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container damage or broken seals
such written procedures shall be followed
microbiological testing
and records of all training and qualifications
9.1 - Records and Reports - Production Records Records & Recordkeeping container damage or broken sealsTo assure uniformity from batch to batch, master production and control records for each drug product and batch size, shall be prepared, dated, and signed; often referred to as the MMR. A completed batch production and control record shall be prepared for each batch of drug product produced from an accurate reproduction of the MMR
US$ 1400.00
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