Guidelines for Preparation of Site Master File (SMF)
📘 Guidelines for Preparation of Site Master File (SMF)
The Site Master File (SMF) is a regulatory document that provides detailed information about a pharmaceutical manufacturing site, operations, and quality management system. It is required by WHO, EU GMP (Annex 15), PIC/S, and many regulatory agencies.
The SMF should be a concise, factual, and updated document (usually not exceeding 25–30 pages, excluding annexes).
🔹 General Requirements
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Written in English (or language acceptable to the authority).
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Signed and approved by the Head of Quality Assurance or Site Head.
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Reviewed and updated regularly (typically every 1–2 years or after significant changes).
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Should describe only the site for which it is prepared (not corporate-level details).
🔹 Typical Structure of SMF
1. General Information
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Brief information on the manufacturer:
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Company name, site address, contact details.
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Manufacturing license(s) and GMP certificates.
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Activities performed (e.g., production, packaging, testing).
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Products manufactured (categories: sterile, non-sterile, APIs, dosage forms).
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Organization chart showing key personnel.
2. Quality Management System (QMS)
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Description of the quality management principles applied.
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Details of:
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Documentation system (SOPs, policies, controlled documents).
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Change control and deviation handling.
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CAPA and risk management.
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Self-inspections and audits.
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Product Quality Reviews (APR/PQR).
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3. Personnel
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Number of employees in production, QC, QA, engineering.
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Key responsibilities of senior management.
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Training and hygiene programs.
4. Premises and Equipment
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Layout of manufacturing facility (block diagrams or floor plans).
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HVAC classification and environmental controls.
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Major equipment (list or summary).
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Preventive maintenance and calibration practices.
5. Documentation
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Master documents (BMR, BPR, specifications, SOPs).
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Electronic data management and data integrity compliance.
6. Production
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Types of dosage forms manufactured.
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Manufacturing operations and process flow.
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In-process controls and line clearance.
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Cross-contamination controls and material handling.
7. Quality Control
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Testing facilities available (chemical, microbiological, instrumental).
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Stability testing program.
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Reference standard management.
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Data integrity and audit trail practices.
8. Distribution, Complaints, and Product Recall
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Distribution system and traceability.
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Handling of complaints and recalls.
9. Self-Inspection
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Frequency and scope of internal audits.
10. Annexures
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List of authorized products.
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Site and floor plans.
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Major equipment list.
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Personnel organogram.
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List of GMP certificates or approvals.
🔹 Best Practices in Preparing SMF
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Keep it factual, not promotional.
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Use flowcharts and diagrams for clarity.
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Keep annexes for bulky information (equipment list, layouts).
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Ensure alignment with latest WHO TRS 961 Annex 14 or PIC/S PE 008 guidelines.
✅ Importance of SMF
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Provides regulators with an overview of the facility.
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Demonstrates GMP compliance and site readiness.
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Helps in inspection planning.
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Useful reference document for audits and quality agreements.
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