Spring Intro 2023

03/03/2023

• Pharmaceutical development (Drug Substance, Excipients, Formulation & Manufacturing Process Development, Overage vs. Overfill, Container Closure Suitability) • Huge amount of either unnecessary data submitted or data submitted has not presented in logical way • From lab to production line • No dissolution testing submitted for batches used in clinical trials • No comparative dissolution testing submitted for batches used in the clinical trials vs. bioequivalence test vs. the brand • No comparative impurity determination of the generic product with the brand • No justification for chosen dissolution speed, e.g. 75 rpm • Age of the product used for preservative efficacy testing missing • (should be indicated and preservative efficacy testing should be performed on product at or close to the end of the proposed shelf life) Common Deficiencies – 3.2.P.2

03/03/2023

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Common Deficiencies – 3.2.P.2 (ctd.) • Pharmaceutical development (Drug Substance, Excipients, Formulation & Manufacturing Process Development, Overage vs. Overfill, Container Closure Suitability) • No justification for the addition of preservative / antioxidant to prevent oxidative degradation of the active substance  under stress conditions the active substance did not show sensitivity to oxidation (Refer to the 3.2.S / ASMF!)  US vs EU? • Manufacturing Process Development  Decision tree for selection of sterilisation method not followed (no justification given for chosen sterilisation method)  CPPs / CQAs not incorporated in the manufacturing process (IPCs/ critical parameters/operating conditions)

03/03/2023

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