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Good Manufacturing Practices, better known as GMPs, are a system of minimum requirements set by the Food & Drug Administration (FDA) to ensure safe products of consistent quality. However, they can be intimidating to many due to their complexity. Each FDA-regulated industry features its own standards for GMP compliance, but they all have several things in common.
The FDA created GMPs to protect consumers from unsafe products. Basic obligations for GMP compliance include manufacturing in a clean and controlled environment and being prepared for a recall. Most importantly, GMPs mandate that records are kept covering the who, what, where, when, and how of production. This means that producers need to document:
- Ingredient sources
- Ingredient characteristics (purity, potency, composition, concentration, and strength)
- The product to be produced
- The product’s recipe or formula
- Steps to take in production
- Designated personnel (personnel must be trained)
- In-process quality control measures
GMP Recordkeeping: Master Records vs. Batch Records
The best way to explain Master Production Records (MPRs) is to equate it to a cooking recipe. A recipe contains measured amounts of ingredients, what tools are needed, what steps must be taken, and what the result should look like.
Batch Production Records (BPRs), guided by an MPR, are where batch information is recorded. BPRs document actions taken before, during, and after production for an individual batch — which ingredient was used and its quantity, what tools were used and for what purpose, and which steps were followed. Personnel must verify all documentation in the form of signatures.
However, sometimes people make mistakes. In GMPs, this is called a deviation. Deviations aren’t necessarily problematic, but need to be documented and dealt with in some way. For example, someone was heavy handed in using chocolate chips for a cookie recipe. The cookie making can continue if the extra amount is recorded and Quality Assurance (QA) signed off that extra chocolate chips won’t affect that batch’s quality. If it does affect the batch’s quality, QA can reject that batch and start over.
Why is GMP important for the Kratom Community?
Now, more than ever, Kratom companies need to become familiar with GMPs and what’s required for compliance. MPRs and BPRs are like filing taxes in that they’re a necessary part of doing business. Keep all receipts from vendors, write out recipes/formulas, and meticulously record all manufacturing-related activities, which can be simplified using cloud-based electronic batch record software. GMP compliance assures your customers safe, high-quality products, while protecting and preparing your business in case of a problem.
GMP compliance does not come overnight, but some steps can be taken now to lay the foundation. That’s why the Kratom Trade Association (KTA) and InstantGMP, Inc. are partnering to educate Kratom manufacturers and distributors about GMP best practices. Over the next several months, we will roll out KTA’s new GMP guidelines and an education series to help members manage their products, streamline manufacturing, and improve overall product quality and consistency.
This post is also available on the KTA’s blog page. Visit KratomTrade.org/gmp for resources and information, sign up for email alerts, and follow us on Facebook and Twitter for updates on our GMP webinar on September 25 and other new content!