GMP pharmaceutical manufacturing compliance is crucial in both ensuring the safety, effectiveness, and reliability of a drug, as well as bringing a drug to market. Compliance requires careful attention to multiple aspects of the manufacturing process – something that requires the expertise and experience of professionals.
Good Manufacturing Practices or GMPs have been set to guide the various aspects of production and testing of pharmaceutical products. Throughout the 1900s, there were many incidences of adulterated and mislabeled products, poisonings, injuries, and even deaths, which pushed the U.S. government to enact laws that aimed to minimize risk while simultaneously maximizing the benefits of these drugs.
Today, the FDA inspects GMP pharmaceutical facilities according to specific regulations. In addition, the agency also acts on any valid reports they receive about pharmaceutical products that could pose a threat to patients, and inspects the facilities in question, if necessary.
Should a facility be found to be in violation of any GMP regulation during these inspections, the drug in question would by law be considered “adulterated.” While this many not automatically mean that the drug is defective, unsafe, or ineffective, regulatory actions will be taken against the manufacturer as a preventive measure. However, for drugs that are already being distributed, the FDA can request the company to recall the product.
Apart from these, the FDA can also file a seizure case, which asks for a court order to have the drugs in question seized and destroyed. For more serious cases, the FDA can file criminal cases, which can result in jail time or fines for the company, if convicted.
To ensure GMP pharmaceutical manufacturing compliance, companies will do well to seek the help of experts. By outsourcing to a pharmaceutical contract manufacturer well-versed in GMPs, a company can rely on the expertise of professionals in producing safe and effective drugs.

April 24th, 2012
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