© WHO – PSM Validations –part 2 Workshop on GMP and Quality Assurance of TB products Kuala...
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© WHO – PSM Validations –part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster Tel: +41.22.791.3598 Fax: +41.22.791.4730 World Health Organization E-mail: [email protected] Supplementary Training modules on Good Manufacturing Practices
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Transcript of © WHO – PSM Validations –part 2 Workshop on GMP and Quality Assurance of TB products Kuala...
© WHO – PSM
Validations –part 2
Workshop onGMP and Quality Assurance of TB products
Kuala LumpurMalaysia, 21 – 25 February 2005
Maija Hietava M.Sci.Pharm
Quality Assurance and Safety: Medicines, Medicines Policy and Standards, Health Technology and Pharmaceuticals Cluster
Tel: +41.22.791.3598 Fax: +41.22.791.4730World Health Organization
E-mail: [email protected]
Supplementary Training modules on Good Manufacturing Practices
© WHO – PSM
Objectives
To review:
WHO validation definition
Philosophy of validation
Personnel requirements
Protocol requirements
DQ IQ OQ and PQ summary
Checklist for validation
Validation principles
© WHO – PSM
WHO validation definition
The documented act of proving that any procedure, process, equipment,
material, activity or system actually leads to the expected results.
Validation
© WHO – PSM
The VMP
The VMP provides a summary of the company’s philosophy, policy, intentions
and approach to validation.
Validation
© WHO – PSM
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
© WHO – PSM
Quality is designed and built
into the
process/method/premises
Functionality, consistency and repeatability
is confirmed by
validation
Validation
© WHO – PSM
Validation as such
does not improve the process
but it
Confirms and assures that the process
•Has been well developed
•It is well maintained
•It operates as it should
Validation
© WHO – PSM
Advantages of validation:•During the process the knowledge of process increases
•Assures the repeatability of the process
•Assures the fluency of production
•Assures that the product is continuously according to the marketing authorisation
•Decreases the risk of the manufacturing problems
•Decreases the expenses caused by the failures in production
•Decreases the risks of failing in GMP
•Decreases the expenses of the every day production even though the validation itself will create expenses
Validation
© WHO – PSM
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
© WHO – PSM
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
© WHO – PSM
WBS/Validation of new premises
VALIDATIONVALIDATION
Clean areaPremises
ManufacturingProcesses
EquipmentManufacturing Support Syst.
UtilitySystems
AnalyticalMethods
PersonnelTraining
AsepticProcessing
In-ProcessControl
- HVAC System- LAF Units- Cold Storage- Env. Monitoring- Facility Cleaning- Transfer hatches- Verifi. of classific.
- Water systems- Plant Steam- Pure/Clean Steam- Process Gases
- Sterilizers- Depyrogenators- SIP Systems- CIP Systems- Washing - Waste Systems
- Fermentors- Scales- Incubators- Filtration Units- Filling Equipment- Computerised systems
- Fermentation- Separation- Purification- Filtration- Filling
Packaging & Labeling
- Media Fills - Packaging- Labeling
- Process Measurem.- Visual Inspection- Label Control - Sampling
- GMP- Gpwning valid..- SOPs- Equipment- Processes
- Chemical - Cleaning valid- Physical - Sterility tests- Biological - Stability
© WHO – PSM
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
© WHO – PSM
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
© WHO – PSM
DQ IQ OQ PQ
Certification
GMP Processunder control
Reviewperiodically
TrainingCalibration
Changecontrol
ValidationValidation
© WHO – PSM
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
© WHO – PSM
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
© WHO – PSM
Summary Validation A quality tool that makes lot of sense A prevention-based activity= important part of
quality building process Expensive in the beginning later will "save the
money back" In danger of becoming overwhelming Risk-based assessment of what needs to be
validated or verified The process must be under control/validation as
such does not improve the process Logical entity: protocol + procedure +
report
Validation
© WHO – PSM
Question no 29-31
What are the three important parameters confirmed by validation?
Validation
