SELF-INSPECTION IN PHARMA

Self-inspection in the pharmaceutical industry is a critical aspect of Good Manufacturing Practices (GMP) compliance. It involves an internal audit conducted by a pharmaceutical company to evaluate its processes, facilities, and systems to ensure they meet regulatory requirements and internal quality standards.

1. Self Inspection Checklist for HR
2. Self Inspection Checklist for Production
3. Self Inspection Checklist for Quality Assurance
4. Self Inspection Checklist for Quality Control
5. Self Inspection Checklist for Warehouse
6. SOP for Internal Quality Audit
7. Audit Checklist – Engineering
8. Audit Checklist – Validation
9. Audit Checklist – Warehouse
10. Audit Checklist – Water System
11. Audit Checklist – HR
12. Audit Checklist – HVAC
13. Audit Checklist – Packaging
14. Audit Checklist – QA
15. Audit Checklist – QC
16. Audit Checklist – Sterile Production
17. Audit Checklist – Tablets & Capsules

Self-inspection (internal audit) in pharma is a planned, systematic review performed by the company to check whether its operations comply with GMP and the Pharmaceutical Quality System (PQS), and to identify improvements before regulators or customers do. WHO notes that inspection guidance is also valuable for manufacturers when conducting self-inspection/internal audits. World Health Organization

Purpose

Self-inspections are performed to monitor implementation and compliance with GMP and to propose needed corrective measures. They also provide key inputs to management oversight—ICH Q10 includes self-assessment processes (including audits) as part of PQS monitoring and continual improvement. ICH Database

What it should cover

A self-inspection program typically examines (as applicable): personnel, premises, equipment, documentation, production, quality control, distribution, complaints/recalls, and the effectiveness of the overall quality system.

How to run an effective self-inspection

1. Plan a pre-arranged program (annual master schedule plus risk-based additions for high-risk areas like aseptic processing, data integrity, HVAC, water systems, cleaning validation, and laboratories).
2. Ensure independence and competence of auditors (trained auditors; not auditing their own work where possible; external experts may be useful).
3. Execute using checklists + process walk-throughs, interviews, and record sampling (BMR/BPR, logbooks, EM, deviations, OOS, calibration, cleaning, change control).
4. Document everything: observations, evidence, classification (critical/major/minor), and proposed actions. EU GMP requires that all self-inspections are recorded, with reports capturing observations and corrective measures, plus statements of actions taken.
5. CAPA and follow-up: assign owners/due dates, perform root cause analysis, verify effectiveness, and trend repeat findings.

A strong self-inspection culture makes the site “inspection-ready” by continuously closing gaps and strengthening GMP compliance.