New USP chapter details lifecycle approach to analytical testing
The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers to switch analytical methods for testing medicines.
Industry officials complained at a recent meeting that the high cost involved in securing regulatory approval for changes serves as a disincentive for making needed changes. (RELATED: Upcoming ICH guidelines should ease post-approval changes for analytical methods, Regulatory Focus, 14 July 2021).
According to a USP stimuli article published in 2016 that established the framework for the chapter, “the current concepts of validation, verification, and transfer of procedures address portions of the lifecycle but do not consider it holistically.” The intent of the chapter “is to more fully address the entire procedure lifecycle and define concepts that may be useful. This approach is consistent with the concept of quality by design (QbD) as described in International Council for Harmonisation (ICH) Q8-R2, Q9, Q10, and Q11.”
The chapter said that the analytical target profile (ATP) is a “fundamental” component of the lifecycle approach. It defines the ATP as a “prospective description of the desired performance of an analytical procedure that is used to measure a quality attribute, and it defines the required quality of the reportable value produced by the procedure, aligned with the quality target product profile (QTPP). The ATP is based on the intended use for the procedure and, for quantitative or semi-quantitative procedures, should include upper limits on the precision and accuracy (bias) of the reportable value.”
The ATP consists of three parts: Stage 1 for procedure design, Stage 2 for procedure performance qualification and Stage 3 for ongoing performance verification.
- Stage 1 covers the knowledge gathering, risk evaluation and control, and understanding “the effect of procedure parameters (e.g., temperature, wavelength, flow rate, etc.) on procedure performance .”
- Stage 2 certifies that the performance characteristics meet established criteria, and this is where the analytical control strategy is finalized.
- Stage 3 is the monitoring phase where the method’s performance is assessed to ensure that it continues to meet the criteria set in the ATP. This is the period when the procedure may be modified, possibly returning to Stage 1 or 2.
How to change analytical methods
The chapter addresses how to assess the impact of changes in analytical procedures. These changes may be prompted by routine monitoring, adopting to a new technology, or making changes in the ATP.
The chapter states that “the level of activities required to confirm that a changed analytical procedure is producing fit-for-purpose data will depend on an assessment of the risk associated with the change, the knowledge available about the procedure, and the effectiveness of the [analytical control strategy] ACS.”
The USP chapter also complements other regional efforts to ease the post-approval change process for analytical methods. In 2019, the UK’s Medicines and Health care products Regulatory Agency (MHRA) launched a consultation on its plans to apply analytical by design (AQbD) principles to its pharmacopeial standards. (RELATED: MHRA Consults on Analytical Quality by Design Principles, Regulatory Focus, 4 June 2019).
USP chapter 1220
