Analytical Method Transfer Program

Richard B. Nguyen.

Associate Scientific Liaison, Chemical Medicines, USP

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

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?

“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>)

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

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

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?

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

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

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

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

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

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

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

Specificity (?)

Linearity

Accuracy

Precision

Quantitation Limit

Detection Limit

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AMT / Validation Characteristics

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

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

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

Compendial methodology to be verified

Acceptance criteria

Suitability reagents

Equipment component

Instrument conditions

Sample preparation

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Verification Protocol for Compendial method

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

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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