Impact of FDA GMP Guidelines

In 2008, the first stage of FDA GMP guidelines inspection was targeted at companies with 500 or more employees. While the FDA appeared generally satisfied with the fifteen large-sized companies that were audited, the real test of the industry will be when the more than 200 mid-sized companies will be put under the strict scrutiny of an FDA audit for GMP certification.

NBTY was one of the first few companies to be audited under the new FDA GMP guidelines. The audit resulted in a 483-page letter to NBTY with a 28-page inspection report consisting of minor non-compliance discrepancies. NBTY, however, was able to quickly comply with all non-compliant issues and achieve FDA GMP status.

The questions are:

  • If the big-sized companies in the dietary supplement industry, considered well-equipped to be FDA-GMP ready, did not pass the audit in full flying colors, how will the middle-sized companies fare this year?
  • Is your mid-sized supplement manufacturer GMP ready for the inevitable audit? Has it taken the remedial steps necessary for full compliance?

The first question to ask is: Is your mid-sized contract manufacturer already GMP certified? This would naturally mean fewer compliance issues in order to become FDA GMP ready.

What Sets a GMP Certified Company Apart from a Non-GMP Certified Company?

  1. GMP certified manufacturers have already shown their readiness to comply with quality controls in order to ensure a more superior end product. Because many of the QC and QA measures are already in place, GMP manufacturers are in a position to more easily comply with the new FDA-GMP guidelines
  2. Commitment to quality. According to the specifications of the new GMPs, it’s no longer enough to have a quality product that meets label specifications. Quality procedures throughout the production process are essential. All QA and QC measures should be aligned to FDA GMP standards and be supported by a written paper trail.
  3. In-House Lab Facility. Testing of quality right from the arrival of raw materials to the end product is easily possible with a fully-equipped lab facility. Besides, a contract manufacturer with an R & D department can assist you in the formulation of your product. Such manufacturers are in a position to offer you quick technical advice as well through the use of precision equipment and scientific research professionals.
  4. Proven Track Record. A contract manufacturer who has been in the business for more than a decade has much more in-depth knowledge of the nutraceutical industry than one who is still a rookie. In terms of trends, scientific research, as well as consumer expectations, a seasoned GMP manufacturer will prove to be an invaluable asset through the good times, and ride with you through rough weather.
  5. Experienced GMP contract manufacturers will also have knowledge of regulatory issues and be in a position to properly advise clients with legal and regulatory updates and how it could impact production, sales, or even labeling practices.

While June 25, 2009 was the deadline for compliance with new FDA GMP guidelines for mid-sized dietary supplement manufacturers having 20 to 499 employees, the inspection of mid-sized companies began in late 2008. The FDA hopes to inspect at least 200 companies in 2009, beginning in Utah and California where most mid-sized dietary supplement manufacturers are based.

The sweeping audit can last for days or even weeks. A general gist includes:

  • Physical inspection of the full facility, controls for hygiene and non-mingling of raw materials
  • Written policies on procedures, SOPs, training manuals, basically all auditable paper trail that leads to standardization of quality controls must be current and in operating existence.
  • Equipment maintenance logs and calibration records.

What the Latest Round of GMPs Means to You and Your Business

Undoubtedly, the impact of GMPs on the contract manufacturing industry will result in a more unified quality standard. In the long run, it will help to uplift the image of the dietary supplement industry as a whole and take it to a more respectable level. Not only will it bring about more consumer trust in supplements, but this trust will translate into increased revenues for those who are still standing after the FDA inspection. Using a GMP certified supplement manufacturer can safeguard your business and interests allowing you to be a long term, key player in the future dietary supplement industry!

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