What you should Inspect when Conducting Self-inspection in Pharmaceuticals
✅ Areas to Inspect During Self-Inspection in Pharmaceuticals
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Personnel & Training
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Verify staff qualifications, training records, and adherence to GMP practices.
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Premises & Facilities
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Check cleanliness, maintenance, pest control, HVAC systems, and environmental monitoring.
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Equipment & Instruments
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Ensure calibration, preventive maintenance, cleaning validation, and logbook entries are up to date.
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Documentation & Records
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Review SOPs, batch manufacturing records, logbooks, and compliance with ALCOA+ principles for data integrity.
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Raw Materials & Packaging Materials
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Inspect receipt, storage, sampling, dispensing, and labeling practices.
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Production Process
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Verify adherence to approved batch records, in-process checks, line clearance, and yield reconciliation.
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Quality Control (QC) Laboratory
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Check testing procedures, data integrity, instrument qualification, and OOS/OOT handling.
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Warehousing & Distribution
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Ensure proper segregation of materials, controlled storage conditions, and GDP compliance.
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Deviation, Change Control & CAPA
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Evaluate effectiveness of deviation handling, change control system, and CAPA implementation.
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Validation & Qualification
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Inspect equipment qualification, process validation, cleaning validation, and computerized system validation.
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Water & Utilities System
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Check purified water, WFI, compressed air, and gas systems for compliance and monitoring.
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Safety & Hygiene
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Verify personnel hygiene, gowning practices, waste management, and occupational safety measures.
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Contract Manufacturing & Suppliers
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Assess supplier qualification, vendor audits, and contract manufacturer oversight.
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Product Complaints & Recalls
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Review complaint handling, recall procedures, and investigation effectiveness.
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Pharmacovigilance (if applicable)
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Inspect adverse drug reaction reporting and regulatory compliance.
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