BioPhorum feedback on ICH Q14 and Q2(R2)

The ICH plans to develop a new Quality Guideline, ICH Q14 on Analytical Procedure Development, and revise the ICH Q2(R1) Guideline on Validation of Analytical Procedures, to potentially combine both documents into one for simplification and clarity.

The ICH has asked for industry comments as part of the documents’ public consultation, and our views have been gathered and published in this paper.

Overall, the first-draft guidelines seen by the team need to be less detailed in the main body of the documents but more specific to analytical methods. The documents must also be consistent throughout (across Q14 and Q2 and between the main body texts and examples). Further, detailed examples are needed for modalities other than small molecules (e.g., biologics, cell and gene therapies, etc.) as the small molecule examples are not relevant in some key respects.

In the view of the BioPhorum team, the current documents will not drive a consistent understanding of regulatory expectations and the provision of information by industry to regulators.

BioPhorum’s in-depth feedback includes more than 80 line-by-line, detailed comments, including the rationale for the points and any proposed changes/recommendations that are deemed necessary by the team to ensure a harmonized implementation across industry and regulatory agencies.

Some other points of feedback include a lack of guidelines for analytical standards definition and their comparability for large molecules, hybrid approaches to method development, and the regulatory relief that can be expected from the approach for post-approval changes.