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Good Practices for Quality Control Laboratories

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Good Manufacturing Practice Good Practices for Quality Control Laboratories WHO Training material amended by Dr. AJ van Zyl for the training workshop in – PowerPoint PPT presentation

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Title: Good Practices for Quality Control Laboratories


1
Supplementary Training Modules on Good
Manufacturing Practice
Good Practices for Quality Control
Laboratories WHO Training material amended by
Dr. AJ van Zyl for the training workshop in Dar
Es Salaam, Tanzania, August 2006
WHO Technical Report Series, No. 902, 2002.
Annex 3
2
Quality Control
  • Introduction
  • This QC training module consists of 4 parts
  • Part 1 Management and organization
  • Part 2 Materials, equipment, instruments and
    devices
  • Part 3 Working procedures and documents, and
    safety in the laboratory
  • Part 4 Inspecting the laboratory

Part One.
3
Quality Control
  • Objectives
  • To discuss Good Practices for Quality Control
    laboratories including quality systems and
    infrastructure
  • To understand the role and importance of the
    Quality Control laboratory in
  • Sampling and testing
  • Materials, equipment and systems
  • To discuss approaches in inspecting a Quality
    Control laboratory

Part One
4
Quality Control
Part One. Management and infrastructure 1.
Organization and management 2. Quality system 3.
Control of documentation 4. Records 5. Data
processing equipment 6. Personnel 7. Premises 8.
Equipment, instruments and other devices
5
Quality Control
Part Two. Materials and set-up of equipment,
instruments and other devices 9. Specifications
archive 10. Reagents 11. Reference materials 12.
Calibration, validation and verification of
equipment, instruments and other devices 13.
Traceability
6
Quality Control
Part Three. Working procedures 14. Incoming
sample 15. Analytical worksheet 16. Testing 17.
Evaluation of test results 18. Retained
samples Part Four. Safety in pharmaceutical
control laboratories 19. General rules
7
Quality Control
  • Background
  • Recommendations relevant to quality control
    testing at the site of the pharmaceutical
    manufacturer
  • Laboratory provides a service - like a
    manufacturing unit
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