Elaboration of New USP General Chapter <1220> - Analytical Procedure Lifecycle - announced

Recommendation

9/10 May 2023

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From QbD to Process Validation

On June 24, 2016, the USP announced the elaboration of a new general chapter <1220> "The Analytical Procedure Lifecycle". Input Deadline is July 29, 2016.

The suggested audience are drug product manufacturers, dietary supplement manufacturers, testing organizations, and drug product related regulatory agencies.

"An analytical procedure must be shown to be fit for its intended purpose. It is useful to consider the entire lifecycle of an analytical procedure when approaching development of the procedure, i.e. its design, development, qualification, and continued verification. The current concepts of validation, verification, and transfer of procedures address portions of the lifecycle but do not consider them holistically. This General Chapter intends to more fully address the entire procedure lifecycle and define concepts which may be useful." 

The approach is consistent with the concepts of Quality by Design (QbD) as described in ICH Guidelines Q8 (R2), 9, 10, and 11 and with the expected new ICH Guideline Q12 (Lifecycle Management).

Preliminary outline:
THE LIFECYCLE APPROACH 

• focal point: Analytical target profile (ATP), comparable to the Quality Target Product Profile (QTPP).

STAGE 1: PROCEDURE DESIGN, DEVELOPMENT, AND UNDERSTANDING

• Procedure design and development,
• Procedure understanding,
• Preparing for qualification.

STAGE 2: PROCEDURE PERFORMANCE QUALIFICATION

STAGE 3: IMPLEMENTATION AND CONTINUED PROCEDURE PERFORMANCE VERIFICATION

• Routine monitoring,
• Analytical control strategy,
• Knowledge management,
• Change control.

Anticipated proposed design phase activities:

Two Stimuli articles are scheduled for PF 42(5) [Sep.–Oct. 2016]:

• Analytical Target Profile: Structure and Application throughout the Analytical Lifecycle,
• Analytical Control Strategy.

Two stimuli articles have already been published:

• Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. PF 39(5) [Sep.–Oct. 2013],
• Fitness for Use: Decision Rules and Target Measurement Uncertainty. PF 42(2) [Mar.–Apr. 2016].

Additionally, the USP proposed a revision of general chapter <1225> "Validation of compendial procedures" in PF 42(2) [March-April 2016].
This chapter is being revised to incorporate a section on "Lifecycle Management of Analytical Procedures". The revision is an attempt to better align the validation concept with the recently (July 2015) issued FDA guidance "Analytical Procedures and Methods Validation for Drugs and Biologics", which also includes a section on "Life Cycle Management of Analytical Procedures".

Estimated proposal for the new general chapter <1220> "The Analytical Procedure Lifecycle" is PF 43(1) [Jan.–Feb. 2017].

Furthermore, an USP and ECA Joint Conference and Workshop on Lifecycle Approach of Analytical Procedures will be held November 8-9, 2016 in Prague, Czech Republic.

For more information please visit the USP website - Notices- General Chapter Prospectus - The Analytical Procedure Lifecycle.