Poor-quality medicines and medical devices are not only a health hazard, but they are also a waste for both individual consumers and the government. Fortunately, GMP comes into play.
Many countries only accept the sale and import of medicines that have been manufactured under GMP guidelines. Most governments seek to promote their countries’ pharmaceutical exportation by making GMP mandatory for all production.
GMP is necessary for the quality control laboratory. After all, good quality is primarily built during the manufacturing process. GMP helps avoid errors that are impossibly be eliminated through the final product’s quality control. Without it, it is impossible to ensure that every medical device or medicine unit is of similar quality as the unit tested in the laboratory.
What is GMP
GMP stands for Good Manufacturing Practice, promulgated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. These regulations require that packagers, processors, manufacturers of blood, some food, medical devices, and drugs take proactive steps to ensure safety, purity, and efficacy in their products.
With GMP regulations, a quality approach to the manufacturing process is required. This enables many companies to reduce and even eliminate cases of errors, mixups, or contamination. In return, consumers are protected against purchasing ineffective or dangerous products. If companies fail to comply with the GMP regulations, they are subjected to serious consequences, such as fines, seizures, recall, and jail time.
Through the GMP regulations, issues like compliant handling, process validation, equipment verification, cleanliness, sanitation, personnel qualifications, and record-keeping are appropriately addressed.
Most of the GMP requirements are open-minded and very general. This enables every manufacturer to decide about the best way to implement critical controls. Besides providing flexibility, the manufacturers must interpret the requirements where the methods make sense for every business.
Importance of GMP
GMPs are an essential system that every manufacturing facility should implement. These regulations help ensure proper design, control, and monitoring of the manufacturing facilities and processes.
Companies should adhere to GMPs to ensure the quality, strength, and identity of each product. Once implemented, these standards help minimize the facility waste and losses. GMPs also help protect the environment, consumers, and companies from harm.
The FDA has set the Current Good Manufacturing Practices (cGMP) that gives manufacturers from different industries a set of standards. These standards help many manufacturing facilities gain and maintain the trust of their consumers who want to know and ensure that the products they buy are safe and well-regulated to the government standards.
Additionally, GMPs in food industry manufacturers are continuously becoming critical nowadays. That is because of the increasing cases of food recalls. Plus, more and more consumers are becoming more aware of food safety. They expect that the companies are taking vital steps to increase their accountability while delivering safe products, and recalls would not happen.
Regardless of the manufacturing facility type, GMP plays a vital role in running the facility. Being a GMP compliant means that the facility makes a strong effort in creating a high-quality, sanitary, and safe environment for a safe and top-notch quality product creation.