News about GMP/cGMP


EMA: Comments on Draft ICH Q2(R2) and ICH Q14 Published

EMA: Comments on Draft ICH Q2(R2) and ICH Q14 Published

On 24 August 2022 the EMA (European Medicines Agency) published a 72-pages strong overview on the comments received as feedback on the draft of ICH Q2 Validation of analytical procedures along with a 54-pages PDF on comments made regarding the draft of ICH Q14 Analytical procedure development. The volume of the documents indicates the large number of comments that were submitted.

The overall intention of the revision:
Both guidelines should jointly describe the development and validation activities that should be applied during the life cycle of an analytical procedure to assess the quality of medicinal substances and products. It should, therefore, be made easier for manufacturers to switch between analytical testing methods and support in establishing robust analytical processes (we reported).

To name some small snippets:
The European Federation of Pharmaceutical Industries and Associations (EFPIA) considers the ICH Q14 guidance as a reasonable framework but short on content for communicating enhanced knowledge in a submission. EFPIA mentions, that training case studies could help to align the expectations between industry and regulatory authorities. Another question is if the approach is still acceptable, to handle an analytical transfer from the site of validation to an additional testing site is under GMP and not describe it in a regulatory submission

Others, especially smaller companies comment on the difficulties they would have to implement an enhanced approach to method validation, considered limited time and personnel resources. Another topic is the alignment between the two guidelines, which is considered insufficient. Cross-referencing should be enhanced, and some terms should be used more consistently.

Meanwhile, the US FDA has also released ICH Q14/Q2(R2)-drafts for comment. A finalisation of the guidelines is planned for May 2023.


EMA: ICH Q2(R2) Validation of analytical procedures

EMA: ICH Q14 Analytical procedure development