Outsourcing?

Survey responses in the Dec 19, 2019 Aspen Alert identified that 83% of the survey respondents would utilize 3rd party resources to support their facilities in the upcoming year:

 

 

 

 

 

 

 

 

Performance Validation’s core business is providing commissioning, qualification and validation services to the pharmaceutical, biotech, and medical device industries.… more


Importation of Drugs

Notice of proposed rulemaking (NPRM) issued Dec 18, that if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.… more


Seasons Greetings from Performance Validation

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Performance Validation Receives Rose-Hulman Recruiting Award

We are honored to announce Performance Validation is in the top ten percent of all recruiting companies in attracting and recruiting Rose-Hulman talent! As a top hiring company during the 2018-2019 academic year, PV played a vital role in providing internship and full-time offers to students from Rose-Hulman.… more


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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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


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


IATA Mapping of Airline Cargo Facilities

IATA Mapping of Airline Cargo Facilities

The Challenge

A large international airline company needed to have temperature controlled storage at two major U.S. airports for the transport and short-term storage of Time and Temperature Sensitive Products (TTSPs).  As part of IATA’s (International Air Transport Association’s) certification process, a temperature mapping is required of all temperature controlled storage areas to be used for this purpose. … 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