GMP Inspection Process

1. GMP Inspection Process Introduction

2. Introduction Programme Objectives 1. Training in the WHO GMP text on inspection 2. Training in using your experience 3. Developing your own action plan

3. Inspection Programme Overview • Introduction • The fundamentals of inspection • the role of the inspector • preparing for inspections • the inspection process • Types of inspection

4. Introduction • Guidelines • to promote harmonization • directed to government inspectors • small regulatory authorities • assist in assessing GMP compliance • value to manufacturers • self-inspection

5. Inspection • Cover production and control • final dosage forms • human and veterinary use • drug substances • API and bulk drug substances • Same fundamental principles • pharmaceutical products • biological products • medical devices • diagnostic products

6. Inspection • Inspection and licensing • vital element of drug control • WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce

7. Inspection • Other contexts • self-inspection of the company • independent inspection by persons from, e.g. International Organization for Standardization (ISO) • audit by authorized agents of a customer

8. Inspection • Inspectorate • enforcement arm of the national drug regulatory authority (DRA) • Functions • ensure adherence to licensing provisions • adherence to GMP • Objectives • control and enforce standards • through sequential examination (production and control) • recommend authorization of manufacture of pharmaceutical products • verification of performance • verification of data