Regulatory Inspections
What the exam tests
You need to know who inspects what, on what trigger, against which standard, and what happens to the report. Expect questions on inspection type, observation severity, and the corrective and preventive action (CAPA) that must follow.
Who inspects what
- DRAP inspectors cover manufacturing sites, importers' warehouses and, for cause, products on the market; DRAP's GMP assessments feed licensing and export certification.
- Provincial inspectors cover sale premises - pharmacies, wholesalers, medical stores - for storage, personnel, records and licence compliance.
- Trial sites are inspected against GCP by the authority and audited separately by sponsors.
Types and sequence
Pre-licensing (before a licence or variation is granted), routine periodic (risk-based frequency by product risk, history and volume), for-cause (complaint, ADR cluster, recall, failed sample) and follow-up (verify CAPA). Sequence: notification or unannounced entry, opening meeting, facility walk, document and batch-record review, sampling where indicated, closing meeting, written report, response with CAPA and timelines, re-inspection.
Severity logic
Critical: direct risk of harm - mix-ups, falsified records, failed sterility assurance. Major: systemic GMP failure - no validation, no stability programme. Minor: documentation drift. Critical findings can trigger licence suspension, recall or a block on product release.
Worked example
An inspector finds two conflicting sets of batch records for the same batch. That is a data-integrity critical observation, not a clerical minor: quarantine the batch, trace distribution, and investigate the quality system that allowed it.
Traps
Answering 'CAPA' without a root cause; treating a failed sample as purely a laboratory problem; ignoring commitments made at the closing meeting; assuming unannounced inspections are unlawful.