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

Any physical plant you use in the manufacture

and records of all training and qualifications

construction

There should be adequate suitable storage space for samples and records

if shelf life dating is used

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