Spring Intro 2023

28/03/2023

3.2.P Drug Product

3.2.P.6 Reference standards or materials • The Certificates of Analysis (COA) for the Active Pharmaceutical Ingredient (API) working reference standard should fully comply with the API specifications • e.g., if the API is compendial, the working standard must be tested to compendia. • COAs for all impurity reference standards used during the validation and required for routine testing should be provided.

3.2.P.7 Container closure system • Identity and specification of each primary packaging component. • For Parenteral products, CCIT required

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Drug product stability

Complex molecules prefer to exist in a simpler state Energy input required to synthesise, will break down over time • Reduced efficacy due to loss of potency • Potential toxicity from decomposition products Drug substances are generally less stable when formulated as a drug product than in the unaltered chemical/biological state Excipients may accelerate degradation and may also impact analytical methods Key considerations for drug product stability: • Demonstrate that formulation is optimised to preserve DS stability • Demonstrate that product has acceptable potency within reasonable shelf life • Demonstrate that degradation pathways are known, decomposition products are identified, analytical methods are suitable and mass balance exists

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