure on sections specific to the MMD departments only.
C. Business Continuity
1) In the event that the Shopfloor application is unavailable, please reference SOP 22-QUA-313X,
West Point eShopFloor SOP.
2) In the event that MIDAS is unavailable please contact the HelpDesk. If the MIDAS outage is
extended and has the potential to impact the business (safety or quality) please contact the Quality
Assuance CoE (SOP Unit) for assistance.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
STANDARD OPERATING PROCEDURE
Document Number:
10-QUA-001X
West Point, PA
Title: SOP Management
Version: 16.0
Author: Kim Fedele
Page: 5 of 35
o
If MIDAS is unavailable for an extended period of time, the Quality Assurance CoE will be
able to provide a printed copy of any SOP/subset document.
o
If during the MIDAS outage, there is a need to update an existing or create a new
SOP/subset document, the update and approval process will be managed outside of
MIDAS. The procedure will be updated (either via hardcopy or electronic copy if available)
and approvals will be captured via a wet signature. The Quality Assurance CoE will assign
an effective date (handwritten on the approved copy) and distribute to end users as
needed. Once the MIDAS system is restored an electronic copy will be uploaded into the
system with a new effective date; linking the paper copy as a child document.
D. Requesting MIDAS acess:
1. All SOP Content Authors must have a MIDAS general account and (at a minimum) a “Visitor” role in MMD
West Point Procedures. Contact the Help Desk for a MIDAS General account. To request a role within
the MMD West Point Procedures workgroup, click the following link to the MIDAS Workgroup Team
Access Request Form: https://collaboration.merck.com/sites/wpdoccenter/default.aspx and follow the
instructions on the form.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 6 of 35
E. Requesting a New SOP
Note: New SOPs do not require training track selection. Select “N/A” on the Training Determination Form.
1) Review the related corporate, divisional, site, area
and departmental documents to determine if the
existing documents can be used.
2) Consult the West Point Change Management
Procedure, 03-QUA-326X, to determine the
appropriate level of change.
3) If a new number is needed (SOP and Sterilization
Batch Record only), request authorization from the
SSO via email. Attach approval and formally
request a new number and the current template
from the Quality Assurance CoE (SOP Unit).
Provide the following information:
a) Reason for new SOP
b) Type of Document (SOP, eLog, SBP, etc.)
c) Docuemnt Title
d) QMS Chapter
e) Owner department’s 3-digit code
(Reference 10-QUA-R002)
f) Functional Group (Reference Attachment
I, Table 2A.
g) Cross-referenced departments (yes or no)
h) Will this SOP need SSO approval for future
updates (Yes/No):
Note: SOPs changing owning departments will not
require SSO approval to generate new SOP number
Note: If converting a Controlled Form to eLog, ensure
all impacted departments utilize the Shopfloor App;
otherwise, redirecting Controlled Form is not an option
and will need to remain as needed.
4) Prior to issuing new number, confirm SSO
approval, perform an audit of the master list in
MIDAS and the master spreadsheet to ensure no
duplicate documents exist in the electronic
system.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
F.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 7 of 35
Requesting a Revision to an Existing Document
Note:
If an SOP request is related to a Trackwise CR, the SOP should be approved prior to PET Quality
confirmation and have effective dates set after PET completion to align with SAP Valid from Dates. If
an SOP needs to become effective prior to PET, Quality confirmation rationale must be clearly defined
in the CR Execution Strategy.
Note:
For new and revised eLogs, both the MIDAS eLog form and the eShopFloor eLog form are created, reviewed
and approved in a coordinated manner according to the business process outlined in Attachment VII. It is
recommended the business process flow in Attachment VII be utilized as a visual guide when processing
eLogs according to the following procedures.
1) Formally request a draft version of the SOP
from the Quality Assurance CoE. Include the
following information in the request.
a) Document number
b) Type of update (Revision or
Inactivation)
Note: All Content Authors must have a MIDAS
General account and (at minimum) a “Visitor” role
in MMD West Point Procedures.
Note: if the need to transfer ownership of an SOP
arises, the current author must send a notification
to the SOP Unit, who will then confirm MIDAS
access. The new author must be copied on this
communication.
Note: If any change to the SOP is associated
with a CR, the Content Author must work with the
Change Owner for the timing of the changes and
identify/ include them in the draft request.
Note: If any change to the SOP is associated
with a CAPA/Commitment, the Content Author
must work with the CAPA/Commitment owner for
the timing of the changes.
2) Create a draft of the document.
Note: Drafts can only be created if the latest
version is “Effective.”
3) Add a “Draft” watermark to the document.
4) Activate track changes and increase the
version number matching MIDAS in the
header to align with the MIDAS version.
5) Save the MIDAS pdf version of the
Commitment History document (if applicable).
6) Send the Word version of the draft SOP to the
Content Author and include:
a) Document Request Form (10-QUA001XF7)
b) PDF version of the Committment
History Form (if applicable).
Note: If an editable Controlled Form and Word
version is not available, send the pdf version of
the draft SOP. Insert a comment to the Content
Author to increase the version number by one and
change the Author as appropriate.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 8 of 35
G. Creating / Revising the Document
1) Ensure content aligns with all
applicable GMP regulations &
Merck standards.
2) Verify cross-referenced
departments (See Attachment V)
3) Edit and review the procedure for
clarity, accuracy and ease of use.
4) Consider the impact of the
changes and align with any other
related documents such as Batch
Records, Quality Standards and
Quality Manual Documents.
Note: If Controlled Form or eLog
version needs to be created, request
a new number from Quality
Assurance CoE (SOP Unit).
5) For SOPs being inactivated or
redirected to another procedure,
replace all instructions with a
one-line statement (i.e. the
revised document is one page)
explaining the change and, as
appropriate, specifying a new
location of the contents. For
example:
 Redirect: “The content of
SOP [number] is found in
SOP [number].”
 Inactivation: “SOP [number]
was inactivated because
[include justification].”
6)
Ensure all related SOPs and
Controlled Forms/eLogs are
aligned and reference the
governing SOP.
7) Capture all changes in the
Change History section of the
SOP. Use the following
guidance:
a) Indicate “New
Document” for new
SOPs
b) For revisions, remove
previous change history
information. Only
current changes should
be listed.
c) If a new SOP number is
assigned or a new
template is used, list the
previous document
number. Example:
Transferred content
from SOP [number].
d) Complete
Common/Routine
Update(s) section.
Reference any
applicable change
drivers such as
regulatory
Commitments, CAPAs
or Change Requests.
e) Complete Change
Details section. Use
action verbs at the
beginning of each
statement (i.e. added,
updated, deleted,
changed, replaced,
etc.).
8) Complete the Training
Determination Form for revised
documents. Reference Attachment
VII for the Training Decision Tree
and Attachment IX for Definitions.
Document which level of training
required:
a) Level 1: – No training
required (waiver).
Reference 11-T&D-002X:
SOP Training Waiver
Process. Rationale for no
training required must be
documented on the Training
Determination Form.
b) Level 2: Training Required:
Read and Acknowledge the
Change History. Develop
supplemental training deck.
Template located on the
WP MMD Document Center
TeamSite.
c) Level 3: Training Required:
Expanded SOP with
Knowledge Check. Develop
supplemental training deck
amd Knowledge Check
deck. Templates located on
the WP MMD Document
Center TeamSite.
d) Level 4: Training
Intervention Required:
Contact your local learning
specialist, or LSS if not
supported by a local
learning specialist to
perform a Learning Needs
Analysis.
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Document Number:
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Version: 16.0
STANDARD OPERATING PROCEDURE
Title: SOP Management
Author: Kim Fedele
9) Identify the required approvers.



