文档介绍：European Medicines Agency Standard Operating Procedure
Title: Preparation and approval of new Standard Operating Procedures PUBLIC Document no.: SOP/EMEA/0001 Lead Author Approver Effective Date: 22-MAY-07 Name: John S. Forte Name: Thomas Lönngren Review Date: 21-MAY-10 Signature: on file Signature: on file Supersedes: SOP/EMEA/0001 (16-JAN-06) Date: 08-MAY-07 Date: 11-May-07
1. Purpose To enable the development and presentation of Standard Operating Procedures (SOPs) at the EMEA in a consistent way by the use of process maps and the EMEA SOP template. An existing SOP should be revised according to the SOP on Review and Revision of Effective SOPs (SOP/EMEA/0013). 2. Scope This SOP applies to all members of staff in EMEA Directorate, Units and Sectors. 3. Responsibilities Each Unit and Sector Head under the responsibility of the Executive Director must ensure that this procedure is adhered to within their own unit or sector. The responsibility for the execution of each step of this procedure is identified under 9. Procedure. 4. Changes since last revision Revision of SOP to reflect changes following introduction of TrackWise software for recording and tracking of SOPs and WIN. 5. Documents needed for this SOP SOP Template in MS Word (in TrackWise; provided solely by the IQMCo). Process Map Template in MS PowerPoint (provi