General, Specific Comments on FDA Comparability Guidance
Boehringer Ingelheim says that while the main purpose of an FDA draft guidance on chemistry, manufacturing, and controls information in comparability protocols for human drugs and biologics is well stated in the draft’s introduction and background sections, it loses focus in its content recommendations. The company’s comment letter says that a comparability protocol has the potential to be a “key enabler” of the goal shared by FDA and the company to foster a robust supply chain, and enable an agile pharmaceutical manufacturing sector that can readily respond to change, and adapt and overcome issues, whether external or internal, that have the potential to disrupt the supply chain.
GlaxoSmithKline says that since the draft is clearly linked to the ongoing development and adoption of a new International Conference on Harmonization (ICH) guidance on technical and regulatory considerations for pharmaceutical product lifestyle management, FDA should not finalize its guidance update until after the ICH guidance has been completed and adopted.
The Biotechnology Innovation Organization says the draft is “thorough and well-considered. It takes into account several approaches to utilizing change protocols for post-approval changes.” It suggests that the draft should state that content requirements should follow the current common technical document format, and also calls for harmonization with the ICH guidance.
The Generic Pharmaceutical Association says that the draft “provides adequate flexibility to address the diverse needs of our industry.”