GMP Quality Assurance and Control: The Difference and Importance

Good Manufacturing Practice — GMP — is essential for ensuring that pharmaceutical products are produced according to the standards put in place by the FDA. These GMP standards are designed to help minimize the risk of contamination and harm to consumers. Today, technology has only helped to further improve these standards, with cleanrooms now able to maintain humidity at as close as a plus or minus 1% tolerance. Improvements such as these help ensure products aren’t compromised, both during testing and during storage.

GMP quality assurance encompasses everything from production and facilities, to equipment and personnel training. It is also essential that GMP quality assurance measures are well documented throughout each and every step to ensure that procedures are being followed correctly and that nothing crucial was overlooked that could compromise the integrity of a product.

GMP Quality Assurance and GMP Quality Control

  • Quality Assurance: is a facet of Good Manufacturing Practice that encompasses all aspects that impact the overall quality of a product. GMP quality assurance is essential for making sure a final product has the quality expected of it and the quality that is required for it to work as intended.
  • Quality Control: this part of Good Manufacturing Practice deals specifically with sampling, testing, and documentation. GMP quality control is used to ensure that all preliminary testing is carried out and that the quality of the final product has been deemed to meet all standards.

FDA Compliance

The FDA ensures that GMP standards are being met at facilities across the globe. This includes any and all facilities involved in the manufacturing of any included ingredients, as well as those involved with the final product. This means that storage facilities must also meet specific GMP storage conditions to ensure that a product isn’t compromised by temperature or cross-contamination. While FDA inspections are crucial, they also rely on reports from the industries themselves and from the public. The FDA uses this information to determine which facilities need to be investigated. Most facilities inspected by the FDA are found to be in compliance; however, frequent inspectings are still necessary to ensure nothing is overlooked or missed.

A Failure of Compliance

If a facility is found to not be complying with GMP quality assurance, control, or storage standards, the products made there are considered “adulterated”. This means that the product in question isn’t meeting standards, though it does not mean that it is necessarily compromised.

For instance, if someone is currently taking a product that is found to be “adulterated”, the FDA will typically advise that consumers not stop taking it without first consulting their physician, as suddenly stopping could have adverse health effects.

The overall impact of action taken by the FDA in the case of non-compliance will depend on the violations. Only rarely will FDA action result in stopped production or distribution. The exact circumstances will be specific to each instance with health care providers being the best to determine if a product is best for a patient.

Staying Up To Date

The Federal Register, published by the FDA, is the best source for the public to learn about the current standards and any changes that are being made. The FDA’s Website also houses links to current documents so that you can always stay up to date with all GMP standards.