Manufacturing Practice

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 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.

Dannon’s Costly Yogurt Claims

If you haven’t seen Jamie Lee Curtis in the commercials, you have seen the products in the yogurt section at the grocery store. “It Works Or Your Money Back!” is the guarantee that Dannon makes regarding the ability of Activia, its probiotic line of dairy products, to boost digestive system health and immunity. Now an Ohio judge has signed a settlement agreement (pdf) in which the company agreed to pay up to $45 million as part of a class action settlement.