Validation Part 5: Review and summary

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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

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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

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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

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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

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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

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Validation
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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

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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

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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