maintaining the Site Master File for the API manufacturing facility. It includes preparation, formatting, content requirements, updates, version control, and approval of the SMF.

3. Responsibilities

• QA Executive: Prepares and formats the Site Master File as per regulatory templates.
• Department Heads: Provide relevant data for respective sections of the SMF.
• QA Manager: Reviews, approves, and ensures timely submission and revision of the SMF.

4. Accountability

The Head of Quality Assurance is accountable for ensuring the SMF is maintained in current and approved form, readily available for regulatory and customer audits, and reflects actual site practices and GMP compliance.

5. Procedure

5.1 Format and Template

1. The SMF shall be prepared in accordance with WHO TRS 961 Annex 14 or equivalent EMA/FDA templates (Annexure-1).
2. It shall be prepared in English, in editable and PDF formats.
3. The cover page must include:
   • Site name and address
   • Document title: Site Master File
   • Version number and effective date

5.2 Content of SMF

1. The SMF shall include but not be limited to the following sections:
   • 1. General Information about the Site
   • 2. Quality Management System
   • 3. Personnel
   • 4. Premises and Equipment
   • 5. Documentation
   • 6. Production
   • 7. Quality Control
   • 8. Distribution, Complaints, Product Recall
   • 9. Self Inspection
   • 10. Appendices (plant layout, organogram, lists of SOPs and products)

5.3 Document Control and Versioning

1. Each version of the SMF shall have a unique version number (V1.0, V2.0, etc.) and approval date.
2. All changes to the SMF shall be recorded in the SMF Revision History Log (Annexure-2).
3. Previous versions shall be archived electronically with read-only access.

5.4 Data Collection and Verification

1. QA shall send data requisition forms (Annexure-3) to departments for sections like Personnel, Equipment, QC tests, SOPs, HVAC systems, etc.
2. Data must be verified by respective department heads before submission.
3. QA shall cross-check submitted information with current SOPs and batch records.

5.5 Review and Approval

1. QA Manager shall perform a final review of the SMF content for completeness, accuracy, and alignment with regulatory expectations.
2. Approval shall be documented in the SMF Approval Form (Annexure-4).

5.6 Periodic Review

1. The SMF shall be reviewed annually or upon:
   • Major organizational change
   • Facility expansion or renovation
   • Change in GMP scope (e.g., new product category)
2. Reviews shall be tracked in the Annual SMF Review Log (Annexure-5).

5.7 Distribution and Submission

1. Controlled copies of the SMF shall be provided to regulatory authorities or customers on request.
2. QA shall maintain a log of all shared versions in the SMF Distribution Register (Annexure-6).

6. Abbreviations

• SMF: Site Master File
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• WHO: World Health Organization

7. Documents

1. SMF Template (Annexure-1)
2. SMF Revision History Log (Annexure-2)
3. Departmental Data Requisition Form (Annexure-3)
4. SMF Approval Form (Annexure-4)
5. Annual SMF Review Log (Annexure-5)
6. SMF Distribution Register (Annexure-6)

8. References

• WHO TRS 961 Annex 14 – Site Master File
• ICH Q10 – Pharmaceutical Quality System
• 21 CFR Part 211 – GMP for Finished Pharmaceuticals
• EU GMP – Part II and Annex 15

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: SMF Template (As per WHO)

Detailed structure including 10 core sections (as listed in 5.2).

Annexure-2: SMF Revision History Log

Version	Date	Changes Made	Reason	Approved By
1.0	01/01/2022	Initial Draft	New File	QA Head
2.0	14/04/2025	Added HVAC System & Capacity Section	Audit Request	QA Head

Annexure-3: Departmental Data Requisition Form

Department	Section	Data Required	Submitted By	Date
Engineering	HVAC	Air flow diagram	Rajesh Kumar	12/04/2025

Annexure-4: SMF Approval Form

SMF Title	Version	Reviewed By	Approved By	Date
API Site Master File	V2.0	QA Manager	QA Head	14/04/2025

Annexure-5: Annual SMF Review Log

Review Year	Reviewer	Changes Required	Status
2025	Sunita Reddy	Yes – Added new product list	Completed

Annexure-6: SMF Distribution Register

Date	Version	Recipient	Purpose	Mode
13/04/2025	V2.0	CDSCO Inspector	Regulatory Submission	Email

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
14/04/2025	2.0	Template aligned with WHO TRS 961	Global Compliance	QA Head