What is cGMP and Why Does It Matter
CGMP is an acronym for Current Good Manufacturing Practice regulations that are enforced by entities such as the Food and Drug Administration (FDA) in the United States or the Food and Drugs Act for Health Canada.
The purpose of such regulations is to ensure that medicinal products are manufactured to a certain standard to ensure consistent quality, safety, and efficacy. The regulations apply to a variety of procedures including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, as well as complaint handling, and the governing authorities conduct regular inspections.
Why Is CGMP Important?
To ensure a medical product is safe for consumers, it must undergo testing. Because a product is destroyed during the testing process, only a small amount of each batch is tested so that the majority of the medical product can get to the patients in need. For this reason, procedures and quality controls need to be in place to ensure that every medical product, in every batch will meet expectations. CGMP regulations lay out conditions that must be met in order to achieve consistency across all batches.
Many people will recognize the phrase ‘GMP,’ but the occasionally overlooked ‘c’ for current is critical. Manufacturers must stay up to date on all current regulations. If manufacturers are not in compliance, the product they produce will be considered legally ‘adulterated’ and, while not necessarily unsafe, it is non-compliant.
Can A Product Be Recalled If It Is Not CGMP?
Yes, especially if it is ineffective due to a lack of active ingredient or has been contaminated in some way. Regulating bodies like the FDA do not have the authority to recall medicines, but they can request that a company do so voluntarily. If the company refuses, the FDA can release a warning to the public and seize the offending product.
Current regulations can be found online and are easily accessible to companies needing to stay up to date. Issues are typically caught before products go to market, but regulatory bodies also rely on the public for information when drug products are defective.