West Point, PA
Content author
Business Owner,
System/Sub-System
owner
Quality approver
10) Confirm all approvers (including
the content author)have the
appropriate approval access in
MIDAS and the eShopFloor
Interface website.
a) Content authors need
(at a minimum)
“Visitor” access in
MMD West Point
Procedures
workgroup.
b) MIDAS Business
approvers need “Area
Management” access
in MMD West Point
Procedures
workgroup team.
c) MIDAS Quality
approvers need “QA:
GMP” access in MMD
West Point
Procedures
workgroup team.
11) eLog approvers need to
complete required training
and request access to
eShopFloor Web Interface.
12) eLog SOPs must have the
same approvers in both
MIDAS and the eShopFloor
Web Interface website;
however, the Content Author
is excluded from the
ShopFloor app e-Log
approval process. The
Content Author reviews the
MIDAS version only.
Page: 9 of 35
13) Consult with Learning and
Development prior to SOP
approval to identify an
appropriate curriculum for a
new SOP.
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STANDARD OPERATING PROCEDURE
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Author: Kim Fedele
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H. Approving a New / Revised Document
1) Verify Version Number, Title,
Author Name, and Page
Numbers are correct on all
pages.
2) Verify the content is on the
appropriate template with the six
required sections (if applicable)
and the document is formatted
correctly.
Note: If a revision is related to a
Commitment, the SOP Unit updates
the Commitment History form (10QUA-001XF3)
3) All changes should be accepted
and all comments deleted. The
version should be clean and track
changes turned off.
4) For a Controlled Form (e.g. F1,
F2, EL1, EL2) or Drawing SOP,
ensure Related Documents and
Change History sections are
included, accurate and reflect
current changes.
5) If redirecting an SOP to a new
SOP, include the one-line redirect
SOP.
6) When the document and
supplemental training decks are
conceptually approved offline
and ready for approval, email
the Quality Assurance CoE
(SOP Unit) with the following:
a) Conceptually approved
document
b) Completed Document
Request Form (10QUA-001XF7)
c) If Track 2 or 3 training
determination was
selected include the
supplemental training
deck(s).
Note: Once confirmation is
received SOP has been launched
for MIDAS approval, delete all
copies saved on your computer,
shared drive, Teamspace, etc. This
ensures if changes are required,
the most recent version is utilized.
7) Upload the conceptually
approved document to
MIDAS (REF 10-QUA-R006).
a) Remove the “Draft”
watermark
b) If any commitments
or CAPAs are related
to the update,
create/update and
approve the SOP’s
Commitment History
document (10-QUA001XF3) in MIDAS.
c) For Track 2/Track 3
Training, upload/
update in MIDAS.
d) Update and verify
MIDAS properties.
e) Review pdf rendition.
f) Initiate SOP for
MIDAS approval
(REF 10-QUA-R006)
and notify Content
Author the SOP is out
for approval.
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Version: 16.0
STANDARD OPERATING PROCEDURE
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Author: Kim Fedele
Page: 11 of 35
Note: Access the document for approval through either the e-mail notification from MIDAS
(DM Administrator@merck.com) or your MIDAS Inbox.
8) The Content Author receives the
approval task first and formally
reviews the document to ensure
accuracy.
9) Review document for any
formatting issues (including
ensuring “Draft” watermark is
removed, headers, footers, page
numbering, page breaks,
appropriate sensitivity label, etc.).
10) If any commitments or CAPAs
are related to the update, review
the SOP’s Commitment History
document (10-QUA-001XF3) in
MIDAS
11) If content is satisfactory, select
the following “Signature
Meaning”. Signature meanings
are part of the official record. An
individual may have only one
signature meaning.
a) MEANING: AUTHOR
b) OUTCOME: APPROVE
Note: Selecting any other meaning
than “Author” will require the SOP
to be rerouted for approval.
12) Enter ISID and network password
to complete approval process.
Note: If at any step,
13) All business approvers receive this task
simultaneously after the Content Author
reviews the SOP in MIDAS The Quality
representative receives the Approval
task after all business approvers have
approved.
14) MIDAS Delegates are able to act on
behalf of the originally selected
Approvers.
15) All approvers must:
a) Confirm the “For Approval”
version aligns with the
conceptually approved
document.
b) Verify the properties in MIDAS
are correct (Attachment I).
c) Review document for any
formatting issues (including
ensuring “Draft” watermark is
removed headers, footers, page
numbering, page breaks,
appropriate sensitivity label,
etc.).
16) If content is satisfactory, approvers must
select the applicable “Approval,
Authorization” for their role. Signature
meanings are part of the official record.
An individual may have only one
signature meaning.
a) MEANING: APPROVAL,
AUTHORIZATION
b) OUTCOME: APPROVE
17) Enter ISID and network password to
complete approval process.
18) If content is satisfactory,
Quality Approver selects
“Quality Approval.” Approval
confirms the requirements
listed under the business
approver are met and the
document complies with all
applicable regulations and
company policies, and is
approved for use. There is
only one Quality approver per
document.
a) MEANING:
QUALITY
APPROVAL
b) OUTCOME:
APPROVE
Note: Selecting any other
meaning than “Quality
Approval” will require the SOP
to be rerouted for approval.
19) Enter ISID and network
password to complete approval
process.
additional changes are required,
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
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Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 12 of 35
select “Reject.” The Quality Assurance CoE will receive a rejection notification and notify the content author.
The content author will make any required changes and send back to the Quality Assurance CoE to upload and
launch for approval.
I.
Post Approval of a Document
1) If the approved document is NOT
associated with a TrackWise CR, enter the
requested planned effective date.
2) If the approved SOP is associated with a
TrackWise CR, contact the Content Author
and Change Owner for Trackwise
confirmation and the requested planned
effective date.
3) Contact the CR Change Owner requesting
the following information:
a) Confirmation the CR is in the
appropriate stage gate for the
document to go effective via
Trackwise confirmation page or screen
shot.
b) Requested planned effective date.
Note: SOPs which are CR-related and list
Trackwise state as “Awaiting PET Completion”
cannot receive a planned effective date unless
Quality confirmation rationale is clearly defined
in the CR execution stratgey. For additional
information, contact a Quality Assurance
Change Analyst for assistance.
4) Notify the Quality Assurance CoE (SOP
Unit) with the information above.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
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Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
