9.1 - Records and Reports - Production Records Records & Recordkeeping Any physical plant you use

Any physical plant you use in the manufacture

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

microbiological testing

and records of all training and qualifications

construction

9.1 - Records and Reports - Production Records Records & Recordkeeping Any physical plant you 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