CRED Getting the CMC Dossier Right 2024

28/08/2024

Pharmacopoeial Tests and Acceptance Criteria

• Pharmacopoeial tests and acceptance criteria should be used whenever possible

• ICH Q4B process for harmonization of tests and acceptance criteria • Pharmacopoeias may align outside of Q4B process

Residue on Ignition/Sulphated Ash

Dissolution

Extractable Volume

Sterility Test

Particulate Contamination: Sub-visible particles

Tablet Friability

Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use

Polyacrylamide Gel Electrophoresis

Capillary Electrophoresis

Analytical Sieving

Disintegration

Bulk Density of Powders

Uniformity of Dosage Units

Bacterial Endotoxins

The Organisation for Professionals in Regulatory Affairs

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Impact of Drug Substance on FPS

• CQAs that are uniquely associated with the DS should not be included in the FPS

Example include testing for: • Impurities related to the DS synthesis that are not degradation products

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The Organisation for Professionals in Regulatory Affairs

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