In July 2010 the FDA & Health Canada used industry GMPs (Good Manufacturing Practices) and model regulations from the pharmaceutical industry to draft their cGMPs (Current Good Manufacturing Practices).
CGMPs raised the bar for the manufacturing of dietary supplements. The cGMPs require that proper controls are in place for dietary supplements to guarantee they are processed in a consistent manner, and meet quality standards.
They apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distribution across the US and Canada.
Complying with cGMPs involves not only the manufacturing company but all of its suppliers who must also be cGMP compliant. FDA (Food and Drug Administration) and Health Canada or CFIA (Canadian Food Inspection Agency) auditors conduct the rigorous inspections, which may take several days to complete.
On-site inspections ensure that companies:
- employ qualified employees and supervisors with GMP certification
- design and construct dietary supplements to prevent them from becoming adulterated during manufacturing, packaging, labelling and holding
- use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use
- establish and use master manufacturing and batch production records
- establish procedures for quality control operations
- hold and distribute dietary supplements and materials used to manufacture dietary supplements under appropriate conditions of temperature, humidity, light and sanitation to ensure the quality of the dietary supplement is not compromised
- quarantine ingredients until they're determined to be safe to utilize in formulas
- keep a written record of each product complaint related to cGMPs
- retain batch records for 1 year beyond the shelf life date
- perform testing of final product or incoming and in process materials
- are able to implement a full recall protocol on any product or ingredient if need be