Spring Intro 2023

03/03/2023

• Manufacture (Manufacturer, Batch Formula, Description of Manufacturing Process/IPCs, Control of Critical Steps and Intermediates, Process Validation and/or Evaluation) Common Deficiencies – 3.2.P.3 (ctd.)

• Process validation scheme not provided • Non-standard process – 3 full/commercial scale batches needed

EMA/CHMP/CVMP/QWP/BWP/70278/2012 - Guideline on process validation for finished products - information and data to be provided in regulatory submissions the finished in regulatory submissions dosage form

03/03/2023

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Common Deficiencies – 3.2.P.4

• Control of excipients (Specifications, Novel excipients)

– TSE –Certificates or relevant statements from the suppliers of suspect excipients not submitted – Expired TSE CEPs submitted. – Excipient monographed in Ph. Eur., but reference made to USP/other pharmacopoeia monograph (for non-harmonised monographs) – Functionality related characteristics (FRCs) – Ph. Eur. Chapter 5.15 – Certain excipient attributes, such as the particle size of an excipient intended for a

solid dosage form or the molecular mass of a polymeric material used as a viscosity-increasing agent, may relate to functionality in a more general sense. When the pharmaceutical development work of a specific product has identified the existence of one or more critical FRCs for an excipient, they are considered to be CQAs for that excipient and should be controlled accordingly.

03/03/2023

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