Analytical Method Transfer Program 1_LAB_Nyu… · · 2016-12-12Analytical Method Transfer...
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Analytical Method Transfer Program
Richard B. Nguyen.
Associate Scientific Liaison, Chemical Medicines, USP
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Requirements for an AMT Program
Develop Your AMT Program
Qualify Your AMT Program
On-going Monitoring and Post Transfer Support
Interactive Discussion
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Outline
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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
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What is Analytical Method Transfer?
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“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.”
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USP Definition (from chapter <1224>)
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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.
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Another Definition for AMT
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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
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Method Transfer vs. Validation
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Good business practice
◦ R&D to QC
◦ QC to Contract labs
Outsourcing
◦ Contract Manufacturing
Compliance
◦ From old to newer instruments
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Why Need Method Transfer?
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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)
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Types of Analytical Method Transfer
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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 (?).
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A.M.T Steps
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AMT Process Overview
Stage Activity
Pre-Transfer • 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.
Transfer •Analytical Transfer Protocol
•Execution of protocol Data, and evaluation of results
•Analytical Transfer Report and conclusion
Post Transfer •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
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The successful of method transfer relies on
communication between the sending and the
receiving units.
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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
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Pre-transfer Communications
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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
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AMT Protocol
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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
Signature and approval page
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AMT Protocol
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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
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SU Responsibilities
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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
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RU Responsibilities
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Specificity (?)
Linearity
Accuracy
Precision
Quantitation Limit
Detection Limit
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AMT / Validation Characteristics
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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
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Receiving Unit
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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
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Successful Analytical Method Transfer
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Q & A
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Interactive
Session
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Thank you! Happy Holidays!!!
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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.
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USP Monographs
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Compendial methodology to be verified
Acceptance criteria
Suitability reagents
Equipment component
Instrument conditions
Sample preparation
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Verification Protocol for Compendial method
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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
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USP METHOD TRANSFER
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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
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USP Monographs: Standards
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