5) Enter the planned effective date in
MIDAS.
Note: If a requested effective date falls
before 14 days (or an off-cycle date) postapproval, authorization for an early effective
date is required
6) Update/create training course in the
learning management system for new
and Track 1 SOPs.
a) If Track 1 if selected on the Training
Determination Form, process waiver
in the learning management system.
Reference SOP 11-T&D-002X SOP
Training Waiver Process.
b) If Track 2, Track 3 or Track 4 is
selected, create a request to the
Learning Shared Services (LSS) for
SOP’s training.
7) Email the Content Author and (if
necessary) ShopFloor Designate and/or
CR Owner confirming MIDAS and the
learning management system are
updated, along with the planned effective
date.
Page: 13 of 35
8) Ensure all SOP related communications
are cascaded appropriately.
9) For a new SOP or an early effective date,
SOP Author is to include impacted SOP
Facilitator(s) and Learning Specialist(s).
10) Follow directions in SOP 10-QUA-002X.
11) The facilitators must also utilize the SOP
Facilitator Tracking and Reconciliation
Form (SOP 10-QUA-003X) in order to
record the issuance and destruction of
each SOP and maintain an accurate
accountability of the issued “hard copies”.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
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Version: 16.0
J.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 14 of 35
Inactivating a Document
1) Review the SOP targeted
for inactivation and identify
all procedures crossreferenced or linked to it.
a) If a gap is created by
inactivating the
targeted SOP, address
the gap by updating
those linked
procedures. Be sure to
align planned effective
dates of revised and
inactivated documents.
2) Follow the previous
sections to revise, review,
approve and set the
planned effective date of
the inactivated SOP.
3) Consult with
Management to
determine the training
impact.
4) Determine which
departments and job
functions currently use
the procedure targeted
for inactivation.
5) Assess the training
impact and consider the
following:
a) Training plans should
be reviewed for
redundant
procedures which
were inactivated.
6) When the 3-year review
date is reached for the
inactivated SOP, the
SOP is deleted in
MIDAS.
7) Procedures
inactivated due to
discontinued
processes should be
inactivated from
Training System.
Note: When a
document is inactivated,
the number should not
be re-used in the future.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
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Version: 16.0
K.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 15 of 35
eLog Development and Approval
7) Create/Revise the eLog
content via draft request to
the Quality Assurance CoE.
The content in the
controlled “EL” form in
MIDAS must match the
information in the eLog
version.
8) For new eLogs, send an
email to the Quality
Assurance CoE (SOP Unit)
with the following
information:
a) Title: (must include the
word “eLog”)
b) Parent SOP #
c) Owning Department
Code
d) QMS Category
e) Functional Group
f) Cross-Referenced
departments (Yes/No)
g) Orientation (Landscape
or Portrait)
Note: If any change to the
SOP is associated with a
CAPA/Commitment, the
Content Author must work
with the CAPA/Commitment
owner for the timing of the
changes.
6) Provide draft/template to
content author
Note: The eShopFloor
application contains electronic
control measures for GMP
documentation. To provide
the same suitable control
measures for GMP
documentation within the
SOP/controlled “EL” form in
MIDAS, additional information
was added to the template
(e.g. “Reviewed By”) that does
not affect the content of the
eLog.
1) Include version number
and eLog ID in Change
History.
2) The content in the eLog
can be changed only when
the eLog is in the draft
version.
3) Since the six core sections
are not included in the
content, eLogs must
include 2 core sections –
Related Documents and
Change History, which is
located on the last page.
4) Include the same
approvers for the eLog as
the controlled “EL” form in
MIDAS.
5) Save the eLog form as a
draft version.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
16) Review the created eLog
form on an approved
electronic device to ensure
content is accurate.
17) The approvers must
conceptually review both
the parent SOP/Controlled
“EL” Form and the eLog
form at the same time.
a) To view eLog drafts on
approved electronic
device, set the
eShopFloor application
location to “eLog
Unapproved Forms.”
18) Comments/changes to the
eLog form must be
communicated to the
content author during the
SOP review. Address
comments and finalize
eLog form.
9) Verify Version Number, Title, Author
Name, and Page Numbers are correct
on all pages.
10) Verify the content is on the appropriate
template and ensure Related
Documents and Change History
sections are included, accurate and
reflect current changes.
11) Verify (if applicable) the CAPA,
Commitment, and/or CR information is
captured in the Change History section.
Note: If a revision is related to a
Commitment, the SOP Unit updates the
Commitment History form (10-QUA001XF3).
12) All changes should be accepted and all
comments deleted. The version should
be clean and track changes are turned
off.
13) If redirecting an SOP to a new SOP,
include the one-line redirect SOP.
14) When the document is conceptually
approved offline and ready for approval,
email the Quality Assurance CoE (SOP
Unit) with the following:
a) Conceptually approved document.
b) Completed Document Request
Form (10-QUA-001XF7)
Note: Once confirmation is received SOP
has been launched for MIDAS approval,
delete all copies saved on your computer,
shared drive, Teamspace, etc. This
ensures if changes are required, the most
recent version is utilized.
Page: 16 of 35
15) Route eLog for approval in
MIDAS.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
25) The Content Author receives the
MIDAS approval task first and
formally reviews the document to
ensure accuracy.
26) Review document for any
formatting issues (including
headers, footers, page numbering,
page breaks, appropriate
sensitivity label, etc.).
27) If any commitments or CAPAs are
related to the update, review the
SOP’s Commitment History
document (10-QUA-001XF3) in
MIDAS.
28) If content is satisfactory, select the
following “Signature Meaning”.
Signature meanings are part of
the official record. An individual
may have only one signature
meaning.
a) MEANING: AUTHOR
b) OUTCOME: APPROVE
Note: Selecting any other meaning
than “Author” will require the SOP to
be rerouted for approval.
29) Enter ISID and network password
to complete review process.
30) All business approvers receive
this task simultaneously after the
Content Author reviews the SOP
in MIDAS The Quality
representative receives the
Approval task after all business
approvers have approved.
21) MIDAS Delegates are able to act
on behalf of the originally selected
Approvers.
22) All approvers must:
a) Confirm the “For Approval”
version aligns with the
conceptually approved
document.
b) Verify the properties in MIDAS
are correct (Attachment I).
c) Review document for any
formatting issues (including
headers, footers, page
