These guidelines are in place to be sure that when a company is manufacturing and preparing new goods it is done in the cleanest, neatest way possible, ensuring every utensil and surface used to create the product was up to these certain set of standards. It also certifies that the process from record keeping, all the way to the packaging of that new good, is done correctly and precisely, and every employee involved had the proper credentials to partake in the production.
GMP ensures that the product is exactly what the product claims to be and that it was created by the standard guideline set known as GMP. The "c" in cGMP is in place to certify that every step used in producing this product was done as the guidelines of GMP are stated, but they were finished in a more current manner.
This means that as GMP rules and regulations are constantly improving, and increasing to better the production of new goods, the cleanliness of the process of creation, and neatness are also being improved and updated.
Since cGMP is mostly using new innovative technology the cost is usually more to implement than a regular GMP manufacturer. This is because new technology is expensive. It has to undergo newer, and more in-depth testing and requirements than that of FDA GMP so that the certification is accurate and proven to be effective.
A consumer usually cannot detect through smell, touch, or sight that a drug product is safe or if it will work. While CGMPs require testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of a batch for example, a drug manufacturer may test tablets from a batch that contains 2 million tablets , so that most of the batch can be used for patients rather than destroyed by testing.
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.
FDA inspects pharmaceutical manufacturing facilities worldwide, including facilities that manufacture active ingredients and the finished product. Inspections follow a standard approach and are conducted by highly trained FDA staff.
FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the CGMP regulations. 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. For consumers currently taking medicines from a company that was not following CGMPs, FDA usually advises these consumers not to interrupt their drug therapy, which could have serious implications for their health.
This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
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