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such written procedures shall be followed
container damage or broken seals
and expiration dates
You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required
9.1 - Records and Reports - Production Records Records & Recordkeeping such written procedures shall beTo 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
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