numbering, page breaks,
appropriate sensitivity label,
etc.).
d) If approval criteria are met,
select “Approve” in MIDAS.
23) If content is satisfactory, approvers
must select the applicable
“Approval, Authorization” for their
role. Signature meanings are part
of the official record. An individual
may have only one signature
meaning.
a) MEANING: APPROVAL,
AUTHORIZATION
b) OUTCOME: APPROVE
24) Enter ISID and network password
to complete review process.
Page: 17 of 35
19) If content is satisfactory,
Quality Approver selects
“Quality Approval.”
Approval confirms the
requirements listed under
the business approver are
met and the document
complies with all applicable
regulations and company
policies, and is approved
for use. There is only one
Quality approver per
document.
Note: Selecting any other
meaning than “Quality
Approval” will require the
SOP to be rerouted for
approval.
20) Enter ISID and network
password to complete
review process.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
35) When all Approvals
are completed with
an “Approve”
outcome, the
document achieves a
MIDAS state of
“Approved.”.
31) Approve the eLog
form in the
eShopFloor Web
Interface website.
32) Forward SOP Unit
eShopFloor approval
notification
Note: All approvers
receive the review and
approval task
simultaneously.
Page: 18 of 35
33) Assign planned
effective date in
eShopFloor to align
with MIDAS effective
date.
34) Communicate
effective date to
Author
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10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 19 of 35
L. eLog Inactivation
4) Review the controlled 3) Follow the
“EL” form and eLog
Inactivating a
form targeted for
Document section to
inactivation and
inactivate the
identify all
controlled “EL” form
procedures crossin MIDAS through the
referenced or linked
approval process.
to it. Remove any
references to
inactivated controlled
“EL” form and eLogs
from the parent SOP.
a) If a gap is
created by
inactivating the
targeted SOP,
address the gap
by updating those
linked
procedures. Be
sure to align
planned effective
dates of revised
and inactivated
documents.
5) Follow the eLog
development and
approval process to
review, approve and
set the planned
effective date of the
inactivated controlled
“EL” form.
2) The eLog forms must
to be archived using
the eShopFloor Web
interface website.
Match the effective
date of the
inactivated controlled
“EL” form with the
archive date of the
eLog.
Note: The timing for the
archive must be set to
12:01 AM on the day the
controlled “EL” form is
made effective for
deletion.
1) When the 3-year
review date is
reached for the
inactivated SOP,
inactivate by
changing status to
inactive.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
IV.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 20 of 35
Related Documents
A. QS 1.30 QMS Operations/SOP Management
B. 03-QUA-326X West Point Change Management Procedure
C. 10-QUA-002X Administering, Issuing, and Facilitating Site Documentation
D. 10-QUA-003X SOP Facilitator and Reconciliation Form
E. 10-QUA-001XF1 SOP Template
F. 10-QUA-001XF2 Reference Document Template
G. 10-QUA-001XF3 Commitment History Template
H. 10-QUA-001XF4 Standardized Work Template
I.
10-QUA-001XF7 Document Request Form
J.
10-QUA-001XF8 Sterilization Batch Record Template
K. 10-QUA-001XF9 Standard Business Practice Template
L. 10-QUA-001XF10 SOP Template for Controlled Forms and Drawings
M. 22-QUA-313X West Point eShopFloor SOP
N. 22-LAB-315X – Laboratory Operations Controlled Testing Document Revision
O. 24-QUA-412X Generating Maintaining, and Issuing Logbooks in Grade A/B Spaces
P. 24-QUA-412XEL1 Portrait eLog Template
Q. 24-QUA-412EL2 Landscape eLog Template
R. 11-T&D-002X: SOP Training Waiver Process
S. 10-QUA-R001 SOP Numbering
T. 10-QUA-R002 SOP Departmental Codes
U. 10-QUA-R006 “Management of SOPs for MIDAS Stewards
V. eShopFloor-SA-001 – eShopFloor System Access SOP (DOCUMENT GS-MMDIT-399)
W. eShopFloor-UG-002 – eShopFloor Mobile App (DOCUMENT GS-MMDIT-397)
X. eShopFloor- UG-003 – eShopFoor Web Interface SOP (DOCUMENT GS-MMDIT-398)
Y. 22-QUA-127X West Point MMD GMP Documentation Requirements
V.
Definitions
Term
Description
Approver
The person who approves the SOP in MIDAS. Includes Area Management and
Quality.
Business Approver
A representative from the owning department or QMS System/Subsystem owner
which owns the content of the SOP. This is a required approver in MIDAS.
Child Document
A related document to an SOP and is created/updated/approved before the related
SOP is routed for MIDAS approval. SOPs with a child document are referred to as
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Term
Page: 21 of 35
Description
Parent documents in MIDAS.
Commitment History
A cumulative collection of the commitments which affected the content of the parent
document. If a commitment (CAPA, QCTS or Regulatory Commitment) is a driver for
any change to an SOP, this information must be recorded in a Commitment History
document maintained in MIDAS as a child document to the SOP.
Conceptual Approval
Document state prior to routing it for MIDAS approval. Document has completed a
review outside of MIDAS, and all reviewers and eventual approvers have agreed to
the content.
Content Author
The person responsible for updating the content of the procedure.
eLog
A module which allows users to fill out & submit electronic logs (eLog) from the iPad in
online/offline mode. The application also allows the users to view the submitted logs in
online mode. This application is supported by an admin web app, which allows
creation or editing of the forms that can be viewed on the iPad and generating reports
on submitted logs. Users are required to authenticate with their network ISID and
Password when submitting or approving logs and forms. All data is stored in a GMP
validated oracle database.
eShopFloor Web
Interface
A web based tool for admin users and must use google chrome to view content. Using
this tool, admin can create/edit forms and assign the forms to specific locations.
These forms are used for eLog creation using the eShopFloor iPad application.
MIDAS
Quality Assurance
CoE
(Merck Integrated Document Architecture and Services) An enterprise application
providing electronic document management. Documents are managed and reside
within specific repositories in MIDAS. West Point SOPs are located in MIDAS R&D
(MMD West Point Procedures).
The group which has a reporting structure outside the E2E system and is responsible
for processing content in MIDAS and the training system. This role shall be mapped to
Quality Assurance only (SOP Unit).
Reference Documents
Documents which define, depict, or give meaning to something, such as the Photo
dictionary.
SOP Facilitator
A departmental representative who maintains and issues the working copies of the
SOPs for their department.
Standard Business
Practice (SBP)
Written documents which define a standard approach to a non-GMP activity such as
safety, environmental and financial topics (e.g. how to respond to a fire alarm, etc.)
Standard Operating
Procedure (SOP)
Written procedure which provides specific directions for performing certain operations
