Analytical method transfer (module 01)

Analytical Method Transfer

1. Dr. Ravi Kinhikar Analytical Method Transfer GMP –Training Module 01

2. Why Method transfer? Method transfer is the documented process that qualifies a Receiving laboratory (RU) to use an analytical test procedure that originated in the Transferring laboratory (TU), thus ensuring that receiving laboratory has the procedural knowledge and ability to perform transferred analytical test procedure as intended . Dr Ravi Kinhikar, GMP Training Series 2015-16

3. Types of Method Transfer Comparative Testing Co-validation between Two or more Laboratories Revalidation or Partial Validation Analytical Method Transfer Waiver Dr Ravi Kinhikar, GMP Training Series 2015-16

4. Comparative Testing Method Transfer Comparative testing requires predetermined number of samples by both receiving and transferring unit. The results comparison between two Laboratory testing or the results obtained from Joint Analysis at receiving laboratory Method transfer should performed as per pre-approved protocol with predetermined acceptance criteria. Protocol shall inclusive of Number of replicates of test sample, Impurity spiked sample recovery study and precision at LOQ level (as appropriate) Meeting the Predetermine acceptance criteria is necessary to ensure the receiving laboratory is qualified to run the procedure. Dr Ravi Kinhikar, GMP Training Series 2015-16

5. Co-validation between Two or More Lab The Laboratory that performs validation of test procedure is qualifies to run test procedure. Transferring laboratory can involve the receiving laboratory in an inter laboratory co-validation, as a part of validation team and thereby establish the data assessment for Reproducibility (Ruggedness). This assessment should be made based on preapproved protocol specifying the acceptance criteria. Dr Ravi Kinhikar, GMP Training Series 2015-16

6. Revalidation of Analytical Method Revalidation or partial validation is another approach for Analytical Method transfer. Those characteristics/Parameters described in USP general chapter 1224/ ICH Q2, which are anticipated to be affected by the transfer should be address. Dr Ravi Kinhikar, GMP Training Series 2015-16

7. Analytical Method Transfer Waiver The Method transfer may be waived off in certain cases, 1. The new product is having similar composition is comparable to that of existing product and is analyze by the procedure with which receiving unit already has experience. Analytical Method being transferred in Pharmacopoeia and is unchanged, Verification should apply in this case. The analytical Method transferred is same as or very similar to a procedure already in use. The personnel in-charge of Development/Validation/Routine analysis activities of the product at transferring unit are moved to receiving unit. Any eligibility for Method transfer , receiving unit should document it with appropriate justifications. Dr Ravi Kinhikar, GMP Training Series 2015-16

8. Responsibilities of Transferring Unit Provide method-specific training for analysts and other quality control staff , if required; Assist in analysis of QC testing results; Define all methods to be transferred for testing a given product, starting material or cleaning sample; Define experimental design, sampling methods and acceptance criteria; Provide any validation reports for methods under transfer and demonstrate their robustness ; Provide details of the equipment used, as necessary (part of validation report , if available) and any standard reference samples; Provide approved procedures used in testing and review and approve transfer reports. Dr Ravi Kinhikar, GMP Training Series 2015-16

9. Responsibilities of Receiving Unit Review analytical methods provided by the SU, and formally agree on, acceptance criteria before execution of the transfer protocol; Ensure that the necessary like to like equipment for QC is available and qualified at the RU site and are meeting to the requirement of the specified in the test procedure; Ensure that adequately trained and experienced personnel are in place for analytical testing ; Provide a documentation system capable of recording receipt and testing of samples , reporting, recording and collating data. E xecute the transfer protocol; Perform the appropriate level of validation to support the implementation of the methods; and G enerate and obtain approval of transfer reports. Dr Ravi Kinhikar, GMP Training Series 2015-16

10. Possible Experiment design with acceptance criteria Test Replication of Test Set up Acceptance criteria Assay (Stability Indicating) 2 Analyst X 3 test sample in triplicate Different set on Instrument/column/ Independent Solution preparation Comparison of mean variability. Difference should be < 2.0% Impurities/ Degradation/ Residual solvents 2 Analyst X 3 test sample in triplicate Different set on Instrument/column/ Independent Solution preparation. Spiked sample Comparison of Result variability. Difference should be < 25.0% % RSD of replicates standard < 5.0% Cleaning sample 2 Analyst X 3 test sample in triplicate Use spiked samples at three different level of specified concentration All sample spiked above specified limit fail and below specified limit should pass. Dr Ravi Kinhikar, GMP Traing Series 2015-16

11. Content of Method Transfer Protocol Objective Scope Responsibilities Pre-requisites 4.1 Method validation Reference 4.2 Column/Standards/Reagent 4.3 Sample Information (3 batches) 5. Methodology 6. Acceptance criteria 7. Deviations 8. Conclusion : (Method transfer acceptable and successful) Annexure Test sample CoA Reference standard CoA Column Performance certificate Information about equivalent column Dr Ravi Kinhikar, GMP Traing Series 2015-16

12. References ICH guideline Q7 and Q2 WHO Technical Report Series, No. 961, 2011 USP 37 General chapter 〈1224 〉 Transfer of Analytical Procedures. USP 37 General chapter 〈 1225〉 Validation of compendial Procedures. Dr Ravi Kinhikar, GMP Traing Series 2015-16

13. Thanks !!! Dr Ravi Kinhikar, GMP Traing Series 2015-16