Steve Mister of CRN: We Need "Better Enforcement of the Law, Not a Rewrite of It"
Steve Mister, President and CEO of the Council for Responsible Nutrition, authored an op-ed article for USA Today where he argues that the current laws regulating dietary supplements are effective, but need better enforcement. According to Mr. Mister, the dietary supplement industry supports full implementation of the laws as a way to weed out the few unethical practices and companies from an otherwise legitimate industry. The article is part of Mr. Mister's efforts to promote the passage of the Dietary Supplement Full Implementation and Enforcement Act and CRN's efforts to promote compliance and ethical practices in the industry.
Preparing Your Company For Good Manufacturing Practice (GMP) Inspections
The dietary supplement industry has faced uncertainty over how FDA Inspectors will enforce the new Good Manufacturing Practice (GMP) regulations (21 C.F.R. 111). GMP inspections began last year, and dietary supplement manufacturers can now look to inspection observations reports filed by FDA inspectors to prepare their companies in advance of GMP inspections.
Although the GMP regulations currently apply only to companies with more than 20 employees, the rules are set to expand to include smaller manufacturers soon. Steve Meyers, of NaturalProductsInsider.com recently prepared a good summary of FDA inspection observation reports filed within the past year. Here are the higlights:
- Procedures: Inspectors carefully analyze a company’s procedures to ensure that procedures are written, complete, and cover every element of the manufacturing process.
- Implementation of Procedures: Inspectors focus on how effectively each aspect of the company’s written procedures are being implemented.
- Cleanliness: Inspectors focus heavily on cleanliness of the facility, how materials are transported and stored, sanitation procedures, etc.
- Testing: Inspectors focus how effectively the company tests each phase of the manufacturing process, from identifying the quality of the raw materials to verifying the strength of the seal on the packaging.
- Design of Facility: Inspectors even focus on the overall design of the facility, including wither the design ensures proper sanitation, quality control procedures, etc.
