A review of warning letters revealed that there is a wide-spread lack of Master Manufacturing Record (MMR) documentation at Dietary Supplement producers. The FDA has found problems in many master records where there have been failures to establish specifications for the identity of the components especially dietary ingredients, for purity and prevention of adulteration, strength or assay value, composition, and for limits on contaminants. They has also firms with adequately established MMRs who failed to meet specifications, to qualify their suppliers, and who failed to record completion of steps and resulting outcomes.

If FDA inspectors find compliance issues during their inspection, they will issue a Form 483 citation. If the issues are not resolved, the FDA can then issue a Warning Letter. An example is in the Warning Letter sent to United Nutrition Labs, Inc in July 2012. The FDA found many GMP violations including the failure to record changes in manufacturing that did not comply with their Master Manufacturing Records. There have been warning letters issued to other companies who failed to keep proper documentation of the steps used for their manufacturing processes or for not recording the outcomes of their manufacturing steps.

Why Master Manufacturing Records are important:

The Dietary Supplement Health and Education ACT spells out the requirements for producing dietary supplements. It requires that manufacturers prepare and follow a separate written MMR for each unique formulation and each batch size of dietary supplement produced. The result is uniform batch to batch production of finished products. It ensures that the proper ingredients are added and that each processing step is completed according to an established procedure. Proper use of MMRs can help avoid potential problems, for example in the the blending process. A dietary supplement product might come out differently if there are varied mixing times or agitation speeds where a specific time or speed is necessary for the best possible blend.

The MMR can be used to identify the specifications for each place in the manufacturing process where control is necessary for ensuring the ultimate quality of the finished dietary supplement product. The FDA found that When Master Manufacturing Records were not used, critical steps were not actively controlled and operators left out important ingredients during formulation. These are serious risks which could lead to compromised quality. Every firm strives to provide their customers with the highest quality product possible. Using a well-defined Master Manufacturing Record is essential to maximizing quality and minimizing the possibility of errors.

How to improve Master Manufacturing Record compliance:

Each MMR needs to include the amount or measure of each dietary ingredient and each component that will go into the product. This will keep employees from adjusting the amounts of ingredients from memory or based upon ratios learned from other employees. MMRs should specify the equipment to be used to ensure the equipment is of an appropriate design. The master record should require that equipment cleaning is checked to make sure its use will not result in the contamination of the dietary supplement.

Each MMR should include:

– A complete list of components to be used in the batch

– An accurate statement of the weight or measure of each component to be used

– The identity and weight or measure of each dietary ingredient

– A statement of theoretical yield at each step of the manufacturing process where control is needed to ensure quality of the finished product

– The expected yield of the finished batch

– Written instructions, including specifications, at every place in the manufacturing steps where control is needed to ensure final product quality

– Procedures for sampling

– Written instructions for manual operations

– Prompts for signing and verifying that steps were completed;for example, one person to add and another person to verify the addition of the components

The InstantGMP-Lite EBR makes generating Master Manufacturing Records easy. This electronic batch records software automatically keeps track of each MMR and each version of the MMRs as updates are needed. Individual steps can be defined in detail so operators will know exactly what actions to take, what controls are necessary at each step and what range of action is acceptable. This web-based application runs through any internet browser. It allows authors and quality assurance to collaborate online to write and to approve each MMR. All of the compliance requirements are built into the software so it’s easy to meet GMP requirements with this application.

Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Rick Soltero, President of http://www.InstantGMP.com, designed this electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed http://www.InstantGMP-Lite.com, an electronic batch record system for cGMP manufacturing. These make staying in compliance easy.

Author Bio: Rick Soltero, President of InstantGMP designed an electronic manufacturing execution system that is cloud based and Part 11 compliant. He also developed InstantGMP-Lite, an electronic batch record system for cGMP manufacturing. These make staying in GMP compliance easy.

Category: Wellness, Fitness and Diet
Keywords: GMP Compliance, Dietary Supplements, Manufacturing Execution Software, Electronic Batch Record