Module 5 Presentations

05/07/2024

IMPD Pitfalls

Section(s) Appendices

Failing(s)

• TSE/BSE free declaration, certification or clarification on risk management not provided. • MA(IMP) only provided for final manufacturing site, not all manufacturing sites for DP. • Reconstitution steps not clearly defined as performed at site. • Differences between QP declaration manufacturing sites and IMPD stated sites. • EudraGMP MA/GMP summaries not always acceptable to RAs • Absence of GLP statements of compliance for pivotal (those required by ICH) studies • Brief details of the analytical assays used for PK and TK analyses, their limits and sensitivity not described.

Non-clinical

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Some Tips

• Don’t be scared to tackle the IMPD • Understand where you are in development and tailor your content • Do a gap analysis – Collate at the start all the guidelines you’ll need to reference, note key recommendations – Pull your content together – if anything obvious is missing get the ball rolling to have it provided • Wherever possible, reduce effort by referencing – pharmacopeial methods, other docs in the CTA – but only if they are going to be sufficient • Be prepared and unsurprised by questions – these are an opportunity to refine your approach and improve • Version carefully – it can quickly become complex to maintain an IMPD

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