Breaking GMP into Simple Steps

In the pharmaceutical and dietary supplement world, it is absolutely required to be GMP compliant.  Many cannabis manufacturers are waking up to the fact that GMP compliance may be the deciding line of who can stay in the game for the long haul.  As regulations evolve, GMP requirements are written into the laws which dictate how cannabis products must be manufactured.  Going for GMP compliance can seem overwhelming, but anything is possible if broken down into small steps.  GMP is built on a few simple pillars, and with enough dedication, any company can achieve a certification.

In order to conform to GMP regulations and have your cannabis production facility obtain GMP certification, you follow these 6 steps. 

1. Maintain cleanliness & hygiene. The manufacturing area will need to be clean and hygienic at all times. This is to provide a fully controlled environment in order to prevent the cross-contamination from other substances that can affect the quality of the product, or even make it unsafe for human consumption.

2. Clearly defined procedures. Manufacturing processes need to be controlled. If there are any suggested changes in the process, then they need to be carefully evaluated. Changes that might affect the quality of the cannabis must be validated first before being implemented.

3. Good documentation practices. Instructions for every step of the process must be fully documented. These need to be written in clear and easily understandable language. Records must document the manufacturing process. They will record the steps that were taken by the pre-defined procedures. These records ultimately confirm that the instructions were clear and followed and that the quality and amount of the cannabis is what is expected. There should also be documentation of any issues in the manufacturing process. These records also trace the full history of each batch. If there is a future issue with one of the batches, its full history can be traced back to the beginning. These records may be done manually or electronically, although electronic documents require a higher level of compliance and validation of the electronic system.

4. Training. Each person involved in the manufacturing facility must be fully trained in their part of manufacturing process. They must also learn how to document procedures.  Each person must be qualified for the job for which they are hired. 

5. Batch recalls. Any cannabis product that is sold to consumers must have a system in place for recall, should there be any issues with it. This system must allow for recalling a particular batch or batches from the sale or supply in order to lessen harm.

6. Established complaint process. If there are complaints about certain cannabis products then they must be swiftly examined. If there are found to be defects in the quality, the batch must be analyzed. Procedures need to be set into place so the problem doesn’t occur again.

It’s not the FDA’s job to ensure that your cannabis manufacturing facility conforms to these regulations, but they’ve developed a successful system of controlling production and ensuring quality. It is your company’s responsibility to ensure that only the most effective and efficient processes are used to manufacture the cannabis pharmaceuticals destined for the consumer market.