The pharmaceutical industry must maintain a high standard for drug quality and purity. Standards ensure safe and effective drugs for consumers. Dive deeper into the industry to discover how drug manufacturers ensure safe products.
Correct Purification Practices in Laboratories
Purification is the process of physically isolating, separating, or removing foreign or contaminating substances from a compound. Manufacturers increase the quality of a compound by eliminating impurities. Purification is critical because drug manufacturers must use high-purity organic compounds for medications. Without purification, drugs could cause adverse side effects or fail to perform as intended.
Typically, purification happens in a laboratory setting. But it’s important to note that purification differs between chemical research fields in the various methodologies for extracting substances. Depending on the manufacturing technique, researchers use specific strategies to purify medicine. For example, filtration and extraction are common methodologies.
Strict Regulatory Requirements
Drug manufacturers ensure safe products by adhering to strict regulatory requirements under Good Manufacturing Practices (GMP). GMP is a certification that identifies facilities that fully comply with all FDA regulations and have the proper systems to produce pharmaceuticals and dietary supplements with quality standards and control.
From drug discovery to distribution, GMP emphasizes consistent high standards for all procedures. Patients and medical professionals expect high levels of precision and consistency with all medications. After all, no one wants medicine that’s effective half of the time.
It is a manufacturer’s responsibility to ensure quality pharmaceutical products comply with authorization requirements. All personnel, materials, and equipment must follow correct practices to maintain a safe laboratory.
FDA Reviewal Process
Medicine’s path from a lab to consumers’ cabinets is long and unique. Often, manufacturers develop drugs to treat a specific disease. When manufacturers deem drugs suitable for consumers, the Food and Drug Administration (FDA) evaluates the medication.
The FDA protects public health by assuring the safety, efficacy, and security of human and veterinary drugs. But the approval process is long. To ensure medications are safe, the review process involves several steps. Some steps include preclinical testing, 3-phase studies including 20 to 30,000 people, and facility inspections. The entire process can take years to complete. However, the result is a safe and effective drug.