that impact product identity, strength, quality or purity (e.g. cleaning, gowning,
sampling of environment, testing, and equipment operation). This excludes actual
processing records such as batch records.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 22 of 35
Term
Description
Standardized Work
Tools to optimize a process, to drive variation out of a system, to diagnose problems,
& to be a catalyst for continuous process improvement. Standardized Work document
are diagnostic tools that help to drive continuous process improvements [e.g.
Standardized Work Charts (SWC) and Standardized Work Control Tables (SWCT)].
Supplemental Training
Deck
Slide deck providing additional, more detailed information for the change(s) made for
a revision.
Training Determination
Form
Form to document the level of training required for a revision
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
VI.
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 23 of 35
Change History
☐ New Procedure
☒ Revised Procedure
1. Reason for Update (check all that apply, if any)
☐ 3-Year Review
☐ Commitment #
☐ Internal/Divisional Audit
☐ Shop Floor Observation
☐ Safety Incident
☒ Process Improvement/Clarification
☐ Change Request #
☐ Other:
2. Common/Routine Update(s): (check all that apply, if any)
☒ Minor Grammatical Updates
☒ Rewritten for clarity
☐ Formatting Changes
☐ Terminology Changes
☐ Updated owning department /Author Name
3. Change Details
A. Updated requirements for designated SOPs requiring SSO approval. Approval can now be under Author,
Business or Quality Role.
B. Updated Teamspace link throughout
C. Updated new SOP number issuance to include SSO approval.
D. Removed requirement for SOPs whose owning department changes to obtain SSO Approval prior to
receiving new SOP number
E. Adjusted requirement for Content Author or eShopFloor designate to forward eShopFloor approval
notification rather than eShopFloor screenshots to SOP Unit.
F. Changed ownership of applying planned effectives in eShopFloor date to SOP Unit
G. Updated Training Determination form to include New SOP option and clarified Track 2 supporting
documentation.
H. Added note to clarify if a local procedure is required to supplement the MMD global QMS procedure, it
must identify and reference the QMS document by its document ID (i.e. QS 1.30).
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 24 of 35
Training Determination: Select one level of training below.
☐
N/A
New SOP
No Training Required (Waiver). Select the reason:
☐ 3-Year Review, no content change
☐
Track 1
☐ Format/grammar changes. Header correction (ex: author /version, page #, and title)
☐ Department Number Only / QMS Category
☐ De-coupling of Attachment(s) from SOP
☐ Other
Rationale for no training (required to be completed):
Training Required. Read and Acknowledge the Change History document.
☒
Track 2
Proceed to MMD WP Doc Center Teamsite: SOP Training Process Folder and access Template to complete.
Training Required: Expanded SOP with Knowledge Check.
☐
Track 3
Proceed to MMD WP Doc Center Teamsite: SOP Training Process Folder and access Template to complete.
Training Required: Instructor-Led/Hands-On Training.
☐
Do current training materials need to be updated (Reference SOP 11-T&D-011X)?
☐ Yes
☐ No
Track 4
Do training materials need to be made available in myLearning as a new learning course?
☐ Yes
☐ No
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 25 of 35
Attachment I: MIDAS Properties
Table 1:
Document Type and Subtype
Table 2A:
SOPs, Standardized Work, Standard Business Practices, Reference Documents
Table 3:
Child Documents
Table 1: MIDAS Properties for
Document Type and Subtype
For fields not listed, keep the MIDAS default value (even if blank).
Table 1A: SOPs, Standardized Work, Standard Business Practices, Reference Documents
Repository
MIDAS R&D
Document Type
“Policy-SOP-Standard”
Document Subtype
“Standard Operating Procedure”
Table 1B: Child Documents
Repository
MIDAS R&D
Document Type
“Policy-SOP-Standard”
Document Subtype
“Supporting Documentation”
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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STANDARD OPERATING PROCEDURE
Document Number:
10-QUA-001X
West Point, PA
Title: SOP Management
Version: 16.0
Author: Kim Fedele
Page: 26 of 35
Table 2A: MIDAS Properties for
SOPs, Standardized Work, Standard Business Practices, Reference Documents
For fields not listed, keep the MIDAS default value (even if blank).
Tab
General
Property
Document Name
(Character Limit = 256)
General
Classification
Value
< Document number + Smart Title >
SOP example: 10-QUA-123X Sample SOP Title
Author as Person
< Content Author’s Name(s) >
Applicability
“Division”
Business Area
“Manufacturing”
Division Abbreviation
“MMD”
Organization Unit
< 3 digit alpha-numeric department code of Owning Department >
(REF 10-QUA-R002)
Workgroup Team
“MMD West Point Procedures”
Merck Site
“WEST POINT, PA PLANT”
Document Type
“Policy-SOP-Standard”
Document Subtype
“Standard Operating Procedure”
Document Unit
Retention Class
“Official”
Sensitivity Class
“Proprietary”
Comments
Choose appropriate option (if applicable):
“Redirect Statement” or “INACTIVE”
Enter Track #
Periodic
Review
Periodic Review
Interval
“3 years”
SOP/SOG
SOP ID
SOP Organization
Use Cross Reference
< 3 digit alpha-numeric department code of Content Owner and any cross-referenced departments > (REF 10-QUA-R002)
Note: Type in as “New Item” in Selection Box.
QMS Category
< Select the appropriate QMS Category from the drop-down list. >
Functional Group
< Select from the following: A&IT, Engineering, Environment, Facilities, Finance, Human Resources, Laboratory, Maintenance, Manufacturing, Packaging, Planning, Plant Administration, Procurement, Quality Assurance, Quality Operations, Safety/Environment, Technical Operations, Training, Warehouse >
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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STANDARD OPERATING PROCEDURE
Document Number:
10-QUA-001X
West Point, PA
Title: SOP Management
Version: 16.0
Author: Kim Fedele
Page: 27 of 35
Table 3: MIDAS Properties for Child Documents
For fields not listed, keep the MIDAS default value (even if blank)
Tab
Property
Value
General
Document Name
Child Document:
[SOP Number] [Document Type]
(Character Limit = 256)
CH: Commitment History e.g. 10-QUA-001 CH
Author as Person
CH: < Quality Assurance CoE Admin >
Applicability
“Division”
Business Area
“Manufacturing”
Division Abbreviation
“MMD”
Organization Unit
< 3 digit alpha-numeric department code of Content Owner >
You will need to add department as “New Item” since MIDAS doesn’t
recognize our departments
Note: Refer to 10-QUA-R002 if needed
Classification
Workgroup Team
“MMD West Point Procedures”
Merck Site
“WEST POINT, PA PLANT”
Document Type
“Policy-SOP-Standard”
Document Subtype
“Supporting Documentation”
Retention Class
“Official”
Sensitivity Class
“Proprietary”
Country
“United States”
Comments
Track # if applicable
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 28 of 35
Attachment II: Additional Guidance for Selecting Approvers
ENVIRONMENTAL MONITORING approves documents which include:

