SOP Critical Issues

The Issues

 The Natural Products Association (NPA) says the pressure is on:

"Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study released last week [April 2013]  by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers.  A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.'..."

Further from NPA:

"FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “'the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.'..."

Says one FDA Compliance Officer:

“Your company, as label-owner, must be in a state of control with its training, labels, claims, manufacturer, shipping & customer service…”

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Says FDA - "...each person engaged in an activity covered by these CGMP regulations must have the education, training, or experience to perform the person's assigned functions. Some employees will be considered qualified based in part on training taken as company employees. To show that such training is appropriate to the employee's functions and has in fact occurred, the training must be properly documented. This documentation is an important aspect of ensuring adequate training and, therefore, helping to ensure the result of having qualified employees who perform their functions properly." Federal register, page 34811.

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"The FDA showed up unannounced. Said they’d be here for at least six days. We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A. C. Company CEO

Some Areas Where FDA Has Expressed Concerns
  
 Product master record 
 Compliant procedures
 Written Adverse Event Reporting procedures
 CAPA procedures and documentation
 Process validation
 Supplier/Manufacturer controls
 Control of non-conforming/returned product
 Quality audit procedures
 Design change procedures
 SOP training and modification

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