It’s important to stay on top of GDP–Good Documentation Practices–so that your cannabis business can comply to FDA and other government regulations. Good documentation practices are an important tool that can be used in your company’s compliance with the FDA and other government agencies responsible for the current or future licensing of cannabis products, state-wide or federally.
Because certain products are destined for human consumption, they must be safe and not cause harm. In order to meet certain quality controls, documentation is necessary through every step of the process. This better enables the company to look back through the records to answer questions. It will also provide a guideline for the future manufacturing of products so that the quality is the same. It will also allow the FDA and governmental authorities to go through the records to see if compliance is 100%.
In order to gain a good understanding of what’s expected of your organization, there are some steps that you must follow.
Documentation is understood as being mandatory and not optional in a quality assurance system. Having a good operations manual with written procedures will prevent any errors from misspoken communications. It also provides a record that can be referred to at a later date.
If there are forms required, they must be prepared and designed in advance, reviewed by management, and distributed when required. These documents may need to be approved or signed and dated by the worker or an authorized person after they’ve been completed.
Documents should be clear, well-organized, and be easy to check. If they are reproduced, copies should be clear and legible.
These documents must be regularly reviewed and filed. If there are new versions, due care must be taken to prevent the old ones from being used.
Documents and forms should be typewritten. If they are being filled out, handwriting should be legible. A pen must be used, rather than a pencil.
If there was an error made on the form, then it should be crossed out, and then corrected, and initialed by the person making the change. This is so questions can be directed to the person who made the change.
Any activity related to the manufacturing of your cannabis products should be recorded. This may include preclinical studies, clinical trials, etc.
All documentation needs to be stored in a secure place and locked up. There should be limited access by only authorized persons. This location should be secure from fire or floods.
If there are specific records that must need to be kept for compliance to FDA or other government organizations, this type of documentation needs to be backed up and kept off-site.
There should also be procedures in place to ensure that data is adequately stored and backed up on a regular basis.
There are many more steps that may be needed for your cannabis business to achieve compliance. Please contact Compliance Naturally if you’re interested in learning more.