Nothing is more significant to the advancement of human health than the use of safe, efficient, and innovative medicinal products. In the pharmaceutical industry, the production of these products requires adhering to current Good Manufacturing Practices (cGMP).
What are current Good Manufacturing Practices? Uncover critical information about these regulations by the U.S. Federal Drug Administration for guiding quality processes in the research, development, and production of pharmaceuticals.
Current Good Manufacturing Practices Defined
What are current Good Manufacturing Practices? Essentially, cGMP refers to the most current version of Good Manufacturing Practice regulations required by the Federal Food, Drug, and Cosmetic Act. These regulations are the foundation of pharmaceutical quality, ensuring that medicinal products are safe, pure, and effective for human use. Professionals in the pharmaceutical industry must be knowledgeable about the latest regulations as GMP standards invariably improve over time.
Why Does cGMP Matter?
The goal of cGMP is to comprehensively enhance product quality through specific design, maintenance, and monitoring processes in facilities. Quality matters, meaning these regulatory standards carry tremendous weight in quality control and assurance. Developers, manufacturers, and packagers of these drug products must ensure that the identity, quality, purity, and strength are of the highest possible standard.
cGMP is of great importance for those taking OTC drugs, biopharmaceuticals, or prescribed drugs by healthcare providers. Through these meticulous regulations, the FDA can verify that a pharmaceutical is well-tested, labeled correctly, viable for use, safe for human consumption, of the right strength, and not contaminated.
Ensuring Compliance With cGMP Regulations
How do cGMP regulations apply in facilities or laboratories? To comply with these practices, companies must implement and maintain quality management systems, reliably use good quality raw materials, set up straightforward operating processes, and regularly test for any deviations from standard quality. Professional organizations must utilize well-maintained facilities and equipment, employ those properly qualified and trained, and sustain cGMP processes that produce reliable and reproducible results.
Those cGMP-certified have additional credibility to assure their facilities are scientifically sound and quality operating procedures are up to date. Moravek is an experienced contract manufacturing company offering solutions for medical research and clinical trials worldwide. Learn more about our cGMP Quality System, dedicated QC lab, and custom API pharmaceutical manufacturing services on our website.