PHARMACEUTICAL SITE MASTER FILE (SMF) READINESS CHECKLIST 2026

Created by ChecklistGuro (https://checklistguro.com)


--- SITE INFORMATION AND GENERAL DESCRIPTION ---
[ ] Site Name and Official Address
[ ] Site Registration/License Number
[ ] Scope of Site Activities
[ ] Last SMF Review Date
[ ] Site Classification (Manufacturing Site, Testing Laboratory, Distribution Center, Packaging Site)
[ ] Site Map/Facility Layout
[ ] Reviewer Authorization

--- QUALITY MANAGEMENT SYSTEM (QMS) OVERVIEW ---
[ ] Quality Policy Statement Summary
[ ] QMS Certification Status (ISO 9001 Certified, GMP Compliant, ISO 13485 Certified, Other)
[ ] Included Quality Processes (Change Control, Deviation Management, CAPA, Risk Management, Audits, Training)
[ ] Last QMS Review Date
[ ] Quality Manual Reference
[ ] Quality Assurance Lead Verification

--- PERSONNEL AND ORGANIZATIONAL STRUCTURE ---
[ ] Organization Chart Version Number
[ ] Key Personnel Roles Verified (Quality Assurance Manager, , Quality Control Manager, Warehouse/Logistics Manager, Engineering/Maintenance Lead)
[ ] Last Organizational Structure Review Date
[ ] Updated Organizational Chart PDF
[ ] Training Program Compliance Status (Fully Compliant, Minor Gaps Identified, Non-Compliant)
[ ] Quality Assurance Auditor Verification

--- PREMISES AND EQUIPMENT DOCUMENTATION ---
[ ] Cleanroom Classification Status (ISO Class 5, ISO Class 7, ISO Class 8, Unclassified)
[ ] Last HVAC System Qualification Date
[ ] Equipment ID/Asset Number
[ ] Required Maintenance Logs Present (Preventative Maintenance Records, Calibration Certificates, Decontamination Logs, Pressure Differential Logs)
[ ] Facility Layout Blueprint/Map
[ ] Verification Officer Signature

--- DOCUMENTATION AND DATA INTEGRITY CONTROLS ---
[ ] Compliance Standards Verified (ALCOA+ Principles, 21 CFR Part 11 Compliance, EU Annex 11 Compliance, GDP (Good Documentation Practices))
[ ] Document Control Procedure ID
[ ] Last Document Review Date
[ ] Standard Operating Procedure (SOP) Evidence
[ ] Data Integrity Gap Analysis Summary
[ ] Quality Assurance Reviewer Signature

--- PRODUCTION AND PROCESS CONTROLS ---
[ ] Manufacturing Process Status (Validated, In-Progress/Validation Phase, Under Revision)
[ ] Production Area Compliance Checks (Line Clearance Completed, Material Reconciliation Performed, In-Process Samples Collected, Environmental Monitoring Verified)
[ ] Batch Production Date
[ ] Process Deviation Notes
[ ] Batch Record/Logbook Scan
[ ] Production Supervisor Verification

--- QUALITY CONTROL AND LABORATORY OPERATIONS ---
[ ] Laboratory Compliance Status (Fully Compliant, Minor Non-Compliance, , Critical Deficiency)
[ ] Last Analytical Method Validation Date
[ ] Testing Capabilities Present (HPLC/GC Analysis, Microbiological Testing, Dissolution Testing, Stability Testing, Spectroscopy (UV/IR))
[ ] Summary of Recent Out-of-Specification (OOS) Results
[ ] Reference Standard Certificate Upload
[ ] Laboratory Manager Verification

--- MATERIAL MANAGEMENT AND SUPPLY CHAIN ---
[ ] Raw Material Status (Quarantine, Released, Rejected, Returned)
[ ] Batch/Lot Number Verification
[ ] Date of Receipt
[ ] Expiry Date of Material
[ ] Quantity Received
[ ] Storage Condition Compliance (Ambient Temperature, Refrigerated (2-8°C), Frozen (-20°C or below), Controlled Humidity, Light Sensitive)
[ ] Certificate of Analysis (CoA) Upload
[ ] Quality Assurance Inspector Signature

--- VALIDATION AND QUALIFICATION PROGRAMS ---
[ ] Validation Master Plan (VMP) Status (Current and Valid, Under Revision, Expired/Needs Update)
[ ] Qualification Types Covered (Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Cleaning Validation, Process Validation)
[ ] Last Validation Audit Date
[ ] Next Scheduled Re-qualification Date
[ ] Summary of Critical Validation Gaps
[ ] Upload Validation Summary Report
[ ] QA Officer Approval Signature

--- SELF-INSPECTION AND AUDIT PROGRAM ---
[ ] Last Self-Inspection Date
[ ] Audit Frequency Compliance (Compliant, Non-Compliant, Partial Compliance)
[ ] Audit Scope Areas Covered (Production, Quality Control, Warehouse/Logistics, Engineering/Maintenance, IT/Data Integrity)
[ ] Summary of Major Findings
[ ] Upload Audit Report/Evidence
[ ] Quality Assurance Auditor Signature

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