Housekeeping (cleaning/disinfection) for classified areas
INFORMATION TECHNOLOGY (IT) CLIENT SERVICES approves documents which include:

Operations SOPs which are automation related or have automation content
SAFETY & ENVIRONMENT approves documents which include updates affecting:

Handling/storage/use of chemicals and compressed gases

Personal protective equipment

Bulk movement of materials (e.g. ergonomic controls)

Access to hazardous environments (e.g. posted areas, high noise, heat, cold, confined space, etc.)

Safety captions

Loss control

Emergency procedures

Passive and active safety controls (e.g. interlocks, alarms, e-stops, instruments, PRD, guards, ventilation, ergonomic
controls)

Emissions from chemical used in processing such as alcohol

Pollution prevention control (e.g., wastewater neutralization, biological inactivation/disinfection, process VOC control,
oxidizers/scrubbers)

Tank and vent systems

Cleaning procedures (e.g. volume of cleaners, disinfectants used)

Potable water systems connections

Waste storage, generation, treatment
TECHNOLOGY approves documents which include:

New documents that contain validated methods/equipment/systems

New documents that contain cleaning, sterilization, depyrogenation, lyophilization procedures

Changes to validated methods / equipment / systems

Changes to validated cleaning, sterilization, depyrogenation, lyophilization procedures

