validation part6
DESCRIPTION
WHO: Supplementary Training Modules on Good Manufacturing PracticeTRANSCRIPT
Validation | Slide 1 of 27 August 2006
Validation
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 937, 2006. Annex 4.
Validation | Slide 2 of 27 August 2006
ValidationValidation
Part 1. General overview on qualification and validation
Part 2. Qualification of HVAC and water systems
Part 3. Cleaning validation
Part 4. Analytical method validation
Part 5. Computerized system validation
Part 6. Qualification of systems and equipment
Part 7. Non sterile product process validation
Validation | Slide 3 of 27 August 2006
Qualification of systems and equipment
Part 6
Supplementary Training Modules on Good Manufacturing Practice
WHO Technical Report Series, No. 937, 2006. Annex 4. Appendix 6.
Validation | Slide 4 of 27 August 2006
ValidationValidation
Objectives
To discuss the principles of qualification of systems and equipment, with specific focus on:
The different stages of qualification
Requalification and
Qualification of “in use” systems and equipment
Validation | Slide 5 of 27 August 2006
ValidationValidation
Principle
Systems and equipment: Appropriately designed, located, installed, operated and maintained
Critical systems and equipment – should be qualified
May include, where appropriate:– Water purification systems, air-handling systems,
autoclaves, coating machines
Continued suitable performance needed – Why? To ensure batch-to-batch consistency
1.1 – 1.3
Validation | Slide 6 of 27 August 2006
ValidationValidation
Scope
Guidelines describe the general aspects of qualification for systems and equipment
Normally qualification would be applicable to critical systems and equipment whose performance may have an impact on the quality of the product
2.1 – 2.2
Validation | Slide 7 of 27 August 2006
ValidationValidation
General
Qualification policy for systems and equipment
To include instruments used in production and quality control
New systems and equipment: All stages of qualification applicable (DQ, IQ, OQ and PQ)
In some cases: Not all stages of qualification may be required– e.g. electrical supply systems
3.1 – 3.4
Validation | Slide 8 of 27 August 2006
ValidationValidation
General (continued)
Systems: Qualified before equipment
Equipment: Qualified before routine use
Systems and equipment: Periodic requalification, as well as requalification after change
Certain stages done by the supplier or a third party
Maintain the relevant documentation, e.g.– standard operating procedures (SOPs), specifications and
acceptance criteria, certificates and manuals 3.5 – 3.9
Validation | Slide 9 of 27 August 2006
ValidationValidation
General (continued)
Qualification should be done in accordance with predetermined and approved qualification protocols
The results of the qualification should be recorded and reflected in qualification reports
The extent of the qualification should be based on the criticality of a system or equipment, e.g.
– Blenders, autoclaves or computerized systems
3.10 – 3.11
Validation | Slide 10 of 27 August 2006
ValidationValidation
Blender
Discuss the approach of qualification of a newly installed blender
Validation | Slide 11 of 27 August 2006
ValidationValidation
Stages of qualification
3.11
Design qualification
Installation qualification
Operational qualification
Performance qualification
Validation | Slide 12 of 27 August 2006
ValidationValidation
Stages of qualification
3.11.
Design qualification
Installation qualification
Operational qualification
Performance qualification Change control
Validation | Slide 13 of 27 August 2006
ValidationValidation
Design qualification
User requirements should be considered when deciding on the specific design of a system or equipment
A suitable supplier should be selected for the appropriate system or equipment (approved vendor)
4.1 – 4.2
Validation | Slide 14 of 27 August 2006
ValidationValidation
Installation qualification
Correct installation as per plan and protocol
Normally advised to prepare requirements for calibration, maintenance and cleaning at this stage
Identification and verification of all system elements, parts, services, controls, gauges and other components
Calibrate the measuring, control and indicating devices– against appropriate, traceable national or international
standards5.1 – 5.4
Validation | Slide 15 of 27 August 2006
ValidationValidation
Installation qualification (2)
Documented records for the installation– installation qualification report
Indicate satisfactory installation
Include details, e.g.– The supplier and manufacturer– System or equipment name, model and serial number– Date of installation– Spare parts, relevant procedures and certificates
5.5
Validation | Slide 16 of 27 August 2006
ValidationValidation
The handout shows a typical format for
"An installation qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or piece of equipment
5.5
Validation | Slide 17 of 27 August 2006
ValidationValidation
Operational qualification
Systems and equipment should operate correctly – operation verified as in the qualification protocol
Studies on critical variable to include conditions encompassing upper and lower operating limits and circumstances (i.e. “worst case conditions”)
To include verification of operation of all system elements, parts, services, controls, gauges and other components
6.1 – 6.3
Validation | Slide 18 of 27 August 2006
ValidationValidation
Operational qualification (2)
Documented records (Operational qualification report)
Finalize and approve SOP (operation)
Training of operators provided – training records
Systems and equipment released for routine use after completion of operational qualification, provided that:
– All calibration, cleaning, maintenance, training and related tests and results were found to be acceptable
6.4 – 6.7
Validation | Slide 19 of 27 August 2006
ValidationValidation
The handout shows a typical format for:
"An operational qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or piece of equipment
6.7
Validation | Slide 20 of 27 August 2006
ValidationValidation
Performance qualification
Systems and equipment should consistently perform in accordance with design specifications – verified in accordance with a performance qualification protocol
Documented records – performance qualification report
Show satisfactory performance over a period of time
Manufacturers to justify the selected period
7.1 – 7.2
Validation | Slide 21 of 27 August 2006
ValidationValidation
The handout shows a typical format for:
"A performance qualification protocol / report"
It reflects the minimum information that should be included
This is an example – and should be used as such
Specific formats need to be designed for a specific system or piece of equipment
7.2
Validation | Slide 22 of 27 August 2006
ValidationValidation
8.1 – 8.3
Requalification
Defined schedule
Periodic
After change
Validation | Slide 23 of 27 August 2006
ValidationValidation
Requalification
Defined schedule
Frequency based onFactors
Results of calibrationmaintenance ,verification
Periodic
After change
Part ofChange control procedure
Extent based onRisk assessment
8.1 – 8.3
Validation | Slide 24 of 27 August 2006
ValidationValidation
What about "old manufacturers" who have not performed DQ, or IQ for existing, in-use systems and/or equipment?
Validation | Slide 25 of 27 August 2006
ValidationValidation
Qualification of “in-use” systems and equipment
Data to support and verify the suitable operation and performance of systems and equipment
Should include operating parameters and limits for critical variables, calibration, maintenance and preventive maintenance, standard operating procedures (SOPs) and records
9.1 – 9.2
Validation | Slide 26 of 27 August 2006
ValidationValidation
Validation | Slide 27 of 27 August 2006
ValidationValidation
Group session