GMP Regulations in Nutraceutical Development

Posted by The Garner Group on Mar 10 2017


More and more people are taking steps to get healthy which has increased the use of Nutraceuticals not only in U.S but around the world. To ensure that consumers are getting quality products, the federal government created and reinforces Good Manufacturing (GMP) requirements.

GMP is also referred to as cGMP where the c is for current. This means that manufacturing processes, systems and technologies have to be updated to be in compliance with regulations as they are updated.

GMP guidelines help companies to develop and maintain controls in the manufacturing process. The goal is to ensure that nutraceutical products are processed, manufactured and labeled consistently and as per set quality standards. GMP guidelines are the minimum requirements and regulations for the equipment, facilities, methods and controls for the manufacturing, packaging, and distribution of dietary supplements. The guidelines apply to all companies that manufacture dietary supplements, regardless of size. The FDA is in charge of enforcing the guidelines.

Non-observation of Guidelines

According to Nutraceuticals World, recent FDA GMP inspections indicated that a good number of dietary supplement manufacturers are not fully compliant with GMPs. This was attributed to a lack of specifications for ingredients as well as for finished products.

According to research done by Natural Products INSIDER, 65% of the firms that the FDA inspected in the 2013 fiscal year were not complying with GMP observances. The most common violation was the failure to verify whether a batch of products that were ready for the market was up to the given purity, identity, composition and strength standards. The second most common was the failure to verify a dietary ingredient through at least one test or examination before the product went into the market.

Regulatory Compliance Jobs in GMP

GMP regulatory compliance jobs involve making visits to manufacturing facilities to check processes and equipment to verify that they are compliant. Trained inspectors can also ask to see evidence that the employees in a facility are trained in GMP.

GMP inspections involve:

  • Checking that manufacturing areas are hygienic
  • Verifying that raw materials are of high standards
  • That there are clear, written instructions defining the manufacturing processes
  • Validating any changes made to manufacturing processes
  • Ensuring that employees are fully trained in GMPs and organizing training when guidelines change
  • Checking records to ensure that the correct procedures have been followed
  • Ensuring that batches of products can be traced so that recalls can be done if the need arises to do so
  • Ensuring that any issues that arise are documented and investigated
  • Ensuring that any consumer complaints are recorded and exhaustively investigated

Legal Problems

GMP regulatory compliance jobs also involve reporting companies that are not complying with GMP guidelines, which could be followed by an investigation and products possibly getting recalled or withdrawn from the market if found to be substandard.

As the FDA steps up GMP inspections, GMP regulatory jobs will open up. This will for positions like Validation Officer, Quality Engineer, and QA Manager all of which require GMP training.

Topics: nutraceuticals, compliance

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