Requalification

In this slide contains introduction, qualification, preventive maintenance, requalification method.
Presented by: Malarvannan M (Department of pharmaceutical analysis).RIPER, anantapur

1. 1 A Seminar as a part of curricular requirement for I year M. Pharm II semester Presented by M.MALARVANNAN. (20L81S0704). M.PHARM Department of Pharmaceutical Analysis REQUALIFICATION

2. 2 S.NO CONTENT 1 Introduction 2 Qualification 3 “V” Model for Qualification and Validation 4 Qualification phrases 4Q Model 5 Requalification method 6 Requalification procedure 7 Preventive maintenance 8 Role of instrument requalification 9 Requalification required for 10 Reason for conducting instrument Requalification 11 Reference Content Table

3. 3 Requalification:- The action of repeating the qualification or reconfirming that process, product or equipment is suitable for a particular position or task. Requalification of systems and equipment should be done in accordance with a defined schedule. The frequency of requalification may be determined on the basis of factors such as the analysis of results relating to calibration, verification and maintenance. Introduction

4. 4 Qualification : ensuring in the case of new equipment/facilities or equipment entering into service that they serve their intended purpose.   Requalification : ensuring that the equipment is still in the qualified state after a change AND periodical assessment of equipment within defined time intervals.   GMP definitions

5. 5 Qualification Qualifying the instrument, Utility, System By means of Test Working conditions Ok/Not Ok Creating a document evidence It shows the stability of instrument for intended purpose

6. 6 “V” Model for Qualification and Validation

7. 7 Qualification phrases 4Q Model

8. 8 DQ should provide documented evidence that the design specification were met and are in accordance with URS. User requirement specifications: Product requirements Process & operation requirements Operation ranges GMP , operation & safety requirements FAT and SAT: It should be performed to verify the suitability of the system at site, prior to the subsequent stages of qualification. Design Qualification

9. 9 DQ- template

10. 10 Demonstrate that equipment's has been installed as per design and installation requirements. Installation checklist: Civil requirements Electrical Production Measuring instruments Utilities and piping Safety issues Operation manual & SOP’s Critical stages Spare parts list etc.. Installation qualification

11. 11 Tests that meet the functionality requirement of process, system and equipment. To include a condition or a set of condition encompassing upper and lower operating limits, and “worst case conditions”. Finalisation of calibration, operation and cleansing procedures. Operator training and preventive maintenance requirements Conclusion to approve/ release the facilities, systems and equipment's. Operational Q ualification

12. 12 PQ should include, but not be limited to the following: Test, using production materials, qualified substitutes or simulated products. Test to include conditions or set of conditions encompassing upper and lower limits. Although PQ is described as a separate activity. It may in some cases be appropriate to perform conjunction with OQ. Performance Qualification

13. 13 TYPE REQIRMENT EXAMPLE GROUP-A Only IQ, Formal OQ Hot plate, stirrers, Oven, Centrifuge,.. GROUP-B IQ, OQ mandatory PH meters, weighing balance, Polarimeter, Conductivity meter... GROUP-C IQ, OQ, PQ must All instrument with system (CPU) /21 CFR Part-II, HPLC, UV, GC, LC-MS, FT-IR.... Types of instrument as per GMP/FDA

14. 14 Qualification of Analytical Instruments SST-----Check----Meet the limit---------- Go For QC sample SST-----Check----Not meet the limit-----Go for instrument Qualification

15. 15 Requalification Method

16. 16 Requalification includes the following terms: *Maintaining Status for Calibration *Preventive maintenance *Change management Requalification Procedure

17. 17 The quality of product directly associated with accuracy of instrument Producing them. If the instrument not calibrated or If damaged They will surely affect the products. It is important to remember instrument and equipment will not always calibrated. At some point the level of calibration Go down and it will affect the final measurement and quality of final product. It must be kept in excellent condition at all time. Maintaining Status for Calibration

18. 18 Manufacturers recommendations Annually Or biannually After a damaging incident As demanded by project Before or after major product Semi-annually, quarterly, Or monthly How it is Done frequently (calibration or Recalibration )

19. 19 It is regularly performed on a piece of equipment Lessen The likelihood Of it failing. It is performed while the Equipment is still working So that it does not Breakdown unexpectedly. Preventive maintenance

20. 20 Original manufacturers Recommendation Meeting the regulatory requirements Maintaining the performance specifications of instrument Increasing the life of equipment Maximizing uptime And minimizing corrective Maintenance Assuring the efficiency of instrument The topical rationale for performing Preventive maintenance

21. 21 Change management is a system approach to Dealing with the Transition or transformation of an organization goals or process. The purpose of this To implement strategies of effective change, controlling change. Change and deviation management is the central part of QMS. According to FDA and ICH a formal CMS should be established to evaluate all changes. Change management

22. 22 Decrease Bias Decrease OOS Decrease OOC Reassure the equipment function, working conditions Reassure the implement process/ procedure is correct Provide high degree of assurance Role Of Instrument Requalification

23. 23 Significant change in batch size Change in operating parameters Component specification have changed Accessories or components added To the previously qualified equipment's. Process change that potentially impact on Product effectiveness or quality. Requalification required for?

24. 24 Identify and correct the deficiencies Observed during Qualification Criteria For Qualification test need to be added Qualification changes to equipment or Process involving equipment CAPA Failure Inspection /Audit/PQR/finding/Recommendations Results of PM, calibration Programs Upgrade of equipment Reason For Conducting Requalification

25. 25 ECA Academy Your GMP/GDP Information source “ Qualification, Requalification - frequent Obscurities”, 2013. Ludwig Huber. “ US & EU GMP Guidelines on analytical instrument Qualification and related warning letters”, Agilent tech slides, 2014. www.Labcompilence.com/Agilent EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, volume-4, Annex 15: Qualification and Validation, 2015 Manoj V. Kumbhar . “ Preventive maintenance and calibration ”, 2016. www.slideshare.com Melissa Stappen , ValSource “Using Preliminary Hazard Analysis To Determine Equipment And Instrument Requalification Frequency” , 2018. R.D. McDowall, Paul Smith. “ Data Integrity and USP : Part 3: Monitoring and Requalification” , LCGC Europe,  LCGC Europe-01-01-2019, Volume 32, Issue 1 Pages: 28–32 Pharma beej , “ Equipment Qualification principles and practice in pharma” , 2021. Reference: