Periodic Review within a Clinical Trial – Manufacturer Organization

The Challenge

A clinical trials materials manufacturer requested assistance in completing their 2012 direct impact equipment periodic reviews.

An additional  challenge associated with this project was the fact that the manufacturing area was purchased from another company in 2010, and most of the validation documents were generated by this previous company.  This led to difficulty obtaining old records and documents, and noticeable gaps emerged between the two validation programs. As the client further developed their own validation policies and procedures, the existing documents no longer met the requirements set by the client for operating and maintaining a validated system

Periodic evaluation (or periodic review) is a stated requirement of EU GMP Annex 11 Computerized Systems and Annex 15 Qualification and validation.  ICH Q7A, the FDA Process Validation Guidance, and GAMP5 also address periodic evaluation or assessment of validated systems.

The Solution

Performance Validation (PV) provided a dedicated team to complete the periodic reviews.

This project entailed completing 49 periodic review reports for 92 pieces of equipment, 27 containing process control or computerized systems, over the course of ten months. The periodic reviews encompassed a review of all validation documents, change controls, deviations, preventive and corrective maintenance, standard operating procedures, and testing of user requirements for the systems in scope during a defined time period (the past 12 to 36 months.)

Based on the ownership and methods change, in addition to the periodic review, Performance Validation provided action items to ensure the “as-is” state of the validation documents and associated records met the current validation program.

The Results

Performance Validation completed all deliverables on-time and within budget.  The client was impressed with PV’s work and ability to deliver on-time.

The Benefits

The client had utilized a different contract group in prior years, but were dissatisfied with that group’s performance, which led them to seek out another service provider.

Performance Validation provided a win-win solution as the client was particularly satisfied with the observance that PV was operating with the client’s best interest in mind and was committed to providing the best possible product.  Performance Validation has since been awarded the 2013 periodic reviews, as well as an additional project to assist in completion of action items discovered during the 2012 reviews.

For additional information, contact:

Brad Henry
5420 W Southern Ave, Suite 100
Indianapolis, IN 46241