Special GMP Training – Technology and Plant Design for Active Substance Manufacturers

An in-house training session on topics of plant design and qualification was held on 11 and 12 May 2017 in the large gempex conference room at the Mannheim location. The participants were quality managers from the Global Quality Compliance and Quality Assurance Ludwigshafen units of the BASF Nutrition & Health division that produces and markets APIs and excipients.

Tailored to the specific needs of the participants, the goal of the course was to enable a moderated, open exchange of experiences with technical support, and to provide an update on current requirements according to rules and regulations as well as the corresponding solutions implemented in practice: What is required? What is the state of the art? Where is the position good, and where can improvements be made? The following topics were on the agenda

  • GMP rules and regulations update
  • Compliant design in theory and practice
  • Idealised project schedule for a new plant
  • Status quo qualification
  • BASF qualification concept
  • Utilities to meet the requirements
  • Maintenance and upkeep of compliance

 “It was good to extensively and specifically discuss the topics separately from individual projects, to coordinate and to exchange information on BASF practices,” says Boris Glasbrenner, Manager API / Chemistry at gempex, who moderated and provided technical support for the event jointly with Ralf Gengenbach, Managing Director of gempex. A compact training session was presented for each thematic block.

Specific questions related to current projects could be subsequently debated, practical examples identified, and empirical values and case studies discussed. The participants were joined by gempex colleagues who are assisting with current BASF projects.   It was a successful event with added value for all participants.

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