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ICH and WHO guidelines defines DQ, IQ, OQ and PQ of equipments

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ICH AND WHO GUIDELINES FOR
VALIDATION OF EQUIPMENTS
Presented By
Mahesh Jagtap
M.Pharm 1st Semester
Guided By
Dr. A. B. Gangurde
Head of Department
Department of Pharmaceutics
K.B.H.S.S trust’s Institute of Pharmacy,
Malegaon.
1
ICH &WHO
GUIDELINES
2
CONTENT
 INTRODUCTION
 ICH GUIDELINES FOR VALIDATION OF EQUIPMENT’S
 WHO GUIDELINES FOR VALIDATION OF EQUIPMENT’S
I. Design qualification (DQ) .
II. Installation qualification (IQ).
III.Operational qualification (OQ).
IV.Performance qualification (PQ).
3
ICH GUIDELINES
 ICH is the "International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use".
 Validation means of ensuring and providing documentary evidence
that processes within their specified design parameters are capable
of repeatedly and reliably producing a finished product of the
required quality.
 ICH is a joint initiative involving both regulators and research-based
industry representatives of the EU, Japan and the US in scientific
and technical discussions of the testing procedures required to assess
and ensure the safety, quality and efficacy of medicines.
4
ICH GUIDELINES FOR VALIDATION OF
EQUIPMENTS
1 meter distance from walls and other obstacles. Easy to operate,
clean and maintainable.
 Working should be at proper commissioned position.
 Certification of equipment.
 Checking of overhead heights.
 Proper source of light.
 Drop down utility system.
5
 Design of equipment.
 Layout of equipment.
 Marking of pipelines as per their flow of direction.
 Sop the equipment.
 Tracing of equipment.
 Identification marking for equipment.
 Cleaning of equipment.
 Distinguishing of the equipment.
 Record of each processing.
6

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ICH AND WHO GUIDELINES FOR VALIDATION OF EQUIPMENTS.pptx

