While medical cannabis products do not require federal regulatory approval by the US Food and Drug Administration (FDA) in states where it is legal, the emerging medical cannabis industry ought to adopt its regulatory guidelines and practices that assure the quality of all marketed US drugs and devices. This is because, at present, no universal regulatory guidelines or requirements exist to ensure medical cannabis quality and safety. Not surprisingly, the quality attributes of medical cannabis vary wildly from state to state and even between different locations within the same city, county or state. Clearly, this is not in the best interests of medical cannabis users.
FDA established mandatory federal quality guidelines to guarantee product safety, identity, strength and purity. According to FDA, product safety means that a product is free of unexpected side effects when it is used properly by a patient. Identity guarantees that a product is exactly what its label and related informational materials say it is. Strength means that a given product consistently delivers the correct dosage and potency over its shelf life from its manufacture to its expiration. Purity indicates that a product is free from physical, biological and chemical contamination. Put simply, these guidelines guarantee consumers that products are safe, effective and meet defined quality attributes.
The agency has developed different sets of regulatory guidelines that ensure product quality during various phases of development, manufacturing and commercialization. The existing guidelines that are relevant to the medical cannabis industry include 1) Current Good Laboratory Practices (CGMP), Current Good Clinical Practices (CGCP) and Current Good Manufacturing Practices (CGMP).
CGLPs are the guidelines that regulatory laboratory activities during preclinical development of products. This includes data collection and documentation, creation of standard operating procedures (SOPs), safety and pharmacology testing in laboratory animals, and sample preparation, handling and storage. Traditionally, CGLP helps guide development and ensure the quality of individual molecules but can be applied to extracts, tinctures and other products derived from cannabis plants.
CGCP was developed to guide the planning, conduct and analysis of human clinical trials that are required before a prescription drug can garner FDA regulatory approval. While CGCP is not relevant for most medical cannabis growers and dispensaries, it is required for companies that are currently trying to develop cannabis-derived pharmaceuticals and related products.
The set of regulatory guidelines that is most appropriate for a majority of medical cannabis growers, formulators and dispensaries is CGMP. CGMPs were developed to assure that:
- Raw materials used in the manufacture of pharmaceutical and biotechnology products are of known and possibly standardized quality and are free from contamination
- A manufacturing process is proven to produce a product that consistently meets its specifications and quality attributes
- Adequate quality control and assurance testing measures have been employed to assure that a product meets its quality specifications at the time of release to market and at the end of its shelf life
There are 10 basic CGMP principles that help t o ensure product quality, safety and efficacy. They are:
- Proper design and construction of facilities
- Validation of facilities, equipment and manufacturing processes (materials testing, cleaning, software etc)
- Proper maintenance of equipment, facilities and utilities
- Creation of SOPs (and adherence to them)
- Documentation of all processes, data collection, record keeping etc
- Employee development, on-going training and certification
- Contamination protection and prevention
- Employee health and hygiene
- Product manufacturing records and reports (that enable product recalls)
- Audits and Inspections
Following these principles will help to create a process that produces a product that is reproducibly consistent, safe and effective.
Because FDA approval is not required for medical cannabis use in states where it is legal, there is no requirement that any CGLP, CGCP or CGMP must be implemented. That said, assuring product consistency, quality, safety and effectiveness will go a long way to help establish medical cannabis brand reputation and reliability.