WP17 Chemical Hazard Identification, Classification and Communication
Wednesday, 16 November 2005: 8:00 AM - 6:30 PM in Exhibit Hall

(ALS-1117-729076) Environmental Hazard Assessment Strategies for Materials Used in Global Manufacturing Operations.

Alston, S¹, Hannah, R², ¹ GlaxoSmithKline, Research Triangle Park, NC, USA² GlaxoSmithKline, Philadelphia, PA, USA

ABSTRACT- As part of an overall materials hazard assessment strategy, GSK has been developing ecotoxicity and environmental fate data on process materials, active ingredients, and drug product excipients. Updated hazard assessments were needed for GSK supply chain materials after the merger between GlaxoWellcome and SmithKline Beecham. A coordinated strategy was developed incorporating testing schemes, financial support, identification of key manufacturing processes, associated materials and transfer sites, regular communication with team members, and progress reports. To efficiently assess these materials for environmental hazards, a tiered approach was applied. Material assessments were prioritized based on available data, preliminary ecotoxicity QSAR estimates, timing of process transfers, and quantities utilized within the supply chain. Preliminary assessments were conducted and data gaps identified. Gaps were closed through testing schemes involving fundamental subsets of environmental fate and effects tests based on material class (actives, reagents, excipients, etc.).Test data were compiled to produce environmental hazard assessments which were distributed through the supply chain via GSK Hazard Assessment and Communication documents. Overall strategy elements, prioritization criteria, testing subsets and example data sets will be presented.

Key words: environmental hazard assessment, environmental fate and effects, pharmaceuticals