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Health Canada GPP Inspection Readiness Checklist

A working self-inspection against SOR/2018-144, built from the findings that actually get licence holders cited — not a generic template. Walk your site with it as if you were the inspector: anything you cannot evidence in under five minutes is a gap.

• Documents and records (ss.231-232) — master list, revisions, ALCOA, two-year retention
• The QAP — releases, complaints, alternate designation
• Premises, sanitation, and pest control (ss.81-87)
• Equipment and calibration (s.86) — including the daily balance check inspectors ask for
• Batch records and lot traceability — input lots that match COAs exactly
• Testing and COAs (ss.90-92) — including OOS handling
• Packaging and labelling (Part 7) — potency tolerance, symbol, warnings, net weight
• Complaints, returns, recall (s.46) — and the mock recall inspectors expect
• Deviations, CAPA, and training records
• Preventive Control Plan (ss.88.93-88.94) — the requirement most LPs miss
• Inventory control (s.224, CTLS) — reconciliation, variances, monthly reporting

Written by Chi Diem Doan, Ph.D. — practising QAP, zero critical findings across multiple Health Canada and EU-GMP audits.