qualification and validation of cleanrooms in the pharmaceutical industry

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

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)

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

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

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)

Scope
 Premises
 Equipment
have been built and installed in accordance with their design
specifications
 Also referred to as Installation Qualification (IQ)
4.3(b)

Scope
 Equipment
operate in accordance with their design specifications
 Also referred to as Operational Qualification (OQ)
4.3(c)

Scope
 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)

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)

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

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

Types of Documentation
 Validation Master Plan (VMP)
 Validation protocols
 Validation reports
 Standard Operating Procedures (SOPs)

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

Importance:
 Premises, utilities, equipment and processes
 Critical importance and particular attention paid to validation of:
 Analytical test methods
 Automated systems
 Cleaning procedures
4.11

Basic Principles of GMP
 What are the qualification
and validation requirements
here for this piece of
equipment, as well as the step
in production?

Annex 6
WHO References
 Good manufacturing practices (GMP): guidelines on the validation
of manufacturing processes
 Validation of analytical procedures used in the examination of
pharmaceutical materials

Example of priorities for process validation
Type of process Requirement
 New Every new process before approval for routine
 Existing:
 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)

 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…

 A qualification or validation protocol may contain:
 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)

 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.

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?

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?

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

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

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

Possible situation – II
 New product introduced into an existing tablet manufacturing
site, with 20 products already being produced
 Process Cleaning
 Training

Possible situation – III
 A new liquids manufacturing building on an existing site which will
produce 2 products
 Ventilation
 Cleaning
 Training

Possible situation – IV
 An existing sterile suite producing 5 products that are terminally
sterilized
 Sterilizers
 Ventilation and other environmental aspects
 Cleaning
 Training

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