There are a number of examples where the FDA found batch record violations that ultimately resulted in them issuing a Warning Letter. Milk Specialties Global, a dietary supplement company, received a FDA warning letter after an inspection of their plant in Wautoma, Wisconsin. The company was cited by the FDA for keeping incomplete batch records of the supplements and for failure to document their decision making process when production steps deviated from requirements. Similarly, Prismic Light International was inspected and consequently cited for failure to create a batch record for every batch produced. In New England, NatureMost was cited for failure to include the following information in their batch production records:

– Detailed records of the cleaning, maintenance, and sanitation of processing lines and equipment used in batch production, or a cross-reference to where the records or logs were kept

– Confirmation documents showing final dietary supplements met specifications

– Packaging and labeling documentation during operations

– Documentation of quality reviews of material reviews or of dispositions

Importance of Batch Production Records

Manufacturers and packagers of dietary products are required to maintain production records to prove they made their products in accordance with good manufacturing practices (GMP). They should be documenting production times, the raw materials and dietary ingredients used, that final products were made according to specification and the master manufacturing formula, and that nonconformities were inspected and fixed. In order to produce uniform batches which meet quality requirements and specifications, these requirements must be followed. This way, if a problem arises or a customer has a complaint, records will be available to be reviewed and issues resolved. Batch records should be complete and thorough, and include all raw materials components that go into the batch so that if problems arise, it will be simple to find the cause and to avoid the problem moving forward.

Improving cGMP Compliance

BPR must include the following information to be within cGMP requirements:

– Identification of the equipment and processing lines used in batch production

– Documentation showing maintenance and cleaning times and dates, or references to where this information is kept

– Records of equipment cleaning and processing line sanitation for those that are used in batch production, or cross-referencing to their logs

– All of the components used in the batch with their identities confirmed and their weights or measures recorded

– Theoretical percentage yields during different phases of processing and the final yield results

– Signatures or initials of production operators and personnel in charge of weighing or measuring components for batch each time they weigh out or measure a component

– Verification of correct weights and measures of components by a second party

– The quantity of packaging and labels, and the identifier assigned during packing and labeling operations

– A record of quality control personnel reviewing the BPR and proof of approval or rejection for reprocessing or repackaging, and for batch distribution

– Documentation of material reviews and disposition decisions

– The actual results which were obtained during the monitoring of the operation (i.e., in-process testing)

– Final results showing the product met or didn\’t meet specifications

InstantGMP-Lite EBR is an electronic batch record software system that makes it easy to keep track of Master records and executed Batch Production Records. The software runs through a unique secure database on the web which provides instant access to data and processes anytime, anywhere.

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