Transcript Basic Principles of GMP Qualification and Validation Section 4 Module 4 | Slide 1 of 28 January 2006

Basic Principles of GMP
Qualification and
Validation
Section 4
Module 4
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Slide 1 of 28
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Qualification and Validation
Objectives
 To review basic aspects of qualification and validation
 To understand the scope of qualification and validation
 Introduction to documentation associated with validation
(See also Supplementary Training Module on Validation)
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Qualification and Validation
Definitions
Validation
 Action of proving, in accordance with the principles of GMP, that any
procedure, process, equipment, material, activity or system actually
leads to the expected results
Qualification
 Action of proving that any premises, systems and items of
equipment work correctly and actually lead to the expected results
(Validation usually incorporates the concept of qualification)
Glossary
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Qualification and Validation
Principle
 Essential part of GMP
 Manufacturer to identify what qualification and validation work is
required
 Prove that critical aspects of work are controlled
 Key elements of qualification and validation defined and
documented
4.1, 4.2, 4.8
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Qualification and Validation
Scope
 Documented evidence to prove that, e.g.
 Premises
 Supporting utilities
 Equipment
have been designed in accordance with GMP
 Also referred to as Design Qualification (DQ) where appropriate
4.3(a)
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Qualification and Validation
Scope
 Documented evidence to prove that, e.g.
 Premises
 Supporting utilities
 Equipment
have been built and installed in accordance with their design
specifications
 Also referred to as Installation Qualification (IQ)
4.3(b)
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Qualification and Validation
Scope
 Documented evidence to prove that, e.g.
 Supporting utilities
 Equipment
operate in accordance with their design specifications
 Also referred to as Operational Qualification (OQ)
4.3(c)
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Qualification and Validation
Scope
 Documented evidence to prove that, e.g.
 Supporting utilities
 Equipment
perform consistently in accordance with their design
specifications – see also next slide on PV
 Also referred to as Performance Qualification (OQ)
4.3(d)
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Qualification and Validation
Scope
 Documented evidence to prove that:
 A specific process will consistently produce a product meeting
its predetermined specifications and quality attributes
 Also referred to as Process Validation (PV)
4.3(d)
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Qualification and Validation
Scope
Qualification and validation:
 Applicable to any aspect of operation which may affect the quality of
the product
 Directly or indirectly
 Includes premises, facilities (utilities), equipment, processes
 Includes significant changes
4.4
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Qualification and Validation
Principle
 Qualification and validation should be done in accordance with an
ongoing programme
 Initial qualification and validation
 Annual review
 Maintain continued validation status
 Policy described in relevant documentation, e.g. quality manual, or
Validation Master Plan
4.5, 4.6
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Qualification and Validation
Types of Documentation
 Validation Master Plan (VMP)
 Validation protocols
 Validation reports
 Standard Operating Procedures (SOPs)
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Qualification and Validation
Documentation
 Clearly defines responsibility of performing validation
 Conducted in accordance with predefined, approved validation
protocols
 Recorded results and conclusions presented in written validation
reports – prepared and stored
 Processes and procedures should be established on the basis of
these results
4.7 – 4.10
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Qualification and Validation
Importance:
 Premises, utilities, equipment and processes
 Critical importance and particular attention paid to validation of:
 Analytical test methods
 Automated systems
 Cleaning procedures
4.11
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Basic Principles of GMP
 What are the qualification
and validation requirements
here for this piece of
equipment, as well as the step
in production?
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Qualification and Validation
WHO References
 Good manufacturing practices (GMP): guidelines on the validation
of manufacturing processes
 Validation of analytical procedures used in the examination of
pharmaceutical materials
Annex 6
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Qualification and Validation
Example of priorities for process validation
Type of process
Requirement
 New
 Existing:
Every new process before approval for routine
 Sterile products
All processes affecting the sterility, and
manufacturing environment including
sterilization stage
 Non-sterile
Low dose tablets and capsules: mixing and
granulation; content uniformity (and other
parameters)
Other tablets and capsules: uniformity of mass
(and other parameters)
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Qualification and Validation
 The Validation Master Plan may contain elements (and policy) such
as:
 Approval page and table of contents
 Introduction and objectives
 Facility and process description
 Personnel, planning and scheduling
 Responsibilities of validation team members
 Process control aspects
 Equipment, apparatus, processes and systems qualified,
validated – and to be qualified or validated
 Acceptance criteria
 Documentation, e.g.validation protocols and reports
 SOPs
 Training requirements and other elements…
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Qualification and Validation
 A qualification or validation protocol may contain:
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Objectives of the validation and qualification study
Site of the study
Responsible personnel
Description of the equipment
SOPs
Standards
Criteria for the relevant products and processes
(See WHO formats (handouts) as part of training material)
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Qualification and Validation
 A qualification or validation report should reflect the elements of
the protocol, and may contain elements such as:
 Title
 Objective of the study
 Reference to the protocol
 Details of materials, equipment, instruments, personnel
 Programmes and cycles used
 Details of procedure and test methods
… etc.
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Qualification and Validation
Group Session 1: Option 1
 From your experience of factory inspections, what progress has
been made in introducing validation in your country?
 What are the major obstacles and how can they be overcome?
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Qualification and Validation
Group Session 1: Option 2
 List some documents related to validation, that you expect to find at
a manufacturing site
 Identify aspects in each document that you would evaluate or
assess
 What problems do you anticipate the company faced when it
prepared these documents?
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Qualification and Validation
Possible Issues
 Lack of time
 Lack of personnel
 Lack of experience and knowledge
 Changes to the process
 Prospective versus retrospective validation
 Lack of documentation infrastructure
 Lack of implementation of validation
 Poorly designed documents
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Qualification and Validation
Group Session 2
 List the aspects that you will evaluate when assessing the validation
for the project that your group has been given
 Identify the critical parameters that should have been evaluated by
the manufacturer
 List the tests to be carried out and comment on the acceptance
criteria to be set
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Qualification and Validation
Possible situation – I
 Refurbishment of a liquids department, producing a single product
on an established site with an existing purified water system
 Ventilation system
 Equipment and process
 Training
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Qualification and Validation
Possible situation – II
 New product introduced into an existing tablet manufacturing
site, with 20 products already being produced
 Process Cleaning
 Training
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Qualification and Validation
Possible situation – III
 A new liquids manufacturing building on an existing site which will
produce 2 products
 Ventilation
 Equipment and process
 Cleaning
 Training
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Qualification and Validation
Possible situation – IV
 An existing sterile suite producing 5 products that are terminally
sterilized
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Sterilizers
Ventilation and other environmental aspects
Equipment and process
Cleaning
Training
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