Spring Intro 2023

03/03/2023

Common Deficiencies – 3.2.P.7

• Container closure system (Primary/Secondary)

– No confirmation of compliance of the immediate packaging material with the Ph. Eur. and the relevant EU directive. – No CE mark confirmation for medical devices which accompany product – Rubber stoppers (vials) – no confirmation they comply with Ph. Eur. 3.2.9. – ‘Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders’. – Measuring device in view of the posology not appropriate, • e.g. a spoon proposed, but a graduated dropper would be more appropriate. • 5ml syringe presented in 3.2.P.7 is divided into 1ml graduations with further annotated sub-divisions of 0.2ml. As the dosage involves dosing of 1.25ml, 2.5ml and 3.75ml the presented syringe is inappropriate .

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• Stability (Protocol, Data Evaluation, Photostability, Forced Degradation/Stress Testing) Common Deficiencies – 3.2.P.8

• No justification for including more stringent storage conditions, e.g.  “Do not refrigerate and /or freeze” • No justification for omission of photostability study. • Widening of shelf-life specification not supported by stability data – tightening achievable • No comments on OOS results • No batch size/number/packaging material/site of manufacture described • No indication which stability batches have been manufactured with which source of active ingredient. • No acceptable mass balance found between assay of API and impurities/degradants

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