  • 1. ICH AND WHO GUIDELINES FOR VALIDATION OF EQUIPMENTS Presented By Mahesh Jagtap M.Pharm 1st Semester Guided By Dr. A. B. Gangurde Head of Department Department of Pharmaceutics K.B.H.S.S trust’s Institute of Pharmacy, Malegaon. 1
  • 3. CONTENT  INTRODUCTION  ICH GUIDELINES FOR VALIDATION OF EQUIPMENT’S  WHO GUIDELINES FOR VALIDATION OF EQUIPMENT’S I. Design qualification (DQ) . II. Installation qualification (IQ). III.Operational qualification (OQ). IV.Performance qualification (PQ). 3
  • 4. ICH GUIDELINES  ICH is the "International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use".  Validation means of ensuring and providing documentary evidence that processes within their specified design parameters are capable of repeatedly and reliably producing a finished product of the required quality.  ICH is a joint initiative involving both regulators and research-based industry representatives of the EU, Japan and the US in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines. 4
  • 5. ICH GUIDELINES FOR VALIDATION OF EQUIPMENTS 1 meter distance from walls and other obstacles. Easy to operate, clean and maintainable.  Working should be at proper commissioned position.  Certification of equipment.  Checking of overhead heights.  Proper source of light.  Drop down utility system. 5
  • 6.  Design of equipment.  Layout of equipment.  Marking of pipelines as per their flow of direction.  Sop the equipment.  Tracing of equipment.  Identification marking for equipment.  Cleaning of equipment.  Distinguishing of the equipment.  Record of each processing. 6
  • 7. WHO GUIDELINES The documented act of proving that any procedure , process, equipment, material ,activity or system actually leads to expected result  The principles in this guideline may also be applied to the qualification of instruments and testing devices, where appropriate.  Systems, utilities and equipment that may have an impact on the quality of products, should be appropriately qualified. These may include, where appropriate: computerized systems;  water purification systems; heating, ventilation and air conditioning systems; compressed air systems;  Documented impact assessments should support decisions for the exclusion of systems, utilities and equipment from qualification 7
  • 8. WHO Guideline Equipment validation/qualification (EQ) include:  Design qualification (DQ)  Installation qualification (IQ)  Operational qualification (OQ)  Performance qualification (PQ) 8
  • 9. 9
  • 10. DESIGN QUALIFICATION "Design qualification (DQ) defines the functional and operational specifications of the instrument and details for the conscious decisions in the selection of the supplier". 10
  • 11. 11 It include: • Description of the analysis problem Description of the intended use of the equipment • Description of the intended environment Preliminary selection of the functional and performance specifications (technical, environment,safety). • Preliminary selection of the supplier. • Final selection of the supplier and equipment • Development and documentation of final functional and operational specification.
  • 12. "Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument." 12 INSTALLATION QUALIFICATION
  • 13.  Installation Qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.  Before installation:-Obtain manufacturer's recommendations for installation site requirements.  Check the site for the fulfillment of the manufacturer's recommendations (utilities such as electricity, water and gases plus environmental conditions such as humidity, temperature, vibration level and dust).  Allow sufficient shelf space for the equipment itself, related SOPs, operating manuals, logbooks and software. 13
  • 14. 14
  • 15. 15
  • 16. 16
  • 17. 17
  • 18. 18
  • 19. OPERATIONAL QUALIFICATION "Operational qualification (OQ) is the process of demonstrating that an instrument will function according to its operational specification in the selected environment." 19
  • 20. It include: 1.Application S.O.P’s 2.Utilization List 3.Process Description 4. Test Instrument Utilized To Conduct Test 5. Test Instrument Calibration 6.Critical Parameters 7.Test Function (List) 8. Test Function Summaries 20
  • 21.  Operational qualification (OQ) is the process of testing to ensurethat the individual and combined systems function to meet agreed performance criteria and to check how the result oftesting is recorded.  The purpose is to ensure that all the dynamic attributes comply with the original design. Each of the instrument's function are checked to ensure that they conform to the manufacturer's specifications. This includes the use of certified, traceable electrical simulators and standards to verify that the equipment is processing input signals correctly. 21
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  • 32. PERFORMANCE QUALIFICATION "Performance Qualification (PQ) is the process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use “IM 32
  • 33. Performance qualification (PQ), also called process qualification,is the process of testing to ensure that the individual and combined systems function to meet agreed performance criteria on a consistent basis and to check how the result of testing is recorded. The purpose is to ensure that the criteria specified can be achieved on a reliable basis over a period of time. The performance of the equipment for its routine analytical use is checked to ensure that this complies with its specification.The temperature sensor readings are compared with a certified reference thermometer. After ca bration, the conductivity sensor readings are compared using certified, traceable control standards. 33
  • 34. Control Standards of similar values to the intended test samples must be used for PQ.Performance Qualification (PQ) is the process of demonstrating that an instrument consistently performs according to a specification appropriate to its routine use. Important here is the word consistently. The test frequency is much higher than for OQ. Another difference is that PQ should always be performed under conditions that are similar to routine sample analysis. 34
  • 35. 35 PQ should be performed on a daily (or at least a weekly) basis, or whenever the instrument is used. The test frequency depends not only on the stability of the equipment but also on everything in the system that may contribute to the analysis results. 1. Define the performance criteria and test procedures. 2. Select critical parameters. 3. Define the test intervals.
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  • 44. REFRENCES 1. https://www.scribd.com/document/353461168/Guidelines-Validation- Qualification-Systems-utilities-equipment-QAS16-673 2. https://www.slideshare.net/dhavalrock24/concept-of-ursdqiqoqpq?from_search=1 3. Potdar MA, "cGMP, current good manufacturing practises for pharmaceuticals", 2nd reprint, Pharmamed press, Hyderabad, p. 85,88-101,413-423. 4. Joseph Busfield. cGMP, instrument and calibration. "Facilities, utilities and requirements, GXP, Ivt network". Feb 21,2007;5-7. Available from: http://www.ivtnetwok.com/article/cgmp-equipment-instruments-and- calibration 5. Guidelines: ICH. "ICH harmonization for better health". Available from: http://www.ich.org/products/guidelines.html. 6. Essential medicines and health products information portal. "WHO expert committee on specifications for pharmaceutical preparations". World Health Organization. Technical report series no. 902-36th report.2002. Anex3.part2:12 44