27-29 February 2024
The MHRA opened a three-month public consultation (until August 31, 2019) on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeia.
According to ICH Q8, Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (QRM). The application of QbD principles to analytical methods is currently being highly dscussed by industry, regulators and scientists.
Compendia (like, for example, Ph. Eur. and USP) are a key component of a regulatory framework. For medicinal products in the UK pharmacopoeial standards are published in the British Pharmacopoeia (BP). Since pharmacopoeial standards develop with advances in manufacturing science and technology, the MHRA has explored how AQbD principles may be applied to pharmacopoeial standards in collaboration with industry experts. Therefore, the 15 page consultation paper includes a series of examples to illustrate the potential models for inclusion in the pharmacopoeia.
In particular the document contains:
The Agency conducted a case study that focused on how AQbD principles could be applied to the development of a pharmacopoeial assay procedure for atorvastatin tablets. The case study was led by representatives from the Pharmacopoeia, Licensing Division and GMDP Inspectorate in collaboration with industry experts. It sought to learn about AQbD concepts through a laboratory-based investigation of:
Example 5 shows how an ATP only approach could look like:
ATP: The analytical method is capable of quantifying the active substance in the tablets
In addition, assay procedures should be demonstrated to conform with these requirements.
The consultation follows the exploration of AQbD in ICH´s recently released concept paper ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation from November 2018.
The consultation asks manufacturers to rank their preferences among the five examples for presenting assay procedures within the BP. With the consultation MHRA hopes to learn more about the opportunities and challenges relating to pharmaceutical quality and how AQbD concepts are used by manufacturers of medicinal products.
Read more about MHRA´s Consultation on the application of Analytical Quality by Design (AQbD) principles to pharmacopoeial standards for medicines.