Treatment of variations related to replacement of acetonitrile in the route of synthesis / analytical methods
(27/03/09) As a consequence of the global shortage of acetonitrile, companies are seeking to use alternative solvents or analytical methods to minimise the impact of this shortage. Certificates holders are reminded that such changes will require the submission of variation applications together with appropriate supporting data. The Certification of Substances Division will assess any resulting revision of CEP applications as a fast-track procedure (within 1 month of receipt), provided no other changes are included in the request for revision. 作为乙腈全球性短缺的后果,公司使用替代溶剂或分析方法来减少这个短缺的影响。提醒证书持有者这样的变更需要提交变更申请,并同时提供适当的支持性数据。如果在所要求的修订中没有包括其它的变更,物质证书部会采用快速程序(接收后1个月内)来评审CEP的修订申请。