Facts About Current Good Manufacturing Practices (cGMPs)

         Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every one. Consumers expect that each batch of medicines they take will meet quality standards. So that, they will be safe and effective.  
         Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  Recently, FDA has announced a number of regulatory actions taken against drug manufacturers based on the lack of cGMPs.  This paper discusses some facts that may be helpful in understanding how cGMPs establish the foundation for drug product quality.

What are cGMPs?

• cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).  

• It provides systems that assure proper design, monitoring, and control of manufacturing processes and facilities.  

• It assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.  

• It assures that drug products meet their quality standards.

• It allows each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures.  

• It allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement.  
  

Why are cGMPs so important?

• It is important that drugs are manufactured under conditions and practices required by the cGMP regulations to assure the quality, safety and efficacy of drug products.

If a manufacturer is not following cGMPs, are drug products safe for use?

• If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law. This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug.

A new drug company can learn about cGMPs and about FDA’s expectations on complying with them via www.fda.gov which also contains links to the cGMP regulation.