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