Basic Principles of GMP Qualification and Validation Section
Basic Principles of GMP Qualification and Validation Section 4 Module 4 | January 2006 Slide 1 of 28 STOP
Qualification and Validation Objectives l To review basic aspects of qualification and validation l To understand the scope of qualification and validation l Introduction to documentation associated with validation (See also Supplementary Training Module on Validation) Module 4 | January 2006 Slide 2 of 28 STOP
Qualification and Validation Definitions Validation l 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 l 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 Module 4 | January 2006 Slide 3 of 28 STOP
Qualification and Validation Principle l Essential part of GMP l Manufacturer to identify what qualification and validation work is required l Prove that critical aspects of work are controlled l Key elements of qualification and validation defined and documented 4. 1, 4. 2, 4. 8 Module 4 | January 2006 Slide 4 of 28 STOP
Qualification and Validation Scope l Documented evidence to prove that, e. g. ä Premises ä Supporting utilities ä Equipment have been designed in accordance with GMP l Also referred to as Design Qualification (DQ) where appropriate 4. 3(a) Module 4 | January 2006 Slide 5 of 28 STOP
Qualification and Validation Scope l Documented evidence to prove that, e. g. ä Premises ä Supporting utilities ä Equipment have been built and installed in accordance with their design specifications l Also referred to as Installation Qualification (IQ) 4. 3(b) Module 4 | January 2006 Slide 6 of 28 STOP
Qualification and Validation Scope l Documented evidence to prove that, e. g. ä Supporting utilities ä Equipment operate in accordance with their design specifications l Also referred to as Operational Qualification (OQ) 4. 3(c) Module 4 | January 2006 Slide 7 of 28 STOP
Qualification and Validation Scope l Documented evidence to prove that, e. g. ä Supporting utilities ä Equipment perform consistently in accordance with their design specifications – see also next slide on PV l Also referred to as Performance Qualification (OQ) 4. 3(d) Module 4 | January 2006 Slide 8 of 28 STOP
Qualification and Validation Scope l Documented evidence to prove that: ä A specific process will consistently produce a product meeting its predetermined specifications and quality attributes l Also referred to as Process Validation (PV) 4. 3(d) Module 4 | January 2006 Slide 9 of 28 STOP
Qualification and Validation Scope Qualification and validation: l Applicable to any aspect of operation which may affect the quality of the product ä Directly or indirectly l Includes premises, facilities (utilities), equipment, processes l Includes significant changes 4. 4 Module 4 | January 2006 Slide 10 of 28 STOP
Qualification and Validation Principle l Qualification and validation should be done in accordance with an ongoing programme ä Initial qualification and validation ä Annual review l Maintain continued validation status l Policy described in relevant documentation, e. g. quality manual, or Validation Master Plan 4. 5, 4. 6 Module 4 | January 2006 Slide 11 of 28 STOP
Qualification and Validation Types of Documentation l Validation Master Plan (VMP) l Validation protocols l Validation reports l Standard Operating Procedures (SOPs) Module 4 | January 2006 Slide 12 of 28 STOP
Qualification and Validation Documentation l Clearly defines responsibility of performing validation l Conducted in accordance with predefined, approved validation protocols l Recorded results and conclusions presented in written validation reports – prepared and stored l Processes and procedures should be established on the basis of these results 4. 7 – 4. 10 Module 4 | January 2006 Slide 13 of 28 STOP
Qualification and Validation Importance: l Premises, utilities, equipment and processes l Critical importance and particular attention paid to validation of: ä Analytical test methods ä Automated systems ä Cleaning procedures 4. 11 Module 4 | January 2006 Slide 14 of 28 STOP
Basic Principles of GMP l What are the qualification and validation requirements here for this piece of equipment, as well as the step in production? Module 4 | January 2006 Slide 15 of 28 STOP
Qualification and Validation WHO References l Good manufacturing practices (GMP): guidelines on the validation of manufacturing processes l Validation of analytical procedures used in the examination of pharmaceutical materials Annex 6 Module 4 | January 2006 Slide 16 of 28 STOP
Qualification and Validation Example of priorities for process validation Type of process l New l Existing: Requirement Every new process before approval for routine ä Sterile products All processes affecting the sterility, and manufacturing environment including sterilization stage ä 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 | January 2006 Slide 17 of 28 STOP
Qualification and Validation l The Validation Master Plan may contain elements (and policy) such as: ä Approval page and table of contents ä Introduction and objectives ä Facility and process description ä Personnel, planning and scheduling ä Responsibilities of validation team members ä Process control aspects ä Equipment, apparatus, processes and systems qualified, validated – and to be qualified or validated ä Acceptance criteria ä Documentation, e. g. validation protocols and reports ä SOPs ä Training requirements and other elements… Module 4 | January 2006 Slide 18 of 28 STOP
Qualification and Validation l A qualification or validation protocol may contain: ä ä ä ä 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) Module 4 | January 2006 Slide 19 of 28 STOP
Qualification and Validation l A qualification or validation report should reflect the elements of the protocol, and may contain elements such as: ä Title ä Objective of the study ä Reference to the protocol ä Details of materials, equipment, instruments, personnel ä Programmes and cycles used ä Details of procedure and test methods … etc. Module 4 | January 2006 Slide 20 of 28 STOP
Qualification and Validation Group Session 1: Option 1 l From your experience of factory inspections, what progress has been made in introducing validation in your country? l What are the major obstacles and how can they be overcome? Module 4 | January 2006 Slide 21 of 28 STOP
Qualification and Validation Group Session 1: Option 2 l List some documents related to validation, that you expect to find at a manufacturing site l Identify aspects in each document that you would evaluate or assess l What problems do you anticipate the company faced when it prepared these documents? Module 4 | January 2006 Slide 22 of 28 STOP
Qualification and Validation Possible Issues l Lack of time l Lack of personnel l Lack of experience and knowledge l Changes to the process l Prospective versus retrospective validation l Lack of documentation infrastructure l Lack of implementation of validation l Poorly designed documents Module 4 | January 2006 Slide 23 of 28 STOP
Qualification and Validation Group Session 2 l List the aspects that you will evaluate when assessing the validation for the project that your group has been given l Identify the critical parameters that should have been evaluated by the manufacturer l List the tests to be carried out and comment on the acceptance criteria to be set Module 4 | January 2006 Slide 24 of 28 STOP
Qualification and Validation Possible situation – I l Refurbishment of a liquids department, producing a single product on an established site with an existing purified water system l Ventilation system ä Equipment and process ä Training Module 4 | January 2006 Slide 25 of 28 STOP
Qualification and Validation Possible situation – II l New product introduced into an existing tablet manufacturing site, with 20 products already being produced ä Process Cleaning ä Training Module 4 | January 2006 Slide 26 of 28 STOP
Qualification and Validation Possible situation – III l A new liquids manufacturing building on an existing site which will produce 2 products ä Ventilation ä Equipment and process ä Cleaning ä Training Module 4 | January 2006 Slide 27 of 28 STOP
Qualification and Validation Possible situation – IV l An existing sterile suite producing 5 products that are terminally sterilized ä ä ä Module 4 | January 2006 Sterilizers Ventilation and other environmental aspects Equipment and process Cleaning Training Slide 28 of 28 STOP
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