GMP Manufacturing Standards by Product Type
What are the GMP requirements for pharmaceuticals, medicinal cannabis, cosmetics, dietary supplements, and food and beverage products?
By Michael Woudenberg, Vice President, Chemistry, Manufacturing & Controls,
and Karen Long, Senior Director, Drug Development
What is GMP?
GMP, short for Good Manufacturing Practices, are guidelines to ensure products are made in compliance with specified quality / regulatory standards for their intended use. The types of products that may be required to be made under different types of GMP include:
- Pharmaceutical products
- Cannabis products
- Dietary supplements and food additives
- Food and beverages
GMP guidelines include standards on product quality, manufacturing facilities, processes, documentation, training, procedures, distribution and marketing. Different grades/types of GMP standards vary by country/region and type of product, but there are many universal principles.
Snapshot of GMP requirements by product type
GMP Requirements by Product Type
The table below is based on the GMP guidelines in the United States, acknowledging that medicinal cannabis in the U.S. is regulated at the state level.
Pharmaceutical Quality GMP
Pharmaceutical quality GMP is recognized as the highest, most stringent level of the GMP standards and includes extensive standards on product quality, manufacturing facilities, processes, documentation, training, procedures, distribution, packaging and labelling.
GMP regulations of pharmaceutical products ensure patients receive consistently safe and effective medicines meeting their approved specifications. Pharmaceutical-grade products are proven to be safe and effective through a rigorous clinical trial and regulatory process before they become available to consumers. Additional requirements include testing samples of the finished product before each batch is released and retention of reserve and ongoing stability samples.
Under pharmaceutical GMP, drug products are made with quality raw materials and the active ingredient is typically 98% or higher in purity. Ongoing monitoring of the manufacturing process, product quality (including purity and impurity levels), packaging, and stability, as well as routine regulatory inspections are required.
Medicinal grade cannabis
Pharmaceutical and medicinal grades sound like they are the same, but the requirements are quite different. And since medicinal cannabis is regulated at the state level, rather than federally, their requirements vary widely.
Medicinal cannabis can be sold at dispensaries, but cannot make health claims because they are not supported by approved clinical trials to demonstrate safety and efficacy. The requirements for strength and purity vary among states; in some jurisdictions there are no standards for minimum potency or maximum impurities such as pesticides, heavy metals or microbial contamination. However, some states require validated methods of production, and testing, and documents for the production and packaging for medicinal grade cannabis.
Cosmetics are defined as products for cleansing, beautifying, promoting attractiveness, or altering the appearance, but they are prohibited from making any health claims such as affecting the structure or function of the body.
GMP for cosmetic ingredients includes manufacturing standards similar to those of foods. Cosmetic GMP focuses on sanitation and production controls, specifically manufacturing, equipment, training and hygiene. Additional safety testing, such as testing the product on the skin, is required before cosmetic ingredients are allowed to be used.
Dietary supplement/food additive grade
Dietary supplement/food additive grade ingredients are usually found in consumer health products. Unlike pharmaceutical quality products, dietary supplements are not required to complete human clinical trials for safety and efficacy, and cannot make claims to treat or cure illnesses. An abbreviated validation process is common for dietary supplements before they are made available to consumers. They are considered safe until they are proven unsafe.
Dietary supplement GMPs cover personnel, equipment, production controls, testing, packaging, labelling, documentation and distribution.
Food quality GMP
Food quality GMP are minimum standards required to ensure food safety. Food quality GMP elements emphasize sanitation and training and include preventive controls to reduce the risk of food safety issues. Food quality includes guidelines on a food business’ facility, equipment, training, hygiene, pest control and distribution.
- FDA Current Good Manufacturing Practices (CGMP) Regulations: https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
- FDA Guidances and Manuals on Pharmaceutical Quality: https://www.fda.gov/drugs/pharmaceutical-quality-resources/guidances-and-manuals-pharmaceutical-quality
- FDA Food Safety Modernization Act (FSMA): https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
- FDA Food Code: https://www.fda.gov/food/retail-food-protection/fda-food-code
- FDA Dietary Supplement GMP Requirements: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=afbc29dec95942418f63bc6d27f5a895&mc=true&n=pt21.2.111&r=PART&ty=HTML#se21.2.111_1120
- FDA Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics: https://www.fda.gov/cosmetics/cosmetics-guidance-documents/good-manufacturing-practice-gmp-guidelinesinspection-checklist-cosmetics
- NCSL Cannabis and Employment Laws: https://www.ncsl.org/research/labor-and-employment/cannabis-employment-laws.aspx
- Map of Marijuana Legality by State: https://disa.com/map-of-marijuana-legality-by-state