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 …
by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …
Commissioning gives biopharmaceutical companies the opportunity to work out the kinks in their equipment prior to qualification for GMP activities. However, companies make the mistake of skipping the commissioning phase. After vendor startup of equipment or after a minimum of air test and balance and room walkthroughs for a facility, …
PAI is the CMC capstone for your product commercialization effort. Kymanox has a perfect track record leading successful PAIs and offers 360-degree coverage for subject matter disciplines.
Manufacturing and process automation significantly improves quality, productivity, costs, and flexibility in the life sciences industry. The continued implementation of automation is being driven by the need for greater consistency, reliability, and efficiency in an increasingly dynamic environment. If quality and efficiency issues are impacting your facility or you would …
High-precision equipment comes with a high price. Validation requires the ability to accurately record data, and it is not always cost or time efficient to purchase your own validation equipment. Whether you have an internal validation team or need assistance from a trained staff, Kymanox can support your project. Kymanox …
Investing in equipment should never have to be a risk. Testing equipment and reviewing documentation for traceability purposes does a great deal towards lowering the risk of your investment. Accepting the equipment only after completing a Factory Acceptance Test (FAT) is industry standard, but the process can be overwhelming. A …
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 …
Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to …
When starting up a new manufacturing area, the qualification of systems that support the drug production process (facilities, utilities, and equipment) is essential to ensure patient safety and product quality, and to meet regulatory requirements and business needs. Qualification must be done quickly and correctly so the area can be …
The Golden Rule: If it wasn’t documented, it didn’t happen! Good Documentation Practices (GDPs) are requirements for documenting and managing information in a Current Good Manufacturing Practice (CGMP) environment. Every employee, contractor, or guest who documents their activities on CGMP documentation must apply GDP. The FDA (Food and Drug Administration), …
