Analytical Method Transfer Program. Richard B. Nguyen. Associate Scientific Liaison, Chemical Medicines, USP
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1 Analytical Method Transfer Program Richard B. Nguyen. Associate Scientific Liaison, Chemical Medicines, USP
2 Outline Requirements for an AMT Program Develop Your AMT Program Qualify Your AMT Program On-going Monitoring and Post Transfer Support Interactive Discussion 2
3 What is Analytical Method Transfer? Protocol driven study with pre-determined acceptance criteria Demonstration of a laboratory s competency in conducting a particular procedure Verification of a method s suitability for its intended use 3
4 USP Definition (from chapter <1224>) The transfer of analytical procedures (TAP), is the documented process that qualifies a laboratory (the receiving unit) to use an analytical test procedure that originated in another laboratory (the transferring unit), thus ensuring that the receiving unit has the procedural knowledge and ability to perform the transferred analytical procedure as intended. 4
5 Another Definition for AMT A process to ensure that a receiving unit implements an analytical procedure in compliance with approved protocols and achieve the same technical level as the sending unit. 5
6 Method Transfer vs. Validation Method transfer and validation are closely related A.M.T involves multiple laboratories and companies Different instruments and facilities Different approaches to validation Different expectations Adapt validated method to new facility/instrument Meet new facility validation requirements Preserve validated state of method 6
7 Why Need Method Transfer? Good business practice R&D to QC QC to Contract labs Outsourcing Contract Manufacturing Compliance From old to newer instruments 7
8 Types of Analytical Method Transfer Comparative Testing Requires analysis of pre-determined no. samples (same lot) by the SU & RU Protocol, acceptance criteria are approved by SU and RU Co-validation RU has been identified to be a part of the intermediate precision evaluation of the method validation. Re-validation Easier to revalidate the method in the RU rather than to transfer it RU will implement procedure different from the one used by the SU Transfer waiver (self qualification) 8
9 A.M.T Steps Plan Initiated - Discussions Review of Method and Validation Laboratory Evaluation Transfer Protocol Written Transfer Protocol Approved Experimental data from a transfer study generated Transfer Report Written Transfer Report Approved Transfer Complete (?). 9
10 AMT Process Overview Stage Pre-Transfer Transfer Post Transfer Activity Appointment of the leader from the SU or overall leader Appointment of the Analytical Transfer Team (ATT) Provision of appropriate documentation from SU to RU Pre-transfer meetings (SU & RU) ATT meetings: - Launch of the transfer - Decide transfer strategy - Decide samples to be used for inter-lab study - Training on analytical procedures. Analytical Transfer Protocol Execution of protocol Data, and evaluation of results Analytical Transfer Report and conclusion Establish final version of the method Support to the QC of the RU in case issues arise If applicable, assure supply of critical materials from SU to RU for a defined period 10
11 The successful of method transfer relies on communication between the sending and the receiving units. 11
12 Pre-transfer Communications Understand the details about the Method and Product before the transfer Method Test Category Intended Use Acceptance Criteria for results Product Formulation Strength Understand the goal of transfer 12
13 AMT Protocol Must be written by the Analytical Transfer Team Approved by the site quality management of both the sending and receiving units Must include a detailed description of the activities to be conducted, and the acceptance criteria for measure of a successful transfer 13
14 Objective / Scope / Responsibilities Instruments / Apparatus Test Materials / Reagents Experimental design (e.g. no. of determinations, operators, samples, format of data reporting) Procedures: Sample / Standard Preparations Sys Suit / Calculations / Results / Accept. Crit References AMT Protocol Signature and approval page 14
15 SU Responsibilities Pre-transfer: Compile all relevant info. on the analytical procedures Provide documents / technical supports / training / expertise to RU Provide test materials Execution of Transfer: Conduct comparative testing / co-validation No different than RU Tabulate results / transfer report / complete transfer report Post transfer: Continue to provide support to RU as needed 15
16 RU Responsibilities Pre-transfer: Receive all relevant info. / test materials / procedures Obtain necessary trainings, knowledge from SU Conduct familiarized-procedure experiment Execution of Transfer: Conduct comparative testing / co-validation / re-validation or self qualification Evaluate results vs. acceptance criteria Handle deviation and outlier results Complete transfer report Post transfer: Expect to be competent in conducting the procedures 16
17 AMT / Validation Characteristics Specificity (?) Linearity Accuracy Precision Quantitation Limit Detection Limit 17
18 Receiving Unit Re-validation / Self Qualification Measure by: Successfully of revalidating the analytical procedure Successfully passing the system suitability requirements of a compendial monograph Comparative testing against a certified reference sample or using a certificate of analysis 18
19 Successful Analytical Method Transfer Maintain the Validated State of the method and meet all regulatory requirements Good Communication is key of success Pre-determined expectations Clearly documented and communicated technical details Pre-transfer evaluation by experienced technical staff at receiving unit Technical contact available for troubleshooting / knowledge sharing at sending unit 19
20 Q & A 20
21 Interactive Session 21
22 Thank you! Happy Holidays!!!
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25 USP Monographs written document, or standard, that describes an item (e.g., a drug substance, a drug product, or food chemical). A monograph published in USP compendium provides: the name of a substance; its definition; package, storage, and labeling requirements; and information on tests needed to ensure the substance is of the appropriate strength, quality, and purity. Monographs give scientists, governments, manufacturers, and others a public standard by which to evaluate an article s quality. The existence of a public standard for substances consumed in the global marketplace is a key element of the safety nets that help maintain and improve public health. 25
26 Verification Protocol for Compendial method Compendial methodology to be verified Acceptance criteria Suitability reagents Equipment component Instrument conditions Sample preparation 26
27 USP METHOD TRANSFER USP Monographs USP Chapter <621> USP Chapters <1224>, <1225>, <1226> <1224>Transfer of Analytical Procedures <1225> Elements Recommended for the Transfer of Analytical Procedures <1226> Verification of Compendial Procedures 27
28 USP Monographs: Standards USP: Creates the official public monographs for prescription and over-the counter medications in the United States in conjunction with the pharmaceutical industry and others. Monographs are published in the United States Pharmacopeia and National Formulary (USP NF). The current USP NF comprises more than 4,500 monographs and are named in the U.S. Federal Food, Drug, and Cosmetic Act as the official compendia of the nation. USP NF standards are also used in more than 130 countries 28
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