SOP-026 / 1.0
Self-audit and quality-system review
Nonsterile laboratory system: documents, personnel, premises, equipment, materials, compounding, QC and handover.
Procedure
- The responsible pharmacist approves an annual self-audit plan; subject frequency follows risk, previous findings and changes.
- Appoint a competent reviewer sufficiently independent of the audited activity and record independence limitations in a small team.
- Sample actual batches and trace order, F-002 version, materials, weights, QC, BUD, label and recipient.
- Inspect actual conditions, pre-use checks, cleaning, training, sources and record access/restoration. Record specific evidence in F-020.
- Prioritise findings by impact. A critical finding needs immediate containment and batch assessment; other actions have an owner and deadline.
- Verify CAPA effectiveness and document trend review. Self-audit does not replace competent-authority inspection or constitute GMP certification.
Stop criterion
Uncontrolled critical finding: suspend the affected activity until a documented decision.
Related forms
Sources and references
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-10-14
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 4–9Risk, personnel, facilities and QA; its historical BUD table is not used for current USP defaults2026-10-14
- NAPRA — Guidance Document for Pharmacy Compounding of Non-sterile PreparationsMarch 2018, clarification January 2022Sections 5, 6 and 7; master/batch records, delivery, qualityQuality-system implementation; historical BUD table not substituted for 2022 USP revision2026-10-14