The quality of a drug product is of the utmost importance to the consumer and to the brand whose reputation relies on manufacturing safe and effective drug products. The US Food and Drug Administration (FDA) regulates the quality of drug products through current Good Manufacturing Practices (cGMP). This includes the manufacturing of Over-the-Counter drug products.

Fabriquer des produits OTC pour les États-Unis : les cGMP

What are current Good Manufacturing Practices?

Current Good Manufacturing Practices are a system of regulations that ensure proper design, execution, monitoring and control of manufacturing processes and facilities. When a manufacturer adequately controls their processes, they are able to attest to the identity, strength, quality, and purity of their drug products. These regulations are outlined in 21 CFR Part 210 and 211.

The cGMP regulations outline a system that helps ensuring high quality products, and preventing contamination and deviations. This system includes:

  • Establishing a strong quality management system
  • Using high quality raw materials
  • Establishing robust operating procedures
  • Detecting and investigating deviations in product quality
  • Maintaining reliable laboratories for testing

In addition, the “current” in current Good Manufacturing Practices refers to the requirements that companies use up-to-date technologies and systems in their manufacturing process. Equipment and systems that may have been top-of-the-line several years ago, may be inadequate for today’s standards.

Which parts of the manufacturing procedure are regulated by cGMP?

Please note that the following is a general summary of the processes regulated through cGMP. For full details, see CFR Title 21.

The manufacturing of a drug product must be closely controlled in order to ensure a high quality product. 21 CFR Parts 210 and 211 outline, in specific detail, the procedures and process for:

  • Organisation and Personnel
  • Buildings and Facilities
  • Equipment
  • Control of Components and Drug Product Containers and Closures
  • Production and Process Controls
  • Packaging and Labelling Control
  • Holding and Distribution
  • Laboratory Controls
  • Records and Reports
  • Returned and Salvaged Drug Products

When does a product need to adhere to cGMPs?

Any drug product, including Over-the-Counter products, that are produced for the United States must comply with FDA cGMP regulations. Failure to comply with cGMP regulations when manufacturing any drug product results in an “adulterated” product and regulatory action by the FDA.

The FDA has published a “Cosmetic Good Manufacturing Practices” guideline that outlines recommended procedures for manufacturing Cosmetic products. While the FDA’s GMP regulations are not legally enforceable for Cosmetic products, failure to adhere to the FDA’s recommendations could lead to an “adulterated” product.

When a product is considered both a Cosmetic and a drug product, cGMP regulations must be adhered to. To help you establish whether your product fits into this category, do not hesitate to read our article on the matter.

The FDA's role in cGMP compliance

The FDA inspects manufacturing facilities worldwide to ensure cGMP compliance. This includes facilities that manufacture the active ingredient, as well as the finished product. The FDA also uses reports from the public to identify sites that may potentially have manufactured defective drug products.

What if my product does not adhere to cGMPs?

When a company manufactures drug products without complying to cGMP regulations, the manufactured product is considered “adultered.” When the FDA becomes aware of drugs being manufactured in violation of cGMP, they will take regulatory action against the companies involved. The level of regulatory action taken will be specific to the circumstance, and will depend on the impact of the violation. In some cases, regulatory action by the FDA will be intended to stop the manufacturing or distribution of said product. Moreover, the FDA can bring cGMP violations to criminal cases, which could result in fines and jail time.

Want to know more about cosmetic compliance in the United States?

For more information on EcoMundo's services and software for your compliance in North America, do not hesitate to contact our expert, Mr. Michaël Sommeil by phone at : +1 (514) 575-6085 or even send him an email at [email protected]

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