A Standard Operating Procedure SOP for Management of Documents is crucial in pharmaceutical manufacturing to ensure the control, organization, and traceability of documents. The following is a general outline for creating an SOP for the Management of Documents

Purpose

SOP for Management of Documents Scope

Responsibilities

1. It is the responsibility of QA to prepare, manage and properly implement this SOP.
2. QA ensures that this SOP is followed in its entirety.
3. It is the responsibility of QA Manager or Designee to review this SOP.
4. It is the responsibility of QA Head or Designee to approve this SOP.
5. It is the responsibility of Director Technical / Operations to authorize this SOP.

Definitions & Abbreviations

1. Effective Date: The date when document is implemented.
2. cGMP: Current Good Manufacturing Practices
3. HOD(s): Head of Department(s)

Departmental Codes

1. QA: Quality Assurance
2. QC: Quality Control
3. PR: Production
4. EG: Engineering
5. AD: Administration
6. PU: Procurement
7. AC: Accounts
8. IT:  Information Technology
9. WH: Warehouse
10. RG: Regulatory Affairs
11. RD: Research & Development
12. EX: Export

Document Level SOP for Management of Documents

1. POL: Policy
2. SOP: Standard Operating Procedure
3. VMP: Validation Master Plan
4. SPC: Specifications
5. SMF: Site Master File
6. TMP: Templates
7. REC: Records
8. FRM: Forms
9. BPR: Batch Processing Record
10. BMR: Batch Manufacturing Record

Document Type

1. GR: General Regulations
2. QM: Quality Management System Related Documents
3. OP: Operational SOPs
4. CL: Cleaning SOPs
5. RM: Raw material Testing Related Documents
6. IP: In process Testing Related Documents
7. FG: Finished Good Testing Related Documents
8. MI: Microbiology Testing Related Documents
9. PM: Packaging Material Testing Related Documents
10. ST: Stability Related Documents
11. SG: Storage Related Documents
12. PV: Process Validation Related Documents
13. MV: Method Validation Related Documents
14. CV: Cleaning Validation Related Documents
15. PD: Product Development Related Documents
16. DQ: Design Qualification Related Documents
17. IQ: Installation Qualification Related Documents
18. OQ: Operational Qualification Related Documents
19. PQ: Performance Qualification Related Document
20. UR: User Required Related Documents

Procedures

Levels of Documentation.

1. Levels of Documents are categorized on the basis of authorizing person and access control.

Level: 1

• Authorized by top management (i.e. CEO or Director Technical / Operations).
• Includes Company Policies, Site Master File, Quality System Manual & Organizational Chart and Validation Master Plan.
• Access control is limited to Directors and HODs only.
• SOP for Management of Documents

3Level: 2

• Authorized by Director Technical / Operations or QA Manager or Designee.
• Includes cGMP SOPs, General SOPs (Cleaning, Operational, Calibration, Stability, Validation, Standardization and Qualification).
• Access control is limited to technical persons.

4 Level: 3

• Authorized by QA Manager or Designee.
• Includes Analytical Procedures & Reports (Product related analytical procedure, QC specifications, Reports of Raw Materials / Packing Materials, Finished goods reports / Micro reports / Certificates Stability reports).
• Access control is limited to relevant persons.

Level: 4

• Authorized by QA Manager or Designee.
• Includes records and documents generated from level 1, 2 & 3 (Temperature / Humidity sheets, Standardization formats, Daily Cleaning & Hygiene reports, Validation / Qualification reports, Stability templates, Log Books, Templates, Forms).
• Access control is generalized to relevant departments.

Format of SOP

Document number

• Example: QA/SOP/QM/0004 is the 4th SOP of QA department related to Quality Management System
• Example: QC/SOP/IP/0005 is the 5th SOP of QC department related to In Process Testing
• Example: PR/SOP/CL/0002 is the 2nd SOP of Production department related to Cleaning of Equipment

• Height of the header from top is 0.3″
• Individual row height is exactly 0.35″
• Place following information on the header of each page of SOP

1. Company name, address and logo
2. Department name
3. Document number
4. Revision number
5. Effective date
6. Review Due Date
7. Title of SOP
8. Page X of Y

Copy Number

• Stamp copy number on each page of the distributed copy on right side of the header

Revision number

• Composed of two digits e.g. 01 means SOP has been revised and 01 is the first revision of SOP.
• Revision 00 will be the 1st Version of the document.

