9.1 - Records and Reports - Production Records Records & Recordkeeping container damage or broken seals

container damage or broken seals

construction

or holding of a drug product shall have education

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

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