Spring Intro 2023

03/03/2023

Module 3 – 3.2.P Drug Product

1. Description and Composition 2. Pharmaceutical development (Drug Substance, Excipients, Formulation & Manufacturing Process Development, Overage vs. Overfill, Container Closure Suitability) 3. Manufacture (Manufacturer, Batch Formula, Description of Manufacturing Process/IPCs, Control of Critical Steps and Intermediates, Process Validation and/or Evaluation) 4. Control of excipients (Specifications, Novel excipients) 5. Control of drug product (Specifications/Justification, Analytical Procedures/Validation, Batch Analyses) 6. Reference standards 7. Container closure system (Primary/Secondary) 8. Stability (Protocol, Data Evaluation, Photostability, Forced Degradation/Stress Testing)

03/03/2023

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Common Deficiencies

• Overall steady improvement in both submission of MAAs (applicants) and assessment (Ras) has been seen – Satisfaction levels with the content of the submitted dossiers and responses to questions, as rated by rapporteurs, were moderate to very good ; a non-negligible proportion of the dossiers were considered not mature enough or it was difficult to locate information. However, the presentation of the application in general (ease of locating information, use of hyperlinks) and the need for consistency between application form, PI and the dossier submitted remains a problem; the latter could reduce the number of administrative validation issues. Increased awareness of the pre-authorisation guidance, enhanced adherence to the guidelines and better substantiation of the data and subsequently in the responses during the evaluation are areas that would also benefit from improvement. The need for mature dossiers and responses during the evaluation is very important, as late submission of large datasets renders the finalisation of the procedure challenging. - Why is this?

03/03/2023

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