SOP: Self-Inspection (Internal GMP Audit)

 

1. Purpose

To define the procedure for planning, conducting, reporting, and following up self-inspections to verify compliance with GMP/GDP, internal procedures, and regulatory requirements; to identify improvements and prevent recurrence of non-conformities.

2. Scope

Applies to all GMP-relevant areas and activities at [Company/Site]: Production, QC, QA, Warehouse, Engineering/Utilities, Validation, Microbiology, Maintenance, Calibration, IT/CSV, Safety & Hygiene, Contracted operations, and Supporting services.

3. References

  • WHO TRS 986 Annex 2 / EU GMP Part I Ch. 9 (Self-inspection)

  • ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System)

  • Company QMS documents (Change Control, Deviation, CAPA, Training, Document Control)

4. Definitions

  • Observation grading:
    Critical: Potential patient safety/legal impact; significant GMP breach.
    Major: Could affect product quality/compliance; systemic failure.
    Minor: Isolated lapse with low risk.

  • CAPA: Corrective and Preventive Action.

5. Responsibilities

  • QA Head (Process Owner): Approves annual plan, auditor qualification, final reports; monitors CAPA closure & effectiveness.

  • Lead Auditor (QA or trained cross-functional): Plans, conducts audits, issues report, verifies corrections.

  • Auditee HODs: Ensure access, provide records, own CAPA and timely closure.

  • Auditors (Team): Perform interviews, review records, record objective evidence.

  • Training: Ensures auditors maintain competency records.

6. Auditor Qualification & Independence

  • Trained in GMP, auditing techniques, risk grading, data integrity.

  • Not auditing their own routine work area (independence).

  • Qualification records maintained by QA.

7. Frequency & Planning

  • Minimum: Each GMP area at least once per year.

  • Risk-based frequency: Up to quarterly for high-risk areas (e.g., aseptic ops, water systems, complaints/recalls, data integrity).

  • Prepare Annual Self-Inspection Plan (areas, dates, auditors). Revisions controlled through change control.

8. Audit Preparation

  1. Review previous reports, open CAPAs, changes, OOS/OOT, deviations, complaints/recalls, regulatory commitments.

  2. Prepare Audit Checklist aligned to area (Production, QC, Warehouse, Utilities, DI/ALCOA+).

  3. Notify auditees (scope, date, team) ≥5 working days in advance (unannounced allowed by QA for cause).

  4. Arrange PPE, access permits, and sampling tools if required.

9. Conduct of Self-Inspection

9.1 Opening Meeting

  • Confirm scope, criteria, schedule, safety rules, document access, photo policy, confidentiality.

9.2 On-site Activities

  • Gemba walk: Observe flows (personnel, material, waste), line clearance, housekeeping (5S), segregation, environmental control.

  • Interviews: With operators, supervisors, analysts; verify training & understanding of procedures.

  • Record review: BMR/BPRs, logbooks, e-records/audit trails, calibration & qualification, cleaning & sanitation, deviations, change controls, validations, COAs, data backup/restore.

  • Sampling of records: Risk-based; at least last 10 lots or last 3 months, whichever larger (adapt per area).

  • Data Integrity (ALCOA+): Check contemporaneity, attributable signatures, controlled copies, electronic audit trails, access controls.

  • Traceability test (where applicable): From raw material receipt → batch disposition or reverse.

  • Utilities check: Water system, HVAC, compressed air—parameters vs. limits; recent OOC/alerts and actions.

9.3 Evidence & Observation Recording

  • Record objective evidence (document ID, equipment tag, batch no., photo ID where allowed).

  • Classify Critical/Major/Minor with rationale and risk statement.

  • Discuss in-process corrections where possible (without disturbing operations).

9.4 Closing Meeting

  • Present observations with grades and examples; agree on responsible person and target dates for each CAPA; note any immediate containment actions.

10. Reporting

  • Issue Self-Inspection Report within 5 working days (Critical: same day notification to QA Head/Management).

  • Report content: scope, team, dates, areas covered, summary of previous CAPAs status, detailed observations (grade, evidence, requirement breached), risk assessment, agreed actions & due dates, photographs (if permitted), annexed checklist & attendance.

11. CAPA Management

  • CAPA plan due from auditee within 10 working days (Critical: 48 hours).

  • CAPA must include: root cause (5-Why/Fishbone), corrections vs. corrective vs. preventive actions, owner, due date, effectiveness criteria, and risk mitigation.

  • CAPA linkage to change control, revalidation, retraining, document revisions as needed.

12. Timelines for Closure (default)

  • Critical: Containment immediate; CAPA complete ≤30 days.

  • Major: ≤45 days.

  • Minor: ≤60 days.
    (Adjust per company policy/regulation; extensions via QA approval with justification.)

13. Effectiveness Verification

  • Lead auditor/QA verifies implemented CAPAs against defined effectiveness measures after 30–90 days or next audit cycle.

  • Methods: targeted re-audit, KPI trend review (deviations, OOS, complaints), sample record checks.

14. Escalation & Management Review

  • Repeated/uncleared Critical/Major → escalation to Site Head; possible batch impact assessment and regulatory notification per recall/field alert SOPs.

  • Include self-inspection metrics & trends in Management Review: number by area & grade, closure on time %, repeat observations %, DI findings, top 5 root causes.

15. Documentation & Records (retention ≥ 5 years)

  • Annual plan, checklists, attendance, raw notes, reports, CAPA plans, closure evidence, effectiveness reviews, auditor training/qualification records.

16. Data Integrity & Confidentiality

  • Handle records per document control; no alteration of original entries.

  • Photos/screenshots only as permitted; store securely with access control.

17. Health, Safety & GMP Etiquette

  • Follow gowning flows, PPE, and entry restrictions. Do not obstruct operations. Sanitize hands/equipment before entry to controlled areas.

18. Attachments / Templates (Annexes)

  • Annex 1: Annual Self-Inspection Plan (matrix by month vs. area).

  • Annex 2: Area-wise Audit Checklists (Production/QC/Warehouse/Utilities/DI).

  • Annex 3: Observation Report & Grading Sheet.

  • Annex 4: CAPA Plan Template with root-cause form.

  • Annex 5: Auditor Qualification & Training Matrix.

  • Annex 6: Attendance & Opening/Closing Meeting Minutes.

Comments

Post a Comment