3. Responsibilities

• Document Owner: Prepare draft documents and initiate revision as per process requirement.
• QA Document Control Coordinator: Maintain document lifecycle, assign numbers, track distribution, archive superseded documents.
• Department Heads: Review and approve relevant documents for correctness and applicability.
• QA Head: Final approval authority for issuing and controlling GMP documents.

4. Accountability

The Head of Quality Assurance is accountable for compliance with this SOP and for ensuring controlled document management throughout the organization.

5. Procedure

5.1 Document Classification

1. Documents covered under this SOP include:
   • Standard Operating Procedures (SOPs)
   • Batch Records (BMR, BPR)
   • Specifications and Analytical Methods
   • Protocols and Reports
   • Forms and Logbooks
   • Manuals (e.g., Equipment Manuals, User Guides)

5.2 Document Numbering System

1. Each controlled document shall bear a unique identifier in the format: Document Type/Department/Serial No./Year
2. Examples:
   • SOP/API/166/2025
   • BMR/API/017/2025
3. The number is assigned by QA Document Control upon request for document creation.

5.3 Document Preparation

1. The initiator drafts the document in the prescribed format including:
   • Title
   • Purpose, Scope, Responsibility, Procedure
   • Version and Revision History
2. All sections should be clear, concise, and written in instructional language.
3. Submit draft for review by the department head and then QA.

5.4 Document Review and Approval

1. Reviewed by:
   • Initiating Department Head
   • QA Head
   • Additional functional reviewers (if applicable)
2. Once approved, QA assigns the effective date and final version number.
3. Record approval details in the Document Control Register (Annexure-1).

5.5 Document Issuance and Distribution

1. QA shall issue controlled hard copies with “Controlled Copy” stamp and serial number on each page.
2. Document Distribution Sheet (Annexure-2) shall be maintained and signed by recipients.
3. Original master copy shall be retained in QA Document Control Room.

5.6 Document Revision and Obsolete Document Handling

1. Any changes shall follow the change control process and must be documented in the revision history.
2. Superseded documents shall be:
   • Stamped “Obsolete”
   • Withdrawn from user areas
   • Archived with traceability (Annexure-3)
3. Distribute revised copies only after old copies are retrieved.

5.7 Uncontrolled Copies

1. Uncontrolled copies are issued only for reference or external purposes.
2. Each page shall be marked as “Uncontrolled Copy.”
3. Requests must be approved by QA Head.

5.8 Electronic Document Control

1. If a validated Document Management System (DMS) is used:
   • Only authorized users may access/edit
   • Audit trails must be enabled
   • Electronic signatures should comply with 21 CFR Part 11
2. Backup and retention policies shall be followed as per IT SOPs.

5.9 Logbook Control

1. All GMP logbooks shall be:
   • Numbered and recorded in Logbook Register (Annexure-4)
   • Issued by QA with start and end page
   • Stamped and sealed with QA initials

5.10 Archival and Retention

1. Documents shall be archived as follows:
   • Batch Records – 5 years or product shelf life + 1 year
   • SOPs and QA Records – Minimum 5 years after supersession
2. Archived in secure fire-proof cabinets under restricted access.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• DMS: Document Management System
• GMP: Good Manufacturing Practice

7. Documents

1. Document Control Register (Annexure-1)
2. Document Distribution Sheet (Annexure-2)
3. Obsolete Document Log (Annexure-3)
4. Logbook Issue Register (Annexure-4)

8. References

• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211.180 – Documentation
• EU GMP – Chapter 4 Documentation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Document Control Register

Doc No.	Title	Version	Effective Date	Status
SOP/API/166/2025	Document Control and Distribution	2.0	16/04/2025	Active

Annexure-2: Document Distribution Sheet

Doc No.	Recipient Dept	Copy No.	Date Issued	Received By
SOP/API/166/2025	Production	001	15/04/2025	Sunita Reddy

Annexure-3: Obsolete Document Log

Doc No.	Title	Superseded On	Archived Location
SOP/API/166/2022	Document Control	14/04/2025	QA Archive Room Shelf B

Annexure-4: Logbook Issue Register

Logbook ID	Department	Issued By	Date	Pages
LOG-API-2025-014	QC	QA Officer	10/04/2025	1-100

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Version	Document system implementation	QA Head
14/04/2025	2.0	Expanded coverage of electronic documentation	Audit compliance	QA Head