CRED Getting the CMC Dossier Right 2024

28/08/2024

ICH Q6A General Concepts

• Following concepts could be helpful when setting specifications, if justified and accepted • Periodic / skip testing • Release vs. shelf-life acceptance criteria • In-process tests • Design and development considerations • Limited data available at filing • Parametric/real-time release testing • Alternative procedures • Pharmacopoeial tests and acceptance criteria • Evolving technologies • Impact of DS specification on FPS • Reference standard

The Organisation for Professionals in Regulatory Affairs

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Periodic/skip testing

• Performing specified tests at release on pre-selected batches and/or pre-determined intervals

• Batches must still meet all specification acceptance criteria, if tested

• Less than full specification testing must be presented and justified to the regulatory authority for approval prior to implementation

• Limited data at initial filing may restrict periodic/skip testing to post-approval • Prior knowledge/experience as justification

• Regulatory Authorities should be notified of failures • Batch-by-batch reinstated if demonstrated by data • Examples include tests for: • Residual solvents • Microbiological quality in solid dosage forms

The Organisation for Professionals in Regulatory Affairs

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