As a pharmaceutical buyer or distributor, conducting a WHO-GMP-aligned audit of a prospective Deferasirox manufacturer is standard diligence. This post outlines what to expect.
1. Audit Scope #
A customer audit typically covers: Pharmaceutical Quality System, personnel, premises & equipment, documentation, production, quality control, materials management, and complaint / recall procedures.
2. Pre-Audit Preparation #
- Sign CDA with manufacturer
- Share audit scope and agenda in advance (usually 2-4 weeks ahead)
- Request advance documents: site master file, GMP certificate, organogram, SOP list
3. Typical Agenda (2-day audit) #
| Day / Session | Activity |
|---|---|
| Opening meeting | Scope confirmation, team introductions |
| Site tour | Production areas, QC laboratory, warehousing |
| Quality system review | PQS, deviations, CAPA, change control, APQR |
| Production review | Batch records, IPC, line clearance, equipment qualification |
| QC review | Methods, validation, OOS handling, stability |
| Materials review | Supplier qualification, sampling, warehousing |
| Closing meeting | Findings, classification, next steps |
4. Documents to Review #
- Site Master File
- Recent Self-Inspection report
- Deviation trending (last 12 months)
- APQR for the relevant product
- Training records
- Validation master plan
- Complaint log
5. Finding Classification #
- Critical - immediate patient risk or major system failure
- Major - significant deviation from GMP
- Minor - localised, non-systemic issue
- Observations - improvement opportunities
6. Post-Audit #
A written audit report with findings is shared typically within 2-4 weeks. The manufacturer responds with a CAPA plan, to be closed within agreed timeframes. CAPA closure evidence is shared with the auditing customer.
Taj Pharma hosts customer audits regularly - see WHO-GMP Compliance.