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Module 1,, Part 5: Review and summary Slide 1 of 13
© WHO – EDM
Validation Part 5:
Review and summary
Supplementary Training Modules on Good Manufacturing Practice
Module 1,, Part 5: Review and summary Slide 2 of 13
© WHO – EDM
Objectives
To review:
WHO validation definition
Philosophy of validation
Personnel requirements
Protocol requirements
DQ IQ OQ and PQ summary
Checklist for validation
Validation
Module 1,, Part 5: Review and summary Slide 3 of 13
© WHO – EDM
WHO validation definition
The documented act of proving that any procedure, process, equipment,
material, activity or system actually leads to the expected results.
Validation
Module 1,, Part 5: Review and summary Slide 4 of 13
© WHO – EDM
The VMP
The VMP provides a summary of the company’s philosophy, policy, intentions
and approach to validation.
Validation
Module 1,, Part 5: Review and summary Slide 5 of 13
© WHO – EDM
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
Validation
Module 1,, Part 5: Review and summary Slide 6 of 13
© WHO – EDM
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
Validation
Module 1,, Part 5: Review and summary Slide 7 of 13
© WHO – EDM
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
Module 1,, Part 5: Review and summary Slide 8 of 13
© WHO – EDM
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
Module 1,, Part 5: Review and summary Slide 9 of 13
© WHO – EDM
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
Module 1,, Part 5: Review and summary Slide 10 of 13
© WHO – EDM
DQ IQ OQ PQ
Certification
GMP Processunder control
Reviewperiodically
TrainingCalibration
Changecontrol
ValidationValidation
Module 1,, Part 5: Review and summary Slide 11 of 13
© WHO – EDM
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
Validation
Module 1,, Part 5: Review and summary Slide 12 of 13
© WHO – EDM
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
Validation
Module 1,, Part 5: Review and summary Slide 13 of 13
© WHO – EDM
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
Validation
