FDA Requirements for Master Batch Records

Common Terms and Requirements Relating to Master Batch Lot History Records.

To comply with FDA regulations, such as 21 CFR Parts 210, 211, and 820, current Good Manufacturing Practices (cGMPs) manufacturers are required to keep master batch records – also referred to as master production records or master manufacturing records – and batch production records.

It’s important to understand the terms commonly associated with batch records and device history records and to understand how they fit together.

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Master Batch Lot History Records: Common Terms and Requirements

    1. Batch Production Record: Accurate reproduction of the master batch record, used to document specific information relating to the production and control of each drug product batch. According to FDA 21 CFR 211, batch production records must include: dates; identity of individual major equipment and lines used; identification of each batch of component or in-process material used; weights and measures of components used; in-process and laboratory control results; inspections of packaging and labeling areas; actual yield and percentage of theoretical yield; complete labeling control records, including specimens or copies; description of drug product containers and closures; sampling performed; identification of individuals directly involved in each major step; any investigation made; and results of examinations.
    2. Device History Record: Compilation of all records from the manufacture of a particular finished product, with the purpose of demonstrating that a device has been produced in accordance with its device master record. According to FDA 21 CFR 820, each device history record must include, or refer to the location of: dates of manufacture; quantity manufactured; quantity released for distribution; acceptance records; labeling information used for each production unit; and device identifications and control numbers used. In some instances, a device history record may be synonymous with a lot history record.
    3. Device Master Record: Summary of all instructions and specifications involved in the production of a product from start to end. Device master records contain all information needed to produce the device, centralizing a record of the entire production process. According to FDA 21 CFR 820, each device master record must include, or refer to the location of: device specifications; production process specifications; quality assurance procedures and specifications; packaging and labeling specifications; and installation, maintenance, and servicing procedures and methods.
    4. Lot History Record: Compilation of documentation of a particular production lot. The lot history record authorizes and controls the production of a single lot of components or finished devices. The lot history record may include documentation of the processes, the material certifications, the finishing certifications, and the lot inspection records, among other quality assurance documents pertinent to a particular lot. When completed, the LHRs required to manufacture a finished device comprise the device history record.
    5. Master Batch Record, or Master Manufacturing Record: Essentially written instructions for a specific manufacturing process, required for each unique formulation and batch size. According to FDA 21 CFR 211, master batch records for each drug product must be prepared, dated, and signed by one person and then checked, dated, and signed by a second person to ensure uniformity from batch to batch. Master manufacturing records must also include nine key data points, including: the name and strength of the product; a list of components; a statement of theoretical yield; a description of product containers and packaging materials; and complete manufacturing and control instructions.
    6. Traveler: Manufacturing or shop travelers track what products need to be created and what steps are needed using specific procedures and materials. Travelers are typically printed and travel with the job as each production step occurs, tracking the status of operations in the manufacturing process and the activities performed by workers. Data included in a traveler may include: outputs; sequential listing of required tasks; special work instructions and procedures; in-process inspection and test requirements; and individual part data.