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1、European Medicines Agency Standard Operating Procedure European Medicines Agency Standard Operating Procedure Page 1/4 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: Thom
2、as L?nngren Review Date: 21-MAY-10 Signature: on file Signature: on file Date: 08-MAY-07 Date: 11-May-07 Supersedes: SOP/EMEA/0001 (16-JAN-06) 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
3、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
4、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 Trac
5、kWise 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 (provided by the IQMCo). Transmission Slip SOPs/WIN (in TrackWise; provided solely by the IQMCo). 6.
6、 Related documents SOP/EMEA/0037: Publication or withdrawal of SOPs/WIN WIN/EMEA/0035: Creating and maintaining SOP/WIN folders in EDMS WIN/EMEA/0036: Creating flow charts WIN/EMEA/0053: Use of TrackWise software for SOP/WIN recording and tracking 7. Definitions EMEA Bodies: Management Board, Scient
7、ific Committees, Working Parties, Scientific Advisory Groups, etc. HoU/HoS: Head of Unit/Head of Sector IQMCo: IQM Co-ordinator or delegate ManualCo: IQM Manual Co-ordinator or delegate PUBLIC Page 2/4 SOP/EMEA/0001, 22-May-07 SOP: Standard Operating Procedure - Detailed, written instructions to ach
8、ieve uniformity of the performance of a specific process; the instructions usually cover more than one task or area within the Agency, Unit, or Sector. TrackWise: Software for the tracking of processes and the creation and archiving of related records and associated documents. The SOP/WIN Management
9、 module is intended for the recording and tracking of SOPs and WIN. WIN: Work Instructions Detailed descriptions of how to perform and record tasks; they may be, for example, detailed written descriptions, flow charts, checklists, pictures, or combinations thereof (definition adapted from ISO/TR 100
10、13:2001 Guidelines for quality management system documentation) 8. Process Map(s)/ Flow Chart(s) 1. Determine need for new SOPAssign Lead author Define scope, title and consultation and publication statusAppoint drafting teamDetermine Approver2. Inform Unit IQM Co by e-mail3. Assign SOP 0#ffff66Doc.
11、 No.Create e-folder structure & process map template (WIN/EMEA/0035) Create TrackWise record & SOP template (WIN/EMEA/0053)Forward automated e-mail to Lead author4. Create Process Map (WIN/EMEA/0036)5. Complete SOPDevelop separate forms/templatesSTART6. Inform IQMCo and agree on duration of
12、consultation7. Check SOP formatUpdate SOP statusUpdate TrackWise record (WIN/EMEA/0053)10. Publish on IQM web page on EMEAPlusInform EMEAPlus news editors13. Evaluate and implement commentsCheck and finalise Process Map, SOP and related forms/templatesInform IQMCo16. Update SOP statusPrint hard copy
13、 Update TrackWise record and generate transmission slip (WIN/EMEA/0053)17. Sign SOP (Lead author)19. Go to SOP/EMEA/003718. Read and sign SOP (Approver)END15. Implement corrections, if required14. Carry out QC check12. Send Comments to Lead Author11. Announce on EMEAPlus news page8. Is consultation
14、with EMEA Bodies required?9. Refer SOP to EMEA BodiesNoYes PUBLIC Page 3/4 SOP/EMEA/0001, 22-May-07 9. Procedure Step Action Responsibility 1 Determine need for a new SOP. Assign Lead author of SOP. Define scope and purpose of SOP with Lead author. Appoint drafting team having a good knowledge of th
15、e process. If cross-Sector/Unit representation is necessary, consult with other HoS to appoint team members. Determine who will be the Approver of the SOP. Determine the consultation status, i.e. whether the SOP will be made available only for internal EMEA staff consultation or will be extended to
16、other EMEA Bodies. Determine publication status of final SOP, i.e. PUBLIC (for publication on intranet and external web site) or CONFIDENTIAL (for publication on intranet and title only published on external web site). HoU/HoS 2 Inform Unit IQMCo by e-mail of SOP title, consultation status, publicat
