Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility

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 …

Points to Consider When Validating Computer Systems for CGMP Processes

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 …

Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

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 …

GAMP 5 – URS/FRS

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 …

Validation Equipment Rental

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 …

FAT / SAT Support

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 …

Process Validation

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 …

Good Documentation Practices

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), …