The ICH plans to develop a new Quality Guideline, ICH Q14 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 BioPhorum member views have been gathered and published in BioPhorum feedback on ICH Q14 and Q2(R2)..
BioPhorum commends the committee on this initiative and was delighted to contribute to such an important discussion, however, from the BioPhorum team’s perspective, the current documents will not drive a consistent understanding of regulatory expectations and the provision of information by industry to regulators.
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) as the small molecule examples are not relevant in some key respects.
BioPhorum’s answers are based on the extensive knowledge of its members; their feedback therefore reflects their broad analytical expertize and pursuit of innovation.
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.