InstantGMP, Inc., together with the Botanical Education Alliance (BEA), hope to educate the kratom industry about FDA best practices to promote GMP compliant production for safe, effective, and quality products that consumers can trust.
Contact https://www.instantgmp.com/ and mention BEA for a discount on their software.
2018 has been a rollercoaster for the kratom industry. While producers and distributors enjoyed massive growth, the industry is under the microscope by the Food and Drug Administration (FDA) and consumers alike. Since the FDA’s purpose is to protect consumers, manufacturers must only sell products that are safe and of verifiable quality.
Good Manufacturing Practices (GMPs) are baseline standards set by the FDA that companies must comply with when producing or holding products for human consumption. The ambiguity and complexity of the regulations intimidate companies, but they do give businesses latitude to create their internal standards for compliance. There’s no “how to” for GMPs, but there are concepts to learn.
One of the core tenants of GMPs is a concept called Specifications. Specifications are internally established standards that ingredients must meet or exceed for production use. Specs test and measure attributes like purity, potency, composition, concentration, and strength. Many vendors provide a Certificate of Analysis (CoA) detailing information about an ingredient, but companies should further verify an ingredient’s quality through specs.
The purpose of specifications is to prevent substandard quality or contaminated ingredients from continuing through the supply chain. Documented results provide vendor traceability and a vital record in the event of a recall.
Another tenant of GMP compliance is strict documentation for batches. There are two types of records needed: Master Production Records (MPRs) and Batch Production Records (BPRs).
An MPR is a document containing a product’s recipe or formula, ingredients needed, step-by-step instructions, quality checks, and role-assigned personnel that review and approve batches. An MPR is akin to a checklist, and a BPR is the actual process of completing that checklist.
BPRs are generated from the MPR. This is where the production line operators check off steps, add ingredients where necessary, record results, perform in-process quality checks, and sign off when the batch is complete.
Sometimes too much of an ingredient is added, or a step is done incorrectly: these are examples of deviations. Mistakes happen, but the necessary action is to make sure deviations are noted in a BPR and addressed by quality assurance personnel. Since individual companies set standards, procedures should include steps for deviation resolution.
Admittedly, the ins and outs of GMPs and all the records necessary for compliance are cumbersome, especially for newcomers. GMP documentation is like the tax codes; only experienced tax professionals understand the details, so solutions like TurboTax exist to simplify and guide users. InstantGMP MES is an all-in-one batch management software that ensures GMP compliance with built-in workflows that is the TurboTax for FDA regulated industries.