A VERY common question the BEA receives is:
Here is an answer directly from Angela Watson, our co-founder and board member of the BEA (since 2011). Angela has been helping lead the charge towards GMP for the past half-decade and is a bona fide expert in this topic. Vendors, please listen up because this is KEY information to help you get to where you want to be.
Regular kratom consumers – if you want your vendor to be GMP please share this post with them!
There is no law requiring any classes for GMP. There is a requirement to show that each of your staff has been trained to do his or her job and how that job ties into GMP, especially in the case of your lab reports.
The classes are a suggestion so that people can implement the GMP practices. No class will give you everything you need as they are general overviews and will not be specific to your organization.
The best value right now is to join AHPA. Doing so will give you access to the GMP documents that they include for members, most of which are must-haves for a dietary supplement business. This will give your company an idea of what processes are needed.
From there, you need to go through and tailor each document to your company. Then, you need to train each person on the one that applies to their job, make a record of that training with the trainer and the person who signs off. Where the gaps come in are on the analytics. Someone must know how to read these and limits should be set for microbes etc. See more sources on Microbes and Certificate of Analysis.
AHPA also offers seminars that are reasonable but sometimes travel is required.
For an online GMP course, note we have not had anyone take these but it is a good place to start. – https://www.pharmalessons.com/free-courses/gmptraining/
This one is a broad brush on how to get started receiving. Inventory control is not included. – https://instituteforfoodsafety.cornell.edu/trainings/good-manufacturing-practices-registration/
We plan to do a short course at champs that will include a small manual and touch on the ones that are the MUST haves for GMP.
Some of them are:
Required Labs, Chain of custody including a Recall Procedure, Packing procedures in a sterile environment, Receiving,
Alkemist Labs (they’re great and supported by AHPA) – https://www.alkemist.com/testing-services/identify/
For those not able to build a clean room we suggest renting a kitchen as a lot of places have these. Here’s an example. If you google “renting kitchen” in whatever city you’re in you’ll be able to find lots of results. This way you are at least food safe.
Remember selling not for human consumption is 100% not GMP.