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Quality and Good Manufacturing Practices

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Quality and Good Manufacturing Practices 6 November 2007 Jiaxing, People's Republic of China Quality and Good Manufacturing Practices GMP: Validation Presented by: Dr ... – PowerPoint PPT presentation

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Title: Quality and Good Manufacturing Practices


1
Quality and Good Manufacturing Practices
  • Quality and Good Manufacturing Practices
  • 6 November 2007
  • Jiaxing, People's Republic of China

2
Quality and Good Manufacturing Practices
  • GMP
  • Validation
  • Presented by Dr A J van Zyl
  • Technical Officer WHO
  • HTP/PSM/QSM
  • vanzyla_at_who.int

3
Quality and Good Manufacturing Practices
  • Outline and Objectives of presentation
  • Discuss key aspects of GMP in relation to
  • Validation

4
Norms and standards
  • Printed in respective TRS and WHO web site
  • General recommendations in the main text
  • Additional text published TRS 937

5
Validation
  • Part 1. General overview on qualification and
    validation
  • Part 2. Qualification of HVAC and water systems
  • Part 3. Cleaning validation
  • Part 4. Analytical method validation
  • Part 5. Computerized system validation
  • Part 6. Qualification of systems and equipment
  • Part 7. Non sterile product process validation

6
Validation
  • Introduction
  • Validation is an essential part of GMP, and an
    element of QA
  • Basic principles include
  • Safety, quality and efficacy of products
  • Built into the product
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