Interphex conference reviews validation

The issue of validation—for processes within a pharmaceutical facility—generated a buzz throughout the Jacob K. Javits Convention Center during Interphex 2005, held in New York April 26-28.

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This year’s Interphex conference and exhibition, presented by Reed Exhibitions, boasted a record of approximately 950 global companies exhibiting packaging equipment, technologies, materials, and services.

Review of GAMP Requirements for Validation was the name of an April 27 conference addressing the topic. Four speakers made presentations, led by Chris Roerig and Jim John with the Joint Equipment Transition Team. JETT is a consortium of pharmaceutical manufacturers, equipment suppliers, and consultants seeking to improve communications between users and suppliers to more effectively meet validation requirements. JETT is a special interest working group established by Good Automated Manufacturing Practice (GAMP) Americas, which is part of the International Society of Pharmaceutical Engineering.

The goals of GAMP’s most recent guide, GAMP 4, were said to be to further develop software categories, scaleable validation, and global acceptance, and to harmonize technology with other industry forums.

Roerig described end-user company responsibilities: developing a master validation plan and system-specific validation plans, conducting a supplier audit, identifying requirements specifications, and educating suppliers on end-user needs.

Ramon LeDoux of Millipore Corp.’s BioPharma-ceutical Division, explained that JETT applies GAMP to automated machinery and has released 17 User Requirement Specification (URS) documents involving equipment such as filling, labeling, vial washing, and autoclaving (sterilization).

John described himself as the last remaining founder of six-year-old JETT. He said that GAMP 5 was likely to be published by mid-2006. John reported that JETT is now focusing on risk management research requested by its membership late last year. Abbott Laboratories’ Andre Powell was recruited to lead the effort that will focus on documenting the process of evaluating risks to product safety, identity, strength, purity, and quality (SISPQ).

Terrance Petro, manager of regulatory compliance with Bosch Packaging Technology, said end-user benefits from using JETT’s approach include increased speed-to-market, smoother procurement and validation, and reduced project costs. For more information, visit —Jim Butschli

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