Standard operating procedure