PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF)

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PREPARATION, REVIEW, CONTROL AND REVISION OF SITE MASTER FILE (SMF)

1.0 OBJECTIVE

To describe the procedure for preparation, review, approval, control, and revision of the Site Master File (SMF).

2.0 SCOPE

This SOP is applicable to the preparation and maintenance of the Site Master File covering:

  • Facility

  • Premises

  • Equipment

  • Personnel

  • Quality Management System

  • Utilities

3.0 RESPONSIBILITY

3.1 Officer / Executive – QA

3.1.1 Preparation of the Site Master File.

3.2 Concerned Department Head

3.2.1 Review of Site Master File for adequacy, accuracy, and completeness.

3.3 Head – QA

3.3.1 Ensure implementation and compliance of this SOP.
3.3.2 Approval of Site Master File prior to authorization.

4.0 ACCOUNTABILITY

Head – Quality Assurance shall be accountable for overall implementation, control, and compliance of this SOP.

5.0 DEFINITION & ABBREVIATION

5.1 Definitions

Site Master File (SMF):
A document containing factual and specific information about the production and/or control of pharmaceutical manufacturing operations carried out at the licensed premises.

5.2 Abbreviations

Abbreviation Description
SOP Standard Operating Procedure
QA Quality Assurance
SMF Site Master File

6.0 PRECAUTIONS, SAFETY & EHS

Not Applicable.

7.0 MATERIAL & EQUIPMENT REQUIRED

7.1 Materials: N.A.
7.2 Equipment: N.A.

8.0 PROCEDURE

8.1 Preparation of Site Master File

8.1.1 Site Master File shall be prepared during the initial stage of commissioning of the facility after finalization of:

  • Civil design

  • Equipment type and models

  • Utility systems

  • Approved layout drawings

8.1.2 Quality Assurance shall prepare the Site Master File.

8.1.3 The Site Master File shall contain adequate information and normally not exceed 25–30 pages, excluding appendices.

8.1.4 Wherever possible, simple plans, outline drawings, or schematic layouts shall be used instead of lengthy narratives.

8.1.5 The SMF including annexures shall be legible when printed on A4 size paper.

8.2 Approval of Site Master File

8.2.1 The Site Master File shall be:

  • Prepared by QA

  • Reviewed by concerned department heads

  • Approved by Head – QA

  • Authorized by Plant Head

8.2.2 The first approval page shall be signed by:

  • QA Head

  • Head – Quality

  • Plant Head

8.3 Document Numbering System

The numbering format for Site Master File shall be:

XX/YYY/SMF-ZZZ

Where:

  • XX : Short name of Company/Site

  • YYY : Quality Assurance Department

  • SMF : Site Master File

  • ZZZ : Document number starting from 001

Example: CO/QA/SMF-001

8.4 First Page Requirements

The first page of the Site Master File shall contain:

  • Name and Address of Site

  • Title: Site Master File (SMF)

  • Document Number (XX/YYY/SMF-ZZZ)

  • Revision Number

  • Effective Date

  • Review Date

8.5 Contents of Site Master File

The SMF shall include the following sections:

1.0 General Information on the Manufacturer

1.1 Contact Information
1.2 Authorized Pharmaceutical Manufacturing Activities of the Site
1.3 Any Other Manufacturing Activity Carried Out at the Site

2.0 Quality Management

2.1 Description of Quality Management System
2.2 Release Procedure of Finished Products
2.3 Management of Suppliers and Contractors
2.4 Quality Risk Management (QRM)
2.5 Product Quality Reviews

3.0 Personnel

4.0 Premises and Equipment

4.1 Premises

4.1.1 Brief Description of HVAC Systems
4.1.2 Brief Description of Water Systems
4.1.3 Description of Other Utilities (Steam, Compressed Air, Nitrogen, etc.)

4.2 Equipment

4.2.1 List of Major Production and Laboratory Equipment
4.2.2 Cleaning and Sanitation Systems
4.2.3 GMP-Critical Computerized Systems

5.0 Documentation

6.0 Production

6.1 Types of Products
6.2 Process Validation
6.3 Materials Management and Warehousing

7.0 Quality Control

8.0 Distribution, Complaints, Product Defects and Recalls

8.1 Distribution Recording System
8.2 Complaint Handling and Recall Procedures

9.0 Self-Inspection

10.0 Reference

11.0 Revision History

8.6 Annexures

8.6.1 Relevant information shall be attached as annexures, such as:

  • Organization Chart (Organogram)

  • Layout of Manufacturing Areas

  • Warehouse Layout

  • Utility Layout

  • List of Major Equipment

8.6.2 Annexures may be revised separately without revising the main SMF document.

8.6.3 When SMF is revised, annexure numbers shall be updated with revision suffix “00” corresponding to the current SMF revision number.

8.7 Revision and Change Control

8.7.1 Any modification to the Site Master File shall be handled through Change Control.

8.7.2 Changes shall be recorded in the Revision History section with reference to Change Control number.

8.7.3 Minor updates may be issued as an “Addendum” to the existing SMF.

8.7.4 Addendum shall be incorporated into the next full revision of the SMF.

8.8 Periodic Review

8.8.1 Site Master File shall be reviewed periodically or whenever:

  • Major changes occur in facility or equipment

  • Change in manufacturing activity

  • Regulatory updates

  • Organizational restructuring

8.8.2 Review date shall be mentioned on the SMF first page.

9.0 ENCLOSURES

Annexure – I: Site Master File Template

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