9.1 - Records and Reports - Production Records Records & Recordkeeping You must identify and use

You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required

There should be adequate suitable storage space for samples and records

construction

Any physical plant you use in the manufacture

such written procedures shall be followed

9.1 - Records and Reports - Production Records Records & Recordkeeping You must identify and useTo 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