California Cannabis GMP Requirements
Many California cannabis manufacturers are unclear about whether they need to follow Good Manufacturing Practices (GMP) in their operations. At the federal level, this confusion is understandable given the FDA’s inconsistent and unclear approach to regulating cannabis and its components, including cannabidiol (CBD). California regulations, on the other hand, are quite clear on this subject. The California Department of Public Health (CDPH) adopted final rules for commercial manufacturing, packaging, and labeling of cannabis and cannabis products in January 2019. For anyone who is still unclear about GMP requirements in California, I refer you to DPH-17-010, Subchapter 3, Article 3, which is unambiguously titled, “Good Manufacturing Practices”.
In a nutshell, this section of the CA code requires the implementation of manufacturing controls that are substantially equivalent to the federal cGMP regulations for food, supplements, and drugs promulgated in 21 CFR Part 117, 21 CFR Part 111, and 21 CFR Part 211, respectively. The California requirements for cannabis follow a risk-based approach to preventive controls, similar to 21 CFR Part 117. For example, CDPH §40253 requires that licensees create and implement a written product quality plan for each type of product manufactured at the premises. This is analogous to the requirement for a food safety plan in the Food Safety Modernization Act (21 CFR 117). California requires the product quality plan (PQP) to identify potential risks and the preventive measures that will be implemented to mitigate each risk. The PQP must also describe methods for evaluation and monitoring of the preventive measures, as well as corrective actions to be taken if the mitigation is unsuccessful.
California’s GMP regulations for cannabis also require a written master manufacturing protocol for each unique product formulation and batch size, and the generation of a batch production record (BPR) every time a batch of cannabis product is manufactured. Master manufacturing protocols must include identification of the name and concentration of the product, a complete list of components, the weight or measure of each component, the expected yield of the finished product, and a description of the packaging and labeling of the product. They also must include written instructions for each point, step, or stage in the manufacturing process, including actions taken to mitigate risks established in the PQP.
Batch production records require documentation, at the time of performance, of… well basically everything. The BPR needs to capture component lot numbers and UID numbers, equipment identification, records of equipment maintenance, cleaning and sanitizing, actual weights and yields obtained at various steps in the process, and the results of any monitoring, testing or examinations performed. Records need to indicate the date, time and initials of the person performing each step in the process, such as weighing and adding components, as well as the initials of the person verifying those activities. California regulatigon also requires a documented review of the BPR, the monitoring operations, and the finished batch-testin records by quality control personnel and a disposition decision to approve or reject the batch.
Of course, all manufacturing records are subject to inspection by the Department, its inspectors, and agents. And remember: in GMP audits, if it’s not written down, it didn’t happen.
