Supporting validation transformation from C&Q to risk-based approach

NNE streamlined Pfizer's verification systems across the customer’s global sites in a large ASTM implementation, aiming to make commissioning and qualification (C&Q) more cost effective.

When Pfizer wanted to change its traditional approach to validation, NNE’s in-depth knowledge of the new ASTM E2500 "Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment" made us the obvious choice to help out.

Once the new verification standard is rolled out, the pharmaceutical company will focus on the critical aspects of the production processes – from a science and risk-based perspective – in an effort to make the traditional commissioning and qualification more cost effective.

Focus on what is critical to the patient

In general, the pharmaceutical industry has increased spending on documenting validation activities over the past 20 years. The more detailed the documentation, the more companies felt they were in compliance. But that has changed thanks to the ASTM E2500 verification standard from 2007.

The ASTM E2500 standard focuses on the critical aspects of pharmaceutical manufacturing with regard to the patient. Because NNE is a company committed to international cooperation and standards, we were deeply involved in developing the ASTM E2500 standard.

Global roll-out

NNE’s in-depth knowledge of the new standard, and our global reach, secured us the job of streamlining Pfizer's verification systems. The project, one of the largest implementations of ASTM standards in the world, was jointly run by NNE in US and Denmark.

The NNE team worked with Pfizer Global Engineering and Global Quality to adopt a new set of verification procedures, templates and guidelines in the company’s global engineering and quality organisation. With the ASTM E2500 standard, Pfizer’s future verification approach will ensure that critical aspects of the product manufacturing process put the end-user, the patient, back in focus.

The goal was to achieve much more cost-effective verification than the traditional C&Q approach. The collaboration was a great success and will help Pfizer implement the new verification approach system in its manufacturing facilities around the world.

Quick facts

Customer

Pfizer Global Engineering

Country

USA

 

Project duration

Sep. – Dec. 2008

Services provided

Transformation from C&Q to ASTM E2500 verification