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and drug products designed to ensure that each lot number conforms to appropriate standards of identity
internal audits
pending the appropriate sampling
name and address of the consignee
There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components
USP 61 Total Yeast and Mold Count stability testing and drug products designed toSOP for determining the TYMC, the quantity of yeasts, mould or mold, and fungi that will grow on Sabouraud Dextrose Agar SDA plates according to USP <61> and EP 2. 6. 12 and to limits specified in USP <1111> and EP 5. 1. 4
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