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
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
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small regulatory authorities
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value to manufacturers
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assist in assessing GMP compliance self-inspection
Module 16 | Slide 4 of 8 January 2006
Inspection
Cover production and control
final dosage forms
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human and veterinary use
drug substances
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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
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through sequential examination (production and control)
recommend authorization of manufacture of pharmaceutical products
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verification of performance
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verification of data
Module 16 | Slide 8 of 8 January 2006