Clean Room Sanitization SOP
Clean Room Sanitation SOP
April 13, 2018
John Shilholser and Dr. Huge Hanson Botanical Education Alliance Board Members
Kratom Movement Gains Recovery and Addiction Medicine Experts as a New Board Members
April 27, 2018
Show all

GMP Best Practices Series 1 – How to Avoid Salmonella Contaminations in Your Kratom

GMP Series 1 - How to Avoid Salmonella Contaminations in Your Kratom



The BEA would like to start off by saying: we know that there is a lot of confusion around Kratom and what companies are required to do in terms of compliance.

We are going to keep this updated to Testing Best Practices for Food Ingredients and Dietary supplements, which means this article applies to anyone marketing a product with the intention for consumption or contact with human skin (especially your face).


To quote from the European Journal of Nutrition:


Disclaimer – Minor grammatical and spelling errors have been changed from original


Gone are the days that companies can just simply rely on their raw material suppliers’ certificate of analysis (CoA). Companies have to assume the responsibility for the accuracy of the CoA through testing to verify the accuracy of the data and qualify the data against the company’s own internal specification for all raw material. GMPs require that food ingredient and dietary supplement companies qualify their suppliers if they are going to rely on the data on the CoA.




Unfortunately, dietary ingredients and their CoAs can pass through many hands, especially if brokers of raw materials are used, before making their way to a company’s facility for processing. As a result, this provides plenty of opportunity for contamination and/or fraud to occur. Depending on the nuances of a company’s supply chain, it may not be enough to just compare a CoA against expected specifications. CoAs may not always be a reliable testament to the quality of the ingredient, and proper testing to verify the source may help eliminate this type of adulteration.


Let’s do a quick “audit” of your company’s quality system:


Follow the procedure..


If YES proceed to next question

If NO? You need to be doing this to ensure safety of your product.


  1. You have re-tested all bulk material that arrives at your facility using a frequency testing scale? One box per 1000 kilos is not enough.


  1. You have a receiving process in place that includes quality hold for products that require testing?


  1. You should have a lot sampling and testing process that covers both raw material and product that have been packed or processed at other GMP facilities (the testing for materials that have been processed at another GMP facility generally would be a lot less then for Raw materials). This process includes all testing recommended by an established organization like – AHPA’s Recommended Microbial Limits List


  1. If you pack all of your own product you must have a clean room


  1. You have a Clean Room Sanitation process (SOP).See Clean Room Sanitation SOP example


  1. You have a temperature controlled facility where all product are stored and follow the recommended storage temperature of room temperature or below. You also keep a temperature log. (remember that bacteria grows 10 fold in temperatures above room temperature).


  1. You have batch control in place so you know what product when and where problems occur.If No – Try setting one up using DEAR MANUFACTURING


  1. You have an established Recall process – which if you follow 1-6 you should NOT need to use!


Recent FDA Notice Regarding Kratom and Salmonella


Due to the recent FDA notice regarding the Kratom and Salmonella contamination, we encourage all manufacturers to take precautions by cleaning all work surfaces and ensuring proper Lot Sampling (one box per 1000 kilos is not enough!) It has been recommended one per 100 kilos and using a probe to ensure you can get from the bottom of the box.


If in the case you are a kratom vendor receiving a FDA notice in regards to a concern about your product, the BEA encourages cooperating with the FDA to resolve the situation promptly. These are matters of federal law and are non-negotiable.


While the BEA, is not able to answer any company specific GMP questions that you as a vendor may have there are resources that can actively do that.


For instance, please visit the AHPA website for various SOP templates (for members) to use as examples. They also have helpful resources, webinars and seminars for all things GMP/FDA related as a dietary supplement company on regular basis. It is well worth the membership.


If you are brand new, we suggest watching YouTube videos on GMP such as this webinar or doing a few googles to learn more. YouTube has a few videos such as the one above that can really explain GMP in a digestible manner.


Until next time, this concludes GMP Best Practices Series 1. The BEA will continue this on-going educational series to help kratom vendors with their journey to becoming GMP ready.