© 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: hietavam@who.int

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