Transcript Basic Principles of GMP

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
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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
– assist in assessing GMP compliance
 value to manufacturers
– self-inspection
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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
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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
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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
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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