Rubrik: GMP / GLP / GCP
(Treffer aus pharmind, Nr. 05, Seite 718 (2014))
Hildebrandt K | Steines S | Brock W
Need for Dedicated Equipment? / Manufacturing of Antineoplastics and Other Hazardous Substances · Hildebrandt K, Steines S, Brock W · 1
Dottikon Exclusive Synthesis AG, Dottikon, Switzerland und 2
Brock Scientific Consulting, Montgomery Village, MD, USA
A major concern related to the production of active pharmaceutical agents (APIs) and pharmaceutical intermediates is the cross-contamination of subsequently manufactured products with substances that are highly toxic or that have high biological activity. This issue is addressed in Good Manufacturing Practice (GMP) guidelines. EudraLex [ 1 ], a compendium of Good Manufacturing Practices (GMPs), clearly states that contamination of a starting material or of a product by another material or product must be avoided. The risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, vapors, etc. from materials and products in process as well as from ...