Regulatory Report: Development of an Analytical Procedure

ICH has developed a draft of the new ICH Quality Guideline, ICH Q14, Development of Analytical Procedures, and the revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures, all two approved on March 22, 2022 for public consultation. The draft, along with other ICH guidance on validation and analytical procedures, can be viewed here.

The Analytical Procedure Validation Review Project includes concepts such as the role of validation in the analytical procedure lifecycle and considerations for validation of multivariate analytical procedures (e.g., near-next-based analysis). infrared and Ramen spectroscopic analysis). There is a link to ICH Q14 where reference is made to how the results of the analytical method development will help design the validation study – as defined in the method validation protocol – and that there has more statistical considerations for evaluating data provided by validation.

The ICH Q14 project is a general guide covering the development of analytical procedures based on ICH Q8, Pharmaceutical Development, and ICH Q9, Principles of Quality Risk Management. The project complements ICH Q2(R2) and includes concepts on the development of multivariate and real-time release test procedures. Reference is made to both minimal and enhanced approaches to analytical method development where the enhanced approach results in the development of an analytical control strategy where one understands which analytical parameters need to be controlled, which is reflected in the system suitability test and (potentially) sample suitability assessment.

The draft guidelines introduce established conditions (ECs) for the analytical procedure (as per ICH Q12) where, together with an improved approach to the development of analytical methods, there is a better understanding of these ECs. There are also many guidelines related to lifecycle management and post-approval changes to test procedures that (still) see the benefit of an improved approach to analytical method development.

The ICH Q2(R2) revision and the new ICH Q14 guidelines will hopefully encourage companies to improve their analytical testing procedures and use modern technology rather than outdated and inefficient testing procedures. For more information on the potential impact of these new draft guidelines on your organization, contact Lachman Consultants online or by email: [email protected]

Paul Mason, Ph.D., is a Principal at Lachman Consultants who has over 20 years of experience in the pharmaceutical industry. He is an experienced quality control chemist in sterile oral solid, API and parenteral dosage forms. His experience spans finished dosage form, CMOs and manufacturing support for APIs (intermediates) within a quality control and analytical development framework.