An Open Forum Sponsored by APQ Section at the AAPS Annual Meeting, Denver, CO
Thursday, Oct. 25, 2001, Afternoon Session

Validation of Analytical Instruments: A Search for Scientific Rationale

Summary: Current regulations require that the analytical instruments used in today's laboratories be validated. What are the drivers for these requirements? What is considered a full validation? Can instrument validation be cut into parts and end users and instrument manufacturers be responsible for their parts? Are there uniform requirements for instrument validations? Would a validation performed on one piece of equipment be the same or similar at different laboratories? Would two users give the same answer when asked above questions? And would end user, QA unit, instrument manufacturer and validation consultants agree on the answers to these questions? Such questions go through the minds of most scientists in analytical and bioanalytical laboratories who must perform these validations. Without having scientifically-based consistent practices, can we continue to make progress and benefit from the validation efforts?

It seems we must be at the infancy of instrument validation if so many questions are in the minds of the responsible scientists. It is reminiscent of the days prior to reaching a consensus on analytical or bioanalytical methods validations. With such a variety of instruments in the laboratories, would we ever reach a consensus on how to validate them, or is validation the right terminology for qualifying an instrument for analytical work? The answer is clear - we would never reach a consensus if the users do not find the scientific rationale for performing the validation. Scientific rationale would also increase knowledge in instruments and provide a solid basis for coming to a consensus on meeting the regulatory requirements.

The Open Forum will bring in views from several users on their current scientific basis for performing validations. If truly no scientific basis exists, then we will hear from the users on what basis they perform validations. Prior to the meeting, we would seek the involvement of users at large and get their views and questions through the Internet. At the forum we would discuss everyone's views and make an effort to find common ground for a scientific basis for instrument validations. The open forum is to start the dialog. The objectives would be met if the dialogs lead to an extended workshop for generation of a consensus on Analytical Instrument Validation.

Format of the session: Main focus of this forum is to interact with the users at the open forum and through electronic media. One and a half hour is set aside at the forum for open discussion on the issue. Panel will consist of six (6) speakers from the pharmaceutical industry, instrument manufacturer, USP and FDA.

Prior to the meeting we are seeking your input on the subject. Please forward your comments and questions to the organizers, given below. Your comments and questions will be discussed at the forum, along with the live questions from the audience.

Organizers:
Surendra K. Bansal, Ph.D.
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, NJ 07110
Email: surendra.bansal@roche.com
Tel: 973-235-5919

Marta Hamilton, Ph.D.
Gilead Sciences, Inc.
Biopharmaceutics
2860 Wilderness Place
Boulder, CO 80301
email: mhamilton@gilead.com
Tel: 303-546-7788