Why do we have drug shortages?

In a recent post by FDA, Janet Woodcock – the primary reason for drug shortages are because of either manufacturing or quality related issues.

All drug manufacturers that sell their medications in the United States must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) requirements.

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PV @ MichBio Event Novemeber 12, 2019

Performance Validation (PV) will be exhibiting at the Cutting Edge/Drug Discovery & Development symposium presented by MichBio on 12 November 2019 in Ann Arbor, MI.

John Underwood and Nicholas Fava will be representing Performance Validation and are looking forward to discussing validation and system compliance with you.… more


Have you Scheduled your Winter Mapping Yet?

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


Kaye Advanced Validator System

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


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