Episode 3: Best Practices for Dietary Supplement Operations

The Master Manufacturing Record

The Master Manufacturing Record, or MMR is the critical component of a dietary supplement program. The requirement for the MMR is found in section K of 21 CFR 111, and it is the main set of information that the quality team must compile each time supplements are processed in a facility.

But what is in a master manufacturing record and how do we put one together?

The MMR of a dietary supplement facility is the collected monitoring information for each production run.  This includes the pre-operative checks for cleaning, reviews of the safety and potency of ingredients used in production, hygienic practices, chemical controls, foreign object controls, production inspections, test results and quality checks, and then finally a review of conformance for all of those records.

Pre-operative Checks

Because we have a significant amount of records that must be kept as part of operations, it is essential that a facility processing or packaging dietary supplements start with establishing checks throughout each production run. At the start of each production run, we must have a pre-operative check for cleanliness in production areas and equipment.

The person performing the action cannot also sign off on conformance. That means two people per action. The person performing the cleaning and the person signing off that it was completed. Then separately, the person performing the preoperative inspection and the person signing off that preoperative inspection was completed.

Ingredient Checks and Operational Checks

Once cleaning and preoperative inspection are completed and documented in the MMR, we also need to have checks of the ingredients.
Each ingredient must be inspected for authenticity, potency and safety for each batch. We can accomplish this in one of a few key ways, but it is absolutely required that a check of ingredients be recorded as part of the MMR for each batch.
Ingredients should be further checked at key operational points to assure that process steps are completed as expected, and that the composition of supplements maintain integrity throughout the process

Pre-shipment Review

With the in-process checks, and any metal detection or x-ray checks completed as required within the MMR, a master verification of all these checks is the final requirement. This is generally referred to as a pre-shipment review of records.
A pre-shipment review should be performed after operations have completed for each batch, and does not need to be performed directly prior to loading shipping vehicles.

Best Practice Summary

Where a facility is able to incorporate all of the regulatory requirements found in episode 2, as well as the best practices and MMR requirements covered in this episode, the dietary supplement operations should be well on its way to meeting all regulatory and customer expectations.

Free Manufacturing Master Record Checklist Download

If you would like to discuss having Kellerman Consulting write and implement your food safety and quality management system program, contact us for a free consultation.