The aim of Good Manufacturing Practices (GMP) is to ensure that quality medicines, dietary supplements and medical devices are produced consistently and that the label on any batch is scientifically factual. Dietary supplements are now regulated by the FDA and it has not been an easy process for manufacturers to start to comply with the FDA and GMP regulations surrounding the industry. It has taken significant GMP training to help employees and managers come to understand the impact that the regulations have on them. Most branded companies should now be in compliance although smaller businesses have until the middle of this year. Not only their own manufacturing processes should be assessed however, their contract manufacturers and suppliers also need to be operating within GMP laws.
The GMP regulations for dietary supplements span hundreds of pages however the various aspects can be condensed into 10 summarising points.
1. Standard Operating Procedures (SOPs) – SOPS act as a map for manufacturers to help with GMP compliance as they are details of specific processes that have to be done by employees during the production if dietary supplements.
2. Raw Materials Testing- Manufacturers need to test and audit their raw materials suppliers.
3. Validation- Validation involves extensive testing, observation and analysis of every process to assure the equipment, formulas and procedures measure up to established product standards.
4. Cleaning- Between each batch of supplement is produced a validated cleaning process should be carried out an inspected by the quality assurance team.
5. Equipment Maintenance- Equipment should be qualified and then tested on a regular basis to make sure it is always working properly.
6. Environmental Controls- GMP regulations state that raw materials, equipment, packaging and the finished product are produced and stored in environmentally controlled facilities.
7. Product Testing- Tests must be carried out to discover the use-by date for dietary supplements so that they are safe.
8. Packaging and Labelling Requirements- All dietary supplement labels must follow a specific GMP format.
9. Documentation for Traceability- each and every process in dietary supplement manufacture has to be documented and each batch needs to be traceable through records. This allows a batch to be traced if defects or health issues are raised.
10. Training- GMP training is the most important aspect of GMP compliance and every member of staff should go through annual GMP training.