Guidelines for Preparation of Site Master File (SMF)
🏭 Guidelines for Preparation of Site Master File (SMF)
📑 1. General Information
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Company name, address, and contact details.
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Name of parent company (if applicable).
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Manufacturing activities performed at the site.
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Products handled (human, veterinary, APIs, biologicals, etc.).
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Manufacturing license and regulatory approvals.
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Organizational structure with key personnel and their qualifications.
🏢 2. Quality Management System (QMS)
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Description of QMS and its scope.
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Management responsibilities and GMP policy.
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Procedures for handling deviations, OOS, OOT, and CAPA.
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Change control system.
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Internal audit/self-inspection system.
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Product quality review (PQR) process.
👩🔬 3. Personnel
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Organization chart (QA, QC, Production, Engineering).
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Key personnel responsibilities (Head QA, Head QC, Production Manager).
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Training systems (GMP, safety, technical).
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Health and hygiene requirements (medical checks, gowning, restrictions).
🏭 4. Premises & Facilities
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Site layout and floor plans (flow of materials and personnel).
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Production areas (oral, sterile, non-sterile, packaging).
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Storage areas (quarantine, released, rejected, returned, cold rooms).
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Ancillary areas (change rooms, cafeterias, offices).
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Utilities: water systems (PW, WFI), HVAC, compressed air, cleanrooms.
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Pest control measures.
⚙️ 5. Equipment
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List of major equipment used in production and QC.
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Qualification and calibration practices.
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Cleaning and preventive maintenance systems.
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Status labeling (Cleaned, In-Use, Out of Service).
📦 6. Documentation
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System for SOPs, records, logbooks, batch records.
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Document control, approval, and archival.
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Data integrity policy (audit trails, electronic systems).
🧪 7. Production
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Types of products manufactured.
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Flowcharts for manufacturing processes (e.g., tablet, capsule, injection).
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Cross-contamination control measures.
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Handling of starting materials, intermediates, and finished products.
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Packaging and labeling controls.
🧫 8. Quality Control (QC)
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Description of QC laboratory facilities.
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List of instruments (HPLC, GC, UV, etc.).
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Sampling procedures.
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Specifications, reference standards, and reagents handling.
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Stability testing program.
🚚 9. Storage, Distribution & Complaints
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Storage practices (temperature, humidity monitoring, FEFO/FIFO).
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Transportation and cold chain control.
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Complaint handling procedure.
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Recall system (mock recalls, effectiveness checks).
♻️ 10. Validation & Qualification
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Master Validation Plan (MVP).
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Process validation, cleaning validation, analytical method validation.
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Equipment/utility qualification (DQ/IQ/OQ/PQ).
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Computerized system validation.
🔒 11. Contract Activities
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Details of contract manufacturers, laboratories, and service providers.
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Technical/quality agreements.
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Oversight and audits of contractors.
🧾 12. Other Relevant Information
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Handling of returned, rejected, and recalled products.
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Handling of counterfeit or falsified medicines.
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Product security and data protection measures.
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Environmental, health, and safety measures.
📌 Key Notes for SMF Preparation
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Keep it concise (25–30 pages max) – provide summaries, not full SOPs.
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Include flowcharts, diagrams, and layouts for clarity.
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Ensure consistency with actual practices (inspectors will verify on-site).
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Review and update regularly (at least annually or after major changes).
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