Validation part 5 review and summary
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Supplementary Training Modules on Good Manufacturing Practice. Validation Part 5: Review and summary. 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 part 5 review and summary l.jpg

Supplementary Training Modules on Good Manufacturing Practice

Validation Part 5: Review and summary


Validation l.jpg
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.


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Validation

The VMP

  • The VMP provides a summary of the company’s philosophy, policy, intentions and approach to validation.


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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


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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

GMP Inspector’s 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 Inspector’s 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 toolthat 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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