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