17、ion status, and Lead author, drafting team and approver names. Lead author 3 Verify if any other SOP or WIN for similar processes at the EMEA exists or is under development to avoid duplication or divergence. If not, assign SOP document number, create SOP-specific folder and process map template in
18、EDMS (refer to WIN/EMEA/0035), create new record and SOP template in TrackWise, and forward automated email to Lead author (refer to WIN/EMEA/0053). IQMCo 4 Prepare process map in PowerPoint for the process to be documented (refer to WIN/EMEA/0036) using the blank template provided by the IQMCo. Sav
19、e all versions of the document in the SOP-specific folder provided. Lead author/drafting team 5 Complete SOP template provided by the IQMCo. Describe the process in clear and concise steps, based on the process map. Refer to documents required for the process, using the document title/number without
20、 version number. Insert a black and white copy of the updated process map in the SOP (refer to WIN/EMEA/0036). Save all versions of the SOP in the SOP-specific folder provided. If the process described in the SOP requires the use of templates/forms, develop them in parallel to the SOP, NOT as append
21、ices to the SOP. Refer to them in the SOP, and save the templates/forms in the SOP-specific folder. In case of difficulty with any part of this Step, seek assistance of the Unit IQMCo. Lead author/drafting team 6 When drafting is complete, inform the IQMCo and discuss the required length of consulta
22、tion, i.e. 2 or 4 weeks of internal EMEA staff consultation (the length of consultation depends on the urgency to publish and the degree of cross-Agency consultation required). When other EMEA bodies need to be consulted, the length of consultation may be longer than 4 weeks. Lead author 7 Open the
23、SOP record in TrackWise (WIN/EMEA/0053). Check that SOP has been completed according to the instructions in the template. Complete checklist in TrackWise. Update status of SOP to CONSULTATION (CONFIDENTIAL) in IQMCo PUBLIC Page 4/4 SOP/EMEA/0001, 22-May-07 Step Action Responsibility template and che
24、ck in to EDMS. Update the TrackWise record (refer to WIN/EMEA/0053) with the agreed consultation details. (Note: TrackWise sends automated notifications to Lead author and ManualCo.) 8 If the SOP requires consultation with EMEA Bodies, go to Step 9. If the SOP does not require consultation with EMEA
25、 Bodies, go to Step 10. IQMCo 9 Refer SOP and forms/templates, if applicable, to EMEA Bodies for the period of consultation as agreed with the IQMCo in Step 6. Lead author 10 Create a link to the copies of the SOP and forms/templates, if applicable, on EMEAPlus IQM web page. Inform the News Editors
26、to advertise the SOP consultation on EMEAPlus news page and provide a contact name and the deadline for consultation. ManualCo 11 Announce SOP consultation on EMEAPlus news page. EMEAPlus news editors 12 Review draft SOP and provide Lead author with comments by email. EMEA staff 13 Evaluate comments
27、 from internal staff and, if applicable, EMEA bodies. Implement appropriate suggested improvements in the SOP. Check and finalise Process Map, SOP and forms/templates, if applicable. Inform IQMCo when ready. (Note: TrackWise sends automated notifications to Lead author and IQMCo at the end of the co
28、nsultation and when there are delays in finalising a SOP after consultation.) Lead author/drafting team 14 Carry out quality check (use checklist in WIN/EMEA/0053) and request Lead author to make corrections, if required. IQMCo 15 Make necessary corrections to SOP and forms/templates, if required. L
29、ead author 16 Update status of SOP as informed in Step 2, print hard copy and check in to EDMS. Open the SOP record in TrackWise, document quality check and update required fields. Generate transmission slip. (Refer to WIN/EMEA/0053.) Forward SOP and transmission slip to Lead author. IQMCo 17 Sign SOP and transmission slip. Forward to Approver. Lead author 18 Read SOP. Sign SOP and transmission slip. Forward to IQMCo. Approver 19 Refer to SOP/EMEA/0037. IQMCo 10. Records Electronic records of SOPs are generated and saved in TrackWise. Electronic documents are saved in EDMS.