Current Good Manufacturing Practice Certification
CGMP is a variant on GMP that closely aligns with standard FDA requirements in most industries. CGMP regulations contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packaging of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. In every way cGMP is aligned with GMP, other than the ‘c’ or ‘Current’ qualifier.
The Current qualifier on the GMP certification is key in a dynamic and rapidly evolving industry like cannabis.
CGMP requirements were established to be flexible in order to allow each manufacturer to decide how to best implement GMP processes that evolve to their production systems. The system provides for flexibility permitting companies to use new technologies and approaches to achieve higher quality through continual improvement. Companies that obtain the CGMP certification are actually required to use the most up-to-date technologies and systems possible.
CGMP regulations are enforced by the FDA. These regulations provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Just like GMP, adherence to CGMP regulations ensures that manufacturers of medications observe strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect and investigate product quality deviations, and maintain reliable testing laboratories. Having internal testing laboratories is not sufficient as outside validation is always preferred.
Seeking a CGMP certification is not a trivial process, and good guidance through implementing a system is key. In an industry such as cannabis, the input materials, or raw cannabis flower needs to be considered. Where will you obtain it, and to what standard was it grown? Was it dried to a GMP or GACP standard? All these are factors in the process, and once your system is established you can’t just substitute an alternative source, or else your whole certification is at risk.
The Risk of not being CGMP Certified
Per the FDA, if a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law. This doesn’t mean that there’s necessarily anything wrong with the product, but when the FDA encounters an issue, there are serious personal legal implications to anyone responsible.
Compliance is absolutely a wise choice. Some risks just aren’t worth taking when a clear roadmap to compliance is documented and obtainable.
- Cannabis Industry Certifications
- Good Agricultural Collection Practice – GACP
Other certifications that would be helpful, and whose processes definitely should be considered are:
- Global Certifications of relevance:
- ISO Certifications: ISO-9001; ISO-13485; ISO-14001;