All production methods or manufacturing equipment operating procedures

SIP/CIP or process related cleaning

The use of reagents, chemicals, etc. utilized in manufacturing
QUALITY approves all SOPs and Subset Documents
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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STANDARD OPERATING PROCEDURE
Document Number:
10-QUA-001X
West Point, PA
Title: SOP Management
Version: 16.0
Author: Kim Fedele
Page: 29 of 35
Attachment III: Approval of SOPs if MIDAS is non-functional
Responsible Party
Action
Content Author
1. Contact Quality Assurance CoE (SOP Unit) for assistance if a document must be
created or revised during a time period when MIDAS is non-functional.
2. Instruct the content author to assemble the new SOP or modify an existing
procedure depending on the circumstances.
3. Review the document offline (i.e. outside of MIDAS) and resolve all comments.
4. Approve the documents via wet signatures.
Quality Assurance CoE
5. Migrate the document into MIDAS after functionality returns by importing a
scanned copy of the document.
6. Notify MIDAS Steward to enter the Planned Effective Date prior to routing. Align
the effective date with the wet signature version.
7. Send the scanned document for approval to the initiator’s manager using the
“Management Approval Workflow”.
8. A memo to file must also be included and retained with the wet signature
document explaining the reason for the scanned version.
Approver
9. The approver must use the “Imported or migrated copy” signature meaning.
10. The wet signatures will be maintained and archived by the MIDAS Steward.
Quality Assurance CoE
11. Enter the Planned Effective Date prior to routing. Align the effective date with the
wet signature version.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
a
Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 30 of 35
Attachment IV: Viewing SOPs in MIDAS
When you retrieve an SOP in MIDAS, make sure you ALWAYS highlight the SOP and “View”, “Versions” to ensure you’re
pulling the LATEST version.
Please take note of the following icons to the left of the number:

If this icon to the left of your SOP, you can simply double-click the SOP and the pdf version
appears

If this icon to the left of your SOP, there are additional steps required to obtain/view the pdf
version. Highlight the LATEST version:
o
Go to View, Versions
o
o
o
Double Click Latest Version
Click the box next to the SOP
Go to View, Content,
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Version: 16.0
Author: Kim Fedele
Page: 31 of 35
Attachment V: Viewing Cross-Referenced Departments MIDAS
When you retrieve an SOP in MIDAS, make sure you ALWAYS highlight the SOP and “View”, “Versions” to ensure you’re
viewing the CURRENT, EFFECTIVE version.

