Module 16 | Slide 1 of 8 January 2006

GMP Inspection ProcessGMP Inspection Process

Introduction

Module 16 | Slide 2 of 8 January 2006

IntroductionIntroduction

Programme Objectives

1. Training in the WHO GMP text on inspection

2. Training in using your experience

3. Developing your own action plan

Module 16 | Slide 3 of 8 January 2006

InspectionInspection

Programme Overview

Introduction

The fundamentals of inspection

the role of the inspector

preparing for inspections

the inspection process

Types of inspection

Module 16 | Slide 4 of 8 January 2006

IntroductionIntroduction

Guidelines to promote harmonization directed to government inspectors

– small regulatory authorities– assist in assessing GMP compliance

value to manufacturers– self-inspection

Module 16 | Slide 5 of 8 January 2006

InspectionInspection

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

Module 16 | Slide 6 of 8 January 2006

InspectionInspection

Inspection and licensing vital element of drug control WHO Certification Scheme on the Quality of

Pharmaceutical Products moving in International Commerce

Module 16 | Slide 7 of 8 January 2006

InspectionInspection

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

Module 16 | Slide 8 of 8 January 2006

InspectionInspection

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