FDA requires that supplement manufacturers prepare and follow a written Master Batch Record (MBR), also referred to as a Master Manufacturing Record (MMR) or Master Production Record (MPR). MBRs are essentially written instructions for a specific manufacturing process. FDA requires a different MBR for each unique formulation and batch size of a dietary supplement.

Documentation showing that batches were properly made and that quality control personnel performed their review and disposition of products at the time of manufacturing are also expected. This ensures uniformity in the finished product from batch to batch.  It also ensures that the proper ingredients are added and that each processing step is completed according to an established procedure.

For example, the blending processes for each dietary supplement product may be different depending on the time or the agitation speed needed to get the best possible blend.

In 2014, more than 10% of 483s stemmed from issues with MBRs. Common problems found by FDA inspectors of dietary supplement manufacturers center on incomplete batch records, defining unique batches and a lack of corrective action plans. The FDA expects MBRs to include:

• A list of ingredients and amounts
• Identification of equipment
• Verification of cleaning and calibration
• Lot numbers and other control information
• Testing activities and results (Specifications)
• Use of labels
• Quality approvals
• Signatures
• Tips for GMP Compliant Master Batch Records

InstantGMP and regulatory expert Marian Boardley will present a webinar expounding on common issues with MBRs. The webinar will feature real incidents, how to avoid them and be in compliance with FDA regulations. Tips for Compliant Master Batch Records takes place on Tuesday, April 21 at 1 pm EST. The cost to attend is $25. Interested parties can register via Eventbrite.

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InstantGMP, Inc. develops cloud-based electronic batch record software and SOPs that reinforce Good Manufacturing Practices. These software systems were developed to meet standards specific to the pharmaceutical industry and were recently updated for the Dietary Supplement industry.