© WHO – PSM Validations – part 1 Workshop on GMP and Quality Assurance of TB products Kuala...
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© WHO – PSM Validations – part 1 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 1 Workshop on GMP and Quality Assurance of TB products Kuala...
© WHO – PSM
Validations – part 1
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
Part 1 Introduction and The Validation Master Plan
(VMP) Part 2: Validation principles
Part 3: Cleaning validation
Part 4: Process validation
Part 5: QC-related validation
Validation
© WHO – PSM
Objectives of Part 1 To provide an introduction to the subject
of Validation
To provide information on the Validation Master Plan
Validation
© WHO – PSM
Validation
Introduction
Three basic principles of Quality Assurance:
Quality, safety, effectiveness
Cannot inspect quality into a product
Processes must be under control
© WHO – PSM
Validation
WHO validation definition
The documented act of proving that any
procedure, process, equipment,
material, activity, or system actually
leads to the expected results.
© WHO – PSM
Qualification or validation?
A system must be qualified to operate in a validated process
Qualify a system and/or equipment
Validate a process Qualification versus validation, e.g. you
qualify an autoclave, whereas you validate a sterilization process
Validation
© WHO – PSM
Qualification and validation work require:
Collaboration of experts
Budget
Meticulous and careful planning
A Validation
Master Plan helps
the manufactur
er and inspectorat
e
Validation
© WHO – PSM
Validation
The Validation Master Plan
(VMP)
Philosophy
Content
Strategy
© WHO – PSM
Validation
Validation Master Plan Recommendation only Cover manufacturer’s validation policy and needs
Provides information on validation
organization
It should describe:
why?
what?
where?
by whom?
how?
when?
© WHO – PSM
Validation
Validation Master Plan
Prospective validation
Concurrent validation
Retrospective validation
Revalidation
Change control
© WHO – PSM
Validation
The VMP helps:
Management
Validation team members
Project leaders
GMP inspectors
© WHO – PSM
Validation
The VMP
Identifies validation items (products, processes, systems)
Defines nature and extent of testing
expected
Outlines test procedures and protocols
Summary document
Management agreement
© WHO – PSM
Validation Activities in VMP
Every validation activity included
Revalidation
Validation of new process cycles
Large validation projects have separate VMPs
Include reasonable unexpected events
Validation
© WHO – PSM
Validation
The VMP:
Enables overview of entire validation
project
Lists items to be validated with the planning schedule as its heart
Is like a map
© WHO – PSM
Validation
The “Introduction” to the VMP Validation policy
Project scope
Location and timing (including priorities)
Validation procedures
Standards
© WHO – PSM
Validation
VMP should state who is responsible for:
Preparing the VMP The protocols and SOPs Validation work Report and document preparation and control Approval/authorisation of validation protocols
and reports in all stages of validation process Tracking system Training needs in support of validation
© WHO – PSM
Validation
VMP should contain: Cross references to documents
Specific process considerations
Specific characteristics briefly outlined
Validation list (What to validate)
premises, systems and equipment processes products
© WHO – PSM
Validation
VMP should contain: Descriptions of
plant (where to validate) processes products
Personnel attributes expertise and training
Key acceptance criteria
© WHO – PSM
VMP should contain: Format for protocols and other
documentation List of relevant SOPs (How) Planning and scheduling (When) Location (Where) Estimate of staffing requirements (Who) A time plan of the project (When) Annexes
Validation
© WHO – PSM
Validation
VMP should contain change control
Policy and procedure
Risk assessment
Authorization
Failure to properly document changes to the
system means invalidation of the process
© WHO – PSM
Validation
Changes that require revalidation Software changes; Controllers
Site changes; Operational changes
Change of source of material
Change in the process
Significant equipment change
Production area changes
Support system changes
© WHO – PSM
Validation
In summary, a VMP should contain atleast: Validation policy Organizational structure Summary of facilities, systems, equipment,
processes to be validated Documentation format for protocols and
reports Planning and scheduling Change control Training requirements
© WHO – PSM
Validation
Question no 14
The equipment has to be __________ before validating the process which uses the equipment.
© WHO – PSM
Validation
Question no 28
Which document explains the validation policy of the company?
