by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …
Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require life science companies to have controls on computer systems that are used to manage CGxP electronic data and records. As part of the implementation and maintenance …
Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit drawings. In addition, we offer assistance with facility location selection. Kymanox have produced the conceptual designs for a wide range of GMP manufacturing buildings: Pharmaceutical …
The purpose of an investigation is to determine why an unexpected event occurred and to prevent it from happening again. We call the reasons for the unexpected event the “root causes,” or underlying causes. Once we understand the root causes, we can identify and implement corrective and preventive actions to …
The Federal Food, Drug, and Cosmetic Act (FDCA), signed into law in 1938, gives the FDA the authority to regulate the sale of food, drugs, and cosmetics. The regulations that guide the enforcement of the FDCA are given in Title 21 of the Code of Federal Regulation (21 CFR). In …
