See you at the 2019 RAPS Convergence!

Performance Validation (PV) will be exhibiting in Booth 348 at the RAPS Regulatory Convergence 21-24 September 2019 in Philadelphia.

Sally Zimmerman and Monte McMartin will be representing Performance Validation and are looking forward to discussing medical device validation and system compliance with you.… more


PV & the Building Commissioning Annual Conference

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!

Neil Enlow

Join Certified Commissioning Professional Neil Enlow at the BCxA Annual Conference in Schaumburg, IL from September 25-27.… more


Validation of Storage Conditions

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


Sage Enterprise Management Validation

The Challenge

A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage Enterprise Management (EM) platform in order to improve their efficiencies in accounting, distribution, and manufacturing.  They would be implementing the Sage Enterprise Management (EM) platform as a SaaS (Software as a Service) with a browser-based interface. … more


CGMP Consultants Recommended in FDA Warning Letters

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:

 “Based upon the nature of the violations we identified at your firm, we strongly recommend engaging consultants qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.” and “Your use of consultants does not relieve your firm’s obligation to comply with CGMP.more


PV @ Midwest Society of Quality Assurance Annual Meeting – 6-7 August 2019

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

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


Supplier CofA’s – Do I need to do anything??

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


Compounding Pharmacy Recalls

Recent Compounding Pharmacy Recalls –

Premier Pharmacy Labs is voluntarily recalling all unexpired products, intended to be sterile, due to a lack of sterility assurance. The Unexpired Sterile Drug Product Lots (include dates dispensed) are being recalled due to concerns presented during the latest FDA inspection including insufficient environmental controls, potential cross contamination and lack of product specific process validations. … more


Kaye Validator AVS ICAL Software Validation

The Challenges

A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return the units to service.  more