Footer SOP for Management of Documents

• Height of the footer from bottom is 0.2″
• Individual row height is exactly 0.35″
• Place following information on the footer of each page of SOP

1. Name of person written by / reviewed by / approved by / authorized by
2. Designation of person written by / reviewed by / approved by / authorized by
3. Signature with date of person written by / reviewed by / approved by / authorized by
4. SOP for Management of Documents

Font Style & Size

• The font style is Times New Roman
• The font size is 12 (For all documents) and title font size is 14.
• The headings are kept bold.

Contents SOP for Management of Documents

• Purpose: A brief statement describing purpose of SOP.
• Scope: Department, section and / or unit where SOP is applicable.
• Responsibilities: All those who are involved in preparation, review, approval, authorization and implementation of SOP.
• Definitions & Abbreviations: Define all terminologies used in SOP.

• Safety Considerations: All safety precaution should be outline in this Sub heading (if required)
• Materials & Equipment: Describe materials and equipment in this Sub heading (if required)
• Describe in details of all required steps to perform intended activities.
• Attached Documents: Enlist the attached documents generated by SOP with their numbers.
• Reference & Linked Documents: Guidelines from which content of SOP is taken and Documents necessary to implement SOP.
• Revision History: To keep the history of SOP, record the revision date, responsible person / designation and description of change in revision history column, when the Revision is required to change.
• Distribution List: List of recipients of SOP.
• Annexure: Attachment of any document with the SOP (if required).

Approval of Document (See Annexure A)

• HOD accesses the need of new document and title of document is determined.
• Technical person generates electronic document and contact QA to issue document number and forwards it to his / her supervisor for technical review.
• Supervisor reviews document for technical and grammatical correctness and forwards E-copy to QA for printing.
• QA provides a hard copy of document to HOD for final review and approval.
• Prior to authorization, training is conducted of concerned staff as per SOP for Training.
• In case of any change, HOD completes the “Document Change Request Form” for revision change and forwards to QA Manager for approval.
• When doing three years review of document, the document change request should be filled by HOD.
• Change request can be triggered within the company or by regulators.

Authorization and Distribution of Document

• After successful training, Document is signed by authorized person as per defined criteria in 5.1 Levels of Documentation.
• Copy number, effective date and Review Due Date are stamped and distributed to the relevant departments.
• The original document should be kept in QA after authorization signature as a Master Document, and print should be on single page one side.
• If any copy of Document is required for auditor or any Govt. authority, QA makes copy for that and stamp in RED COLOUR on each page “UNCONTROLLED COPY”
• Document are issued to each departmental head are stamped as “COPY NO. 01”, “COPY No. 02” and so on in BLUE COLOUR on each page.
• Each recipient receives a copy of the document, each recipient copy should be marked with copy number (01,02,03,…….) and should be stamped on the right side of the header.
• In case when document has been revised, before distribution of new Revision of document, previous Revision (Obsolete copies) is collected and destroyed except Master Document for tracking purpose. Document considers obsolete is stamped “OBSOLETE” in red colour.

Review Frequency

• All documents are subject to review on three years basis or when required.
• If there are any changes, the document should be immediately revised.
• If there is no change to SOP after 03 years, a new print should be issued, reviewed, authorized with a new Revision number.

Forms Preparation:

• Once title of Form is determined, contact QA to obtain Form number.
• Form number is composed of seven digits:

• AA: Refers to department.
• BBB: Refers to Level of Document (FRM for Forms)
• 0000: Sequential Number of SOP
• 00: Sequential Number of forms related to SOP

• Height of the Header from top is 0.3″
• Individual row height is exactly 0.35″
• Company name, Logo, Department, Reference SOP, Document number, Revision number Effective date and Review Due Date
• Title of Form will appear at header.

• Height of the footer from bottom is 0.2″
• Individual row height is exactly 0.3″
• Name of person, Designation and Signature with Date of written by / reviewed by / approved by / authorized by
• Page number appears at footer.

Document Archiving

1. The hard and soft versions of original document “Master Document” and “Obsolete Document” will be kept by QA only.
2. Each department will have only one hard copy of the master document.
3. Supporting data can be stored by relevant department.

Attached Documents (Forms / Annexure)

• Document Control Flow Diagram (Annexure A)
• Format of SOP (Annexure B)
• Format of Form (Annexure C)
• Master List of Documents (QA/FRM/0000/00)

Reference & Linked Documents

1. Code of Federal Regulations, CFR Part 160 Good Laboratory Practice Standards
2. ISO 9001:2015 Standards
3. Guidance for Preparing Standard Operating Procedures EPA-QA/G-0
4. MDSAP QMS Document Control & Approval Procedure MDSAP QMS P0000.000
5. SOP for Change Control
6. SOP for Training