ICH adopts guidelines on viral safety evaluation and analytical method development

The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as well as a guideline on validating analytical procedures Q2(R2) and a complementary Q14 guideline that aims to harmonize the scientific approaches for analytical method development.

These developments were announced following its 31 October meeting in Prague. All three were adopted as Step 4 documents but have not yet been released on the ICH website. These guidelines now go to regulators for implementation.

ICH released the Step 2 draft document of Q5A(R2) for public consultation in October 2022. (RELATED: ICH advances guidelines on selective reporting of safety data, viral safety, Regulatory Focus 11 October 2022).

The Q5A(R2) guideline “retains key principles of the original Guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products.”

US pharmaceutical industry groups endorsed the major principles of the draft Q5A(R2) guideline in their comments but said it could be improved by incorporating continuous manufacturing principles and by clarifying its recommendations on materials testing (RELATED: Pharma groups say ICH guideline on viral safety evaluation needs to incorporate continuous manufacturing, Regulatory Focus 19 January 2023).

ICH also adopted the ICH Q2(R2) and ICH Q14 guidelines, which were released as drafts in March 2022 (RELATED: ICH releases draft guidelines on analytical method development, Regulatory Focus 31 March 2022).

The Q14 guideline would harmonize the scientific approaches for analytical procedures development, while the Q2(R2) document addresses the validation principles for using analytical procedures such as near-infrared (NIR)-based analysis and Raman spectroscopy, which often require multivariate statistical analyses.

ICH said the Q14 guideline aims to “improve regulatory communication between industry and regulators and facilitate more efficient, sound scientific and risk-based approval as well as post-approval change management of analytical procedures.”

An Expert Working Group (EWG) will now transition to an Implementation Working Group (IWG) to develop training materials for both guidelines.

In other activities, ICH will launch an independent third-party survey to gauge the level of implementation of ICH guidelines among its members in December. The objective of the survey is to “inform the ICH Management Committee elections in June 2024” and to spot training and capacity building needs.

ICH also announced that a Memorandum of Understanding (MOU) has been signed with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) to enable both groups to collaborate on ICH guidelines that are also relevant to PIC/S inspectorate activities. PIC/S has been an ICH observer since 2017.

ICH also noted continuing growth in the Medical Dictionary for Regulatory Activities (MedDRA) with the addition of over 600 subscribers since January; the product is now used in 138 countries. ICH also resumed in-person MedDRA training this year, with a growing number of classes held in Brazil and China. MedDRA is now available in 20 languages and recently added Arabic and Estonian.

ICH also announced the addition of a new member, Hong Kong’s Pharmacy and Poisons Board (PPBHK).

The next ICH meeting will be held in Fukuoka, Japan, on 4 June 2024.

ICH

ICH adopts guidelines on viral safety evaluation and analytical method development

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