Recently completed projects include...

Pharmaceutical Process Validation:

Performance Validation assisted a major pharmaceutical manufacturer in developing process validation protocols for a parenteral product with multiple product presentations.  PV assisted in protocol generation, facilitated pre and post-execution approval and assisted in non-conformance resolution. A project manager's representative summarized the effort best, "Your prompt attention and dedication to the project was clear from the outset. Just an outstanding, professional job.  I would highly recommend Performance Validation."

Class 3 Medical Device Manufacturer:

Performance Validation as part of a multi-company project team provided consulting services to a US Class 3 Medical Device Manufacturer.  PV assisted the client with the development of a new site Validation Master Plan and improvements in their cleaning validation methods and approaches. 

Non-US Medical Device Manufacturer (PMA support):

Performance Validation as part of a multi-company project team provided consulting services to a Non-US Medical Device Manufacturer.  The product supported for this project is a Class 3 medical device.

Services provided included, consultation with the client and other non-client team members on the following documents:

   - Validation plan

   - PQ of the bulk component

   - PQ of the filling of the bulk component

   - PQ of the syringe assembly

   - Statistical methods employed in determining the number of PQ runs, and sample size selection

Additionally Performance Validation assisted in the preparation and review of responses to FDA questions concerning the PMA submission.  All FDA questions were satisfactorily resolved and the PMA is currently under review.  

Facility Renovation (USP Purified Water System):

Performance Validation provided commissioning and qualification support for a major renovation to a USP Purified Water system for a leading global pharmaceutical manufacturer located in the Midwest.

The scope of the project involved equipment and instrumentation upgrades, the addition of an online monitoring system, and a complete control system replacement.  The project schedule was critical, as the distribution loop was required to be taken completely out of service during this major system upgrade with no backup water system in place.

Our team worked extended hours side by side with the client to support the aggressive schedule.  Additionally PV leveraged their industry and technical knowledge as well as site-specific experience, this team effort ensured that the system was returned to the users ahead of schedule and that the project resulted in a more robust system.    

One operations' representative summarized the effort best, "It's amazing what we can do when we get the right people involved!"

Temperature Mapping:

Project 1:

Performance Validation was approached by a customer to provide temperature mapping support of multiple 2-8 deg C cold boxes for a non-local pharmacy storage/distribution company.

After discussing the cold box layouts and test approach with our customer, PV provided an innovative solution which significantly reduced the project cost.  This cost reduction was accomplished by providing pre-programmed temperature monitoring probes from our equipment inventory to the project site, and having the customer complete a customized checklist prior to starting the test.   

The loggers were returned to PV upon completion of the test, and the temperature data results were downloaded and printed.  A final temperature mapping package (which included a summary of the test results along with the printed temperature data/graph reports) for each cold box was prepared and submitted to the client.   The project was completed on time, on budget, and exceeded the customer's quality expectations.

Project 2:

Performance Validation provided validation support for a Veriteq temperature monitoring system for a new generic pharmaceutical distribution warehouse.

Since Performance Validation uses Veriteq data loggers for temperature mapping, PV had a thorough working knowledge of the data loggers and associated software being utilized and was able to incorporate qualification documentation provided by Veriteq into the overall validation package.  This approach, along with PV's experience with the system, resulted in reduced qualification development and execution time, ultimately reducing cost to the client.  PV also developed supporting computer system validation deliverables in accordance with GAMP guidelines in a timely and efficient manner having previously developed similar documentation for the internal validation of their own data loggers.

Project 3:

Performance Validation was able to double their current Veriteq data logger inventory to meet the client's validation needs. The client had a large quantity of temperature controlled equipment requiring temperature mapping intensive validation on a short timeline.  PV increased equipment inventory from 50 to 100 data loggers and completed internal validation requirements on the data loggers on short notice, enabling more qualifications to be executed at a time for the client.  The flexibility shown by PV in quickly acquiring and putting more data loggers into operation allowed the client to meet their schedule commitments.