Module 4Slide 1 of 23 WHO - EDM Validation Basic Principles of GMP.
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Transcript of Module 4Slide 1 of 23 WHO - EDM Validation Basic Principles of GMP.
Module 4 Slide 1 of 23 WHO - EDM
Validation
Basic Principles of GMP
Module 4 Slide 2 of 23 WHO - EDM
Validation
Objectives
To review the definition and types of validation
To understand the requirements for documentation and key stages in the process of validation
To consider models for process validation
Module 4 Slide 3 of 23 WHO - EDM
Validation
Definition
Validation is the documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result
Module 4 Slide 4 of 23 WHO - EDM
Validation
Essential Part of GMP Predetermined protocols
Written reports
Processes and procedures
Periodic revalidation
Specific attention: processing testing cleaning
Module 4 Slide 5 of 23 WHO - EDM
Annex 6
Validation
WHO References
Good manufacturing practices: guidelines on the validation of manufacturing processes
Validation of analytical procedures used in the examination of pharmaceutical materials
Module 4 Slide 6 of 23 WHO - EDM
Validation
Types of Process Validation Experimental approach
Prospective validation Concurrent validation
Analysis of historical data Retrospective validation
Revalidation Periodic revalidation Revalidation after change
Module 4 Slide 7 of 23 WHO - EDM
Validation
Stages of Validation
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Module 4 Slide 8 of 23 WHO - EDM
Validation
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)
Module 4 Slide 9 of 23 WHO - EDM
Validation
Types of Documentation
Validation Master Plan (VMP)
Validation protocols (VP)
Validation reports (VR)
Standard Operating Procedures (SOPs)
Module 4 Slide 10 of 23 WHO - EDM
Validation The Validation Master Plan could consist of:
Approval page and table of contents Introduction and objectives Facility and process description Personnel, planning and scheduling Responsibilities of committee members Process control aspects Equipment, apparatus, processes and systems to be
validated Acceptance criteria Documentation e.g.validation protocols and reports SOPs Training requirements
Module 4 Slide 11 of 23 WHO - EDM
Validation Protocol
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
Module 4 Slide 12 of 23 WHO - EDM
Validation Report
Title Objective of the study Refer to the protocol Details of material Equipment Programmes and cycles use Details of procedure and test methods
Module 4 Slide 13 of 23 WHO - EDM
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?
Module 4 Slide 14 of 23 WHO - EDM
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 to have faced when the company drafted these documents?
Module 4 Slide 15 of 23 WHO - EDM
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
Module 4 Slide 16 of 23 WHO - EDM
Validation
WHO Model for
Validation Protocol and Report - I
Part 1 – Purpose and prerequisites
Part 2 – Presentation of the process
Part 3 – Validation protocol
Module 4 Slide 17 of 23 WHO - EDM
Validation
WHO Model for
Validation Protocol and Report - II
Part 4 – Installation qualification
Part 5 – Qualification protocol/report
Part 6 – Product characteristics
Module 4 Slide 18 of 23 WHO - EDM
Validation
WHO Model for
Validation Protocol and Report - III
Part 7 – Evaluation
Part 8 – Certification
Part 9 – Summary
Module 4 Slide 19 of 23 WHO - EDM
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.
Module 4 Slide 20 of 23 WHO - EDM
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
Module 4 Slide 21 of 23 WHO - EDM
Validation
Possible situation – II
New product introduced into an existing tablet manufacturing site, with 20 products already being produced Process Cleaning Training
Module 4 Slide 22 of 23 WHO - EDM
Validation
Possible situation – III
A new liquids manufacturing building on an existing site which will produce 2 products. Ventilation Equipment and process Cleaning Training
Module 4 Slide 23 of 23 WHO - EDM
Validation
Possible situation– IV
An existing sterile suite producing 5 products that are terminally sterilized Sterilizers Ventilation and other environmental aspects Equipment and process Cleaning Training