Sub-Part F - Production & Process Controls

6.2 - Production - Manufacturing Operations

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Each batch of drug product must be manufactured with the intent to provide not less than 100 % of the labelled or established amount of active ingredient with a completed Batch Processing Record containing a record of the manufacturing formula and processing instructions, completed at the time of performance.

Fermentation icons created by LAFS - Flaticon
Large stainless steel pharmaceutical mixing vessel with a round sight glass and an amber coloured liquid inside mixing with foam