Module 16 | Slide 1 of 8 January 2006 GMP Inspection Process Introduction.
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Transcript of Module 16 | Slide 1 of 8 January 2006 GMP Inspection Process Introduction.
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