Pharmaceutical quality affects the health of every American. Consumers expect that the pharmaceuticals they take meet quality standards, so that they will be safe and effective; however, most people are not aware of how the Food and Drug Administration (FDA) assures that drug manufacturing processes meet these objectives. The FDA regulates the quality of pharmaceuticals through the Current Good Manufacturing Practice (CGMPs). Recently, the FDA announced a number of regulatory actions taken against drug manufacturers based on the lack of CGMPs.
WHAT ARE CGMPs?
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products. Manufacturers of medications are required to establish strong quality management systems, obtain appropriate quality raw materials, establish robust operating procedures, detect and investigate product quality deviations, and maintain reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This
WHY ARE CGMPs SO IMPORTANT?
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the 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. If the failure to meet CGMPs results in the distribution of a drug that does not offer the benefit as labeled because, for example, it has too little active ingredient, the company may subsequently recall that product. This protects the public from further harm by removing these drugs from the market. While FDA cannot force a company to recall a drug, companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and can seize the drug. The FDA advises consumers to seek advice from their health care professionals before stopping or changing medications. Regulatory actions against companies with poor CGMPs are often intended to prevent the possibility of unsafe and/or ineffective drugs.
WHAT CAN THE FDA DO TO PROTECT THE PUBLIC WHEN THERE ARE CGMP VIOLATIONS?
FDA publishes regulations and guidance documents for industry in the Federal Register. This is how the federal government notifies the public of what we are doing and why. FDA’s website, www.fda.gov also contains links to the CGMP regulations, guidance documents, and various resources to help drug companies comply with the law. FDA also conducts extensive public outreach through presentations at national and international meetings and conferences, to discuss and explain the CGMP requirements and the latest policy documents.
If a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law. Regulatory actions against companies with poor CGMPs are often intended to prevent the possibility of unsafe and/or ineffective drugs.