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prioritized by risk assessment
Regular periodic or rolling quality reviews of all authorised medicinal products should be conducted with the objective of verifying the consistency of the existing process
comply with applicable Federal
including its identity
in-process materials
8.0 - Master Manufacturing Record 111.170 prioritized by risk assessmentYou must prepare and follow a written manufacturing record (MMR) for each unique formulation and batch size of dietary supplement that you manufacture, including its identity, purity, strength, composition, lot number, overage, and yield, to ensure uniformity in every finished batch and that it meets its specification