BI Insight: Manufacturing Practice for Pharmaceuticals
Pharmaceutical drug products deliver over 446 billion dollars of revenue annually in the United States. The FDA is tasked with protecting the public by minimizing the risks to consumers and ensuring that all medications are safe.. Drug manufacturers are required to apply and implement the regulatory and quality standards of CFR Title 21 CFR Part 210 and Part 211. Pharmaceutical organizations must focus on many areas including the following: management of manufacturing plant(s), engineering controls, equipment, aseptic techniques, productions, labeling, storage, shipments, laboratory controls, quality control and quality assurance.
Biomed Innova is set up to work with pharmaceutical companies specifically in quality control testing and in-process and final product release testing. As a cGMP and FDA registered laboratory, Biomed Innova treats quality as its most important objective.