It’s October, the leaves are turning brown, Football season has started, Pumpkin Spice is everywhere, and before you know it, Winter will be here. Have you scheduled your Winter mapping Yet? Don’t miss out, Performance Validation is currently accepting bookings to schedule Winter Temperature Mapping.… more
PV Experience with the Kaye Advanced Validator System (Kaye AVS)
Performance Validation (PV) has had a validated Amphenol Kaye AVS system in our temperature mapping equipment inventory for about a year and has used it to complete several mapping projects by different Kaye users.… more
Performance Validation (PV) will be exhibiting in Booth 348 at the RAPS Regulatory Convergence 21-24 September 2019 in Philadelphia.
The Building Commissioning Annual Conference is a premiere event chock full of training, memorable speakers and presentations, and a chance to connect with prominent building industry professionals!
In the September 4th edition of Device Daily, it was reported that the FDA cited Dharma Research, for failing to validate the storage conditions for its Etchant gel.
Don’t let this happen to you.
Performance Validation (PV) has completed hundreds of mappings including Sub-freezers/cryogenic storage, USP Freezers, USP cold storage or chill rooms, and distribution warehouses. … more
A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing. They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. … more
In a review of the latest one hundred (100) FDA Warning Letters issued as of May 17, 2019, nineteen (19) included the section header “CGMP Consultants Recommended” within the content of the letter, followed by these statements:
PV’s Kevin Marcial will be presenting “A Practical Guide to Risk Based Computer System Validation” at the Midwest Society of Quality Assurance Annual Meeting August 6-7, 2019. Come to Indianapolis to learn about risk-based CSV and other great topics in the QA world.… more
July 10 FDA Warning Letter Review
This past week two warning letters to 503B outsourcing facilities were posted to the FDA website.
In one of the warning letters, the outsourcing facility compounded drugs using raw material not on the 503B bulks list, failed to include all drugs compounded in the prior 6-months, and failed to report an adverse event within the required time period.… more
A common observation during FDA inspections is a failure of the drug company to perform incoming testing of raw materials and relying solely upon the suppliers CofA. A common misconception is that I can simply accept the CofA from my supplier with no testing or qualification of the supplier.… more