Preparation for GMP Audit in Pharmaceuticals
🏭 Preparation for GMP Audit in Pharmaceuticals
1. Understand the Audit Scope
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Know whether it’s regulatory (FDA, EMA, MHRA, WHO, CDSCO), customer, or internal.
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Review previous audit/inspection reports and ensure CAPAs are implemented.
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Be aware of current guidelines, SOPs, and regulatory updates relevant to your site.
2. Documentation Readiness (ALCOA+ Compliance)
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Ensure SOPs, BMRs, logbooks, and records are current, approved, and accessible.
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Documents should be complete, legible, contemporaneous, and error-free.
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Prepare a document index for quick retrieval during audit.
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Verify that electronic systems (LIMS, HPLC, GC, etc.) have audit trails enabled.
3. Facility & Equipment Preparedness
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Cleanliness and maintenance of all production, QC, and warehouse areas.
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Ensure equipment qualification (IQ/OQ/PQ) and calibration records are up-to-date.
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Check status labels on equipment: Cleaned / In-use / Under maintenance.
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Verify environmental monitoring, HVAC, water system, and utilities are validated.
4. Personnel Training & Awareness
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All employees should know GMP basics, SOPs, and their roles.
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Conduct mock audits or Q&A sessions to prepare staff for inspector interaction.
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Ensure proper gowning and hygiene practices in controlled areas.
5. Quality Systems Preparedness
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Deviation & OOS/OOT: All must be properly investigated and closed.
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CAPA: Evidence of effectiveness checks must be available.
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Change Control: Ensure impact assessments and approvals are documented.
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Complaints & Recalls: Review logs and ensure procedures are updated.
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Data Integrity: No shared logins, password controls, and backup in place.
6. Batch & Product Readiness
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Select a few recently manufactured batches and ensure all documents are complete.
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Review batch records for completeness, signatures, and reconciliation.
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Ensure raw materials, intermediates, and finished goods are traceable.
7. Housekeeping & Visual Readiness
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Remove expired or obsolete labels, raw materials, or equipment from the area.
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Ensure segregation of materials (Quarantine, Released, Rejected).
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Keep warehouse and dispensing areas tidy and compliant with SOPs.
8. Communication & Audit Handling
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Assign a coordinator to handle document requests and inspector movement.
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Train staff to answer only what is asked—clearly and truthfully.
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Prepare an audit room with required references, internet access, and support staff.
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Ensure timely retrieval of documents and data without delays.
📌 Quick Pre-Audit Checklist
✅ Documents updated & accessible
✅ Equipment calibrated & qualified
✅ Areas clean, well-labeled, and organized
✅ Personnel trained & confident
✅ Quality systems reviewed (OOS, CAPA, Change Control)
✅ Mock audit conducted
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