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Current Good Manufacturing Practices (cGMPs) for Dietary Supplements

Representing FDA’s set of standards for dietary supplements that every manufacturer must follow, cGMPs help safeguard against potential contamination, errors, mix ups, deviations, and failures.

FDA set forth cGMPs as a set of regulations that manufacturers and packagers of dietary supplements must proactively use. Current Good Manufacturing Practices act as a guarantee that registered products are not only effective, but also safe and pure.

A strong cGMP strategy is essential in maintaining FDA compliance. Master Manufacturing Records are critical parts of that cGMP strategy and act as that guarantee.

From batch to batch, MMRs identify individual steps in the manufacturing process for each supplement, ensuring overall consistency in the components, quality, labeling, and packaging.

How Registrar Corp Can Empower FDA Compliance

To obtain FDA compliance, dietary supplement suppliers are required to follow Current Good Manufacturing Practices. This includes the writing and implementation of MMRs for each and every unique formulation and batch size of dietary supplements they bring to market.

MMRs can take a great deal of time, resources, and a keen understanding of the requirements to ensure that documentation is completed and followed properly.

Registrar Corp’s team of regulatory specialists make it easier than ever to navigate the complex MMR and cGMP compliance process. We will review your Master Manufacturing Records for completeness so that your MMR is FDA compliant.

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Get assistance with MMR services.

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  • Max. file size: 50 MB.

Frequently Asked Questions

Master Manufacturing Records (MMRs) are the compilation of records containing the procedures and details for manufacturing a finished supplement. MMRs are often prepared as a single document, as a file, or may be prepared using an index system that points to the location and ID of pertinent files, records, and other documents that comprise the MMR.

The Dietary Supplement CGMP rule, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111) establishes specific requirements for this documentation.  Please refer to 21 CFR 111.210 for the complete requirements. 

A written master manufacturing record is required for each unique formulation of dietary supplement manufactured, and for each batch size, to ensure uniformity in the finished batch.   

You can expect FDA to review the master manufacturing record and determine whether it contains required information and identifies appropriate specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement. 

The failure to prepare and follow a written master manufacturing record would be considered a serious violation of the dietary supplement regulation (21 CFR 111) and could lead to regulatory action. 

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