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Validation Part 5: Review and summary

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WHO validation definition. Philosophy of validation. Personnel requirements. Protocol requirements ... Definition of non-conformance. Statistical methods ... – PowerPoint PPT presentation

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Title: Validation Part 5: Review and summary


1
Validation Part 5 Review and summary
Supplementary Training Modules on Good
Manufacturing Practice
2
Validation
  • Objectives
  • To review
  • WHO validation definition
  • Philosophy of validation
  • Personnel requirements
  • Protocol requirements
  • DQ IQ OQ and PQ summary
  • Checklist for validation

3
Validation
  • WHO validation definition
  • The documented act of proving that any
    procedure, process, equipment, material,
    activity or system actually leads to the
    expected results.

4
Validation
  • The VMP
  • The VMP provides a summary of the companys
    philosophy, policy, intentions and approach to
    validation.

5
Validation
  • The WHO GMP Guidelines state
  • Validation studies are an essential part of good
    manufacturing practice and should be conducted in
    accordance with predefined protocols.
  • written report and conclusion
  • process and procedures
  • processing
  • testing
  • cleaning procedures

6
Validation
  • Personnel - Validation team members
  • Quality Assurance
  • Engineering
  • Manufacturing
  • Other disciplines may be involved depending on
    the product and process
  • laboratory, technical services
  • research and development, regulatory affairs
  • clinical
  • chemical engineering
  • purchasing/planning

7
Validation
  • Protocol development (1)
  • Identification of process
  • Objective and measurable criteria
  • Length and duration of the validation
  • Shifts, equipment
  • Identification and quality of utilities
  • Identification of operators and operator training
    and qualification

8
Validation
  • Protocol development (2)
  • Complete description of the process
  • Relevant specifications and tests
  • Samples and sampling methods
  • Special controls or conditions
  • Process parameters to be monitored
  • Methods for controlling and monitoring

9
Validation
  • Protocol development (3)
  • Objective and subjective criteria used to
    evaluate the product
  • Definition of non-conformance
  • Statistical methods
  • Maintenance and repairs
  • Criteria for revalidation
  • Criteria for change control

10
Validation
11
Validation
  • GMP Inspectors check list for validation (1)
  • Check that the manufacturer has
  • A VMP and multi-functional team for validation
  • Planned approach , defined requirements
  • Identified and described processes
  • Analyse the amount of validation work to perform

12
Validation
  • GMP Inspectors check list for validation (2)
  • Check that the manufacturer has
  • Selected methods and tools for validation
  • Created protocols
  • Performed DQ, IQ, OQ, PQ and documented results
  • Exerted change control, set revalidation time

13
Validation
  • Summary
  • Validation
  • A quality tool that makes sense
  • A prevention-based activity
  • Expensive
  • In danger of becoming overwhelming
  • Risk-based assessment of what needs to be
    validated or verified
  • The process must be under control
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