GMP Inspection Process

Introduction

Module 16 | Slide 1 of 8 January 2006

Introduction

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 2 of 8 January 2006

Inspection

Programme Overview

 Introduction  The fundamentals of inspection 

the role of the inspector



preparing for inspections



the inspection process

 Types of inspection

Module 16 | Slide 3 of 8 January 2006

Introduction

 Guidelines 

to promote harmonization



directed to government inspectors

–

small regulatory authorities

– 

value to manufacturers

–

assist in assessing GMP compliance self-inspection

Module 16 | Slide 4 of 8 January 2006

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

Module 16 | Slide 5 of 8 January 2006

Inspection

 Inspection and licensing 

vital element of drug control



WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce

Module 16 | Slide 6 of 8 January 2006

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

Module 16 | Slide 7 of 8 January 2006

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

Module 16 | Slide 8 of 8 January 2006