FDA’s Production Record Requirements

A master production record and a batch production record are two of the several important documents that a pharmaceutical manufacturer must maintain. They are indispensable parts of pharmaceutical current Good Manufacturing Practices (cGMPs), particularly FDA 21 CFR Parts 210 and 211. CFR Part 210 deals with the manufacturing, processing, and holding of drugs, while CFR Part 211 deals with finished pharmaceuticals.

Failure to comply with any regulation set forth in Parts 210 and 211 in the manufacture, processing, packing, or holding of a drug will render the drug to be adulterated, and the person who is responsible for the failure to comply will subject to regulatory action. It is critical that pharmaceutical manufacturers understand what the FDA requires in production records.

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Production Records: What the FDA Wants

To comply with FDA regulations, all cGMP manufacturers are required to keep master production records – also referred to as master batch records or master manufacturing records – and batch production records.

Master Production Records: Master production records are essentially written instructions for a specific manufacturing process, and the FDA requires a different master production record for each unique formulation and batch size. To ensure uniformity from batch to batch, master production records for each drug product must be prepared, dated, and signed by one person and checked, dated, and signed by a second person. The preparation of master production records must be described in a written procedure, and that written procedure must be followed. Master production records must also include nine key elements, including the name and strength of the product, a list of components, a statement of theoretical yield, and a description of product containers and packaging materials. (For full list, see FDA Sec. 211.186 Master production and control records.)

Batch Production Records: Batch production records are authentic copies of the master production record, used to document the specific information for each individual batch. According to the FDA, batch production records must be prepared for each batch of drug product produced and must include “an accurate reproduction of the appropriate master production or control record, checked for accuracy, dated, and signed.” Batch production records must also include complete documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished, including dates, equipment used, weights and measures of components, labeling control records, identification of individuals directly involved in each major step, and any investigation made, among other elements. (For full list, see FDA Sec. 211.188 Batch production and control records.)

Production Record Review: Before a batch is released or distributed, the quality control unit is charged with reviewing and approving all drug product production and control records, including those for packaging and labeling, for compliance. Any unexplained discrepancy, or the failure of a batch or any of the batch’s components to meet any of its specifications, must be investigated thoroughly. The investigation must extend to other batches that may have been associated with the failure or discrepancy in question, and a written record of the investigation, its conclusions, and follow-up must be made. (See FDA Sec. 211.192 Production record review. for more on this.)

Additional Records for 21 CFR Part 211: In addition to the production records described above, 21 CFR Part 211 requires other records and reports: equipment cleaning and use log; component, drug product container, closure, and labeling records; laboratory records; distribution records; and complaint files.

Benefits of Automating Processes Relating to Production Records

Benefits of automating master production records and batch production records include both compliance improvements and operational efficiencies, including:

  • Error Reduction – An automated batch record system can significantly reduce the likelihood of errors being recorded on a batch record, which is a common problem with manual systems.

  • Real-time Visibility – An electronic system can provide real-time data, visibility, and traceability into manufacturing operations and processes, including quality events and corrective actions.

  • Enforced Compliance – An electronic system can automatically track and enforce training, and ensure operators follow prescribed procedures to meet FDA requirements.

  • Greater Efficiency – An automated system can eliminate manual inefficiencies, streamline processes, and easily compile data from across different departments and locations.

Learn More About Production Records in Pharmaceutical cGMPs

To find out how MasterControl can help address your production record needs, contact a MasterControl representative.