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 …
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 …
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 …
COMMISSIONING: An Opportunity to Test, Challenge, and Improve the System Prior to Qualification
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 …
PAI Preparation and Remediation
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.
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 …
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 …
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 …
Good Manufacturing Practices (GMP)
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, …
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 …
Facility, Utility, and Equipment Qualification
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 …
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 …
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