Pharmaceutical Technology May 2003
May 2003 | Volume , Issue
The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.
Training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. The author discusses various approaches that may be taken to ensure a successful training session.
Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.