Click the blue icon
next to “, Current Effective ” SOP. This will open the MIDAS properties menu.
 On the “Properties” menu, select the “SOP/SOG” tab
 The departments are listed in the “SOP Organization Use Cross-Reference” section, beginning with (and
including) the SOP’s owning department.
Note: If you see the scroll arrows to the far right,
departments at a time.
there are more departments listed. The window can only display 3
APPROVED Planned Effective Date:16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 32 of 35
Attachment VI: SOP Process Flow Chart
APPROVED Planned Effective Date:16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Attachment VII: Electronic Logbook (eLog) Process Flow Chart
Page: 33 of 35
APPROVED Planned Effective Date:16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 34 of 35
Attachment VIII
Training Decision Tree
APPROVED Planned Effective Date:16-JAN-2019 GMT-0500
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Document Number:
10-QUA-001X
Version: 16.0
STANDARD OPERATING PROCEDURE
West Point, PA
Title: SOP Management
Author: Kim Fedele
Page: 35 of 35
Attachment IX
Training Decision Definitions
Complexity of Procedure
Simple: Easy to understand and comprehend by reading
through once.
Complex: Consists of interconnected parts with multiple components. Made up of
units and parts which are difficult to understand.
– Information is clear and easy to follow
– Information presented in a linear sequence
– If your procedure does not meet the criteria of SIMPLE it will be considered complex.
– One review of the procedure leaves learner with clarity on
what actions to take and roles/responsibilities
Examples:
Examples:
– Filter Prep SOP
Site Access SOP
– Manual Tank CIP/SIP Procedure
– Sterile Filtration
Magnitude of Change
No Change
Minor
Major
– These changes require the employees to learn new knowledge, a
new skill, new behavior by enforcing new expectation.
– A change with no impact to
knowledge or skills.
– These Changes require new knowledge.
– Alters the concept of the document.
– Does not alter the concept of the
document or steps taken by the
user
– Significantly alters document contents such as but not limited to;
process, job functions and job responsibilities.
– Minimal procedural change of one or two
points that is able to be independently
reviewed.
– These changes significantly alter either the actual task(s) employees
perform or the manner in which they perform the task(s).
– Demonstration may be required. Additional training required for
knowledge and skill transfer.
APPROVED Planned Effective Date: 16-JAN-2019 GMT-0500
DOCUMENT APPROVALS
Document ID:
Document Name:
0901435085f50784
10-QUA-001X SOP Management
Server Date
Signed by
Outcome
14-Nov-2018 13:24 GMT-0500
Reason for Signature
Derban,William J.
Quality, approval
Approve
19-Nov-2018 15:03 GMT-0500
Reason for Signature
Thomas,Kelley A.
Quality Approval
Approve
14-Nov-2018 10:26 GMT-0500
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Reason for Signature
Fedele, Kimberly
Approval, Authorization
Approve
HOW TO PREPARE A
STANDARD OPERATING
PROCEDURE
BME/CHE 460
Widener University
Standard Operating Procedure
2
Standard Operating Procedures – SOP
• SOPs are written processes that describe in detail how to
perform a work task specific to your operations.
Documenting standards properly allows businesses to
comply with regulatory and quality standards, train more
effectively, and enable a culture of continuous
improvement.
Standard Operating Procedure
3
Traditional Work Instructions
• Work instructions provide the same benefits of standard
operating procedures, but give more detail to the worker
in order to instruct on how to complete a task with little to
no prior knowledge. In short, work instructions are the
how-to guides of your operations.
Standard Operating Procedure
4
What is the difference between a process
and a standard operating procedure?
• Processes and procedures each include step-by-step
instructions to help you to correctly perform a specific
task. A process usually works at a higher level while a
standard operating procedure takes the elements of a
high-level process and adds more detail, specific
assignments, and workflows to conform with
company or industry standards.
• Don’t need an SOP to program a drum machine
because there are too many variables. There are no
standard drum sounds that you have to use to create
a beat.
Standard Operating Procedure
5
Standard Operating Procedure
In an SOP, you also describe what needs to happen for an
outcome. In addition, you would include more detailed
steps and information such as who, when, and where. Here
are a few reasons you may need an SOP:
• To ensure compliance standards are met
• To maximize production requirements
• To ensure the procedure has no adverse impact on the
environment
• To ensure safety
• To adhere to a schedule
• To prevent manufacturing failures
• To be used for training
Standard Operating Procedure
6
How do you write a standard operating
procedure document?
• Should have well-defined SOP documents that
will help your employees understand how to
perform routine jobs safely, in compliance with
regulations, and consistently no matter who
completes the task.
• There is no single official standard operating
procedure template in our industry.
Standard Operating Procedure
7
Step 1: Begin with the End in Mind
• Define what the end result or the goal is for the SOP you
•
•
•
•
are writing. E.g. the way to Turn-off Production Equipment
This step does not include details such as cleaning floors
or arming alarm systems. You simply want to identify what
the procedure will accomplish.
All organizations have processes and procedures that are
repeated daily, weekly, and monthly. As you define your
goals, ask whether an SOP document is needed for that
particular goal.
Ask yourself if there is a specific reason why this goal
should be accompanied by a standard operating
procedure document.
When you know what you want your SOP to accomplish,
it’s much easier to write an outline and define the details.
Standard Operating Procedure
8
Step 2: Choose a Format
If the company already has some SOP documents that have been
written for other procedures in the past. you can simply refer to those
documents as templates for preferred formatting guidelines.
If you don’t have any documents to use as a reference, try one of these
ideas:
• A simple steps format: Use this format for routine procedures that
are short and easy to follow. In addition to safety guidelines and other
mandatory documentation, this type of format is generally a simple
numbered or bulleted list with short, simple sentences that are clear
and easy for the reader to follow.
• A hierarchical steps format: If your procedures have a lot of steps
that involve some decisions, you may want to use the hierarchical
steps format. This is usually a bulleted or numbered list of main steps
followed by a set of specific sub-steps.
• A flowchart format: You may want to use a flowchart to map out and
plan procedures that include many possible outcomes. This is a good
choice when the results are not always predictable.
Standard Operating Procedure
9
Standard Operating Procedure
10
Step 3: Ask for Input
• Get the operation team together and ask them
how they think the job should be performed.
• These are the people who you are going to ask to
adhere to the SOP, so you want to be sure that it
makes sense to them and that all the necessary
tasks are included.
• There will be multiple drafts and reviews—make
sure you invite your team to review the drafts so
they can make additional suggestions.
Standard Operating Procedure
11
Step 4: Define the Scope
• It’s possible that the SOP you are working on is
dependent on other SOPs and teams in other
departments in order to be completed
successfully. Determine whether it is sufficient to
reference those other procedures or if you need
to add them to the current standard operating
procedure document.
• A organizational chart and a process map to
clearly define dependencies and responsible
parties.
Standard Operating Procedure
12
Step 5: Identify your audience
• What is their prior knowledge? Are they already familiar with the
organization and the procedures? Do they already know the
terminology? Have they become complacent and need a refresher?
You need to write to your audience’s knowledge level—dumb it down
too much or make it too complicated, and you’ll lose them.
• What are their language skills? Maybe your audience does not
natively speak your language. If that is the case, you may want to use
more pictures than words.
• Are they new employees? When bringing on new employees, your
SOP documents need to be very detailed and training-oriented. You
want to ensure consistent outcomes regardless of who is performing
a task.
• What is the size of your audience? Will multiple people in different
roles across multiple organizations be reading the document? If so,
you may want to write the procedures in a way that clearly defines
who, or what role, performs each task. This helps your audience
understand where they each fit into the process and why their
particular part is important.
Standard Operating Procedure
13
Step 6: Write the SOP
Title page can include:
• The title of the procedure
• An SOP identification number
• A publication date or revision date
• The name of the role, organization, division, or
agency that the SOP applies to
• Names and signatures of those who prepared
and approved the procedures outlined in the SOP
Standard Operating Procedure
14
Step 6: Write the SOP (cont.)
Table of contents
• You only need a table of contents if the document
is very large with many pages. The table of
contents allows easy access to specific areas of
the document.
Standard Operating Procedure
15
Step 6: Write the SOP (cont.)
The specific procedures are the main body of the document and includes
the specific step-by-step procedures that need to be followed in order to
successfully comply with company standards and safety regulations that
should include:
• Descriptions of the scope and purpose of the SOP, its limits, and how it’s
used. You can include standards, regulatory requirements, roles and
responsibilities, and inputs and outputs.
• Necessary details are needed to complete each step. Discuss decisions
that need to be made, possible quality and safety considerations, and any
other “what if” scenarios that may arise.
• Clarification of terminology, including acronyms and phrases.
• Health and safety warnings and list of equipment/supplies must be listed
in a separate section, and they should accompany applicable steps within
the process.
• Troubleshooting section to cover things that can go wrong, what types of
things should look for, and what may interfere with the final outcome.
Standard Operating Procedure
16
Step 7: Review, Test, Edit, Repeat
After you have written your standard operating procedure
document:
• Send a draft of the SOP to team members for review. Have
them note grammatical and technical errors.
• Test the document to ensure that you achieve the desired
outcome to ensure the language is clear, can be easily
followed, and can be completed successfully.
• Have operational management and quality representative
review the procedures to ensure that the Incorporate relevant
edits and suggestions. Repeat these steps until the document
is approved and accepted by all stakeholders.
• Follow company SOP management procedure and policy to
submit new SOP for final review and approval.
• Implement the SOP. Make it easily accessible to those who
need it to do their jobs.
Standard Operating Procedure
17
Step 8: Training and Update SOP
• Provide necessary training to affected personnel prior to
fully implement the SOP to the operations
• Frequently review and update the SOP wherever and
whenever needed
• Equipment changes
• Process changes
• Procedure changes
• Quality requirements changes
• Etc.
• Follow company SOP management requirements and
policy to review and update the SOP at pre-agreed
timeline

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