Manufacturers of dietary supplements have a heavy burden to ensure the safety and efficacy of products they produce. There are strict regulations to adhere to as outlined in the Dietary Supplement and Health Education Act (DSHEA). Is your facility meeting these requirements? Find out now and how to get help becoming certain that your supplements are meeting Current Good Manufacturing Practices (CGMP’s) and FDA regulations.
Is Your Manufacturing Facility Up to Snuff?
Under DSHEA, you have the responsibility to create and maintain a manufacturing facility that protects the ingredients from becoming adulterated. Adulteration can happen during the manufacturing process, the packaging process, and the labeling process. Therefore, it’s crucial to be certain that your facility is set up in a manner to facilitate the safety and efficacy of your products.
Are You Keeping Appropriate Records?
CGMP’s also regulate how a dietary supplement manufacturing facility must keep records. In order to maintain FDA compliance, your facility must:
- Create and utilize master records for batch production and manufacturing
- Create written procedures for quality control
- Maintain written records of each product complaint that is relative to CGMP’s
- Retain all records for products for one year or more past the shelf life of the product. If shelf life is not applicable, two years or more beyond the date of distribution of that product
Records can be challenging to keep, especially ones as detailed as those listed above. It’s best to consult with an experienced FDA lawyer. An FDA lawyer can help you learn record keeping practices that ensure your compliance with the FDA.
Do You Have the Right Employees and Equipment?
DSHEA also regulates a dietary supplement manufacturing facility’s hiring practices and equipment. Under DSHEA, your facility has the responsibility to hire only employees and supervisors who are qualified to be working in the dietary supplement industry. More specifically, these people must be qualified to work with the supplements your individual facility manufactures.
Additionally, DSHEA requires that all utensils and equipment used to manufacture a dietary supplement are designed appropriately and are of a quality that is in accordance with their intended use. This means you may need to purchase specialized equipment depending on what type of dietary supplement your facility manufactures.
At FDAlaw.net, we can help you navigate the challenges that both DSHEA and CGMP’s present to dietary supplement manufacturers. Contact us today for a consultation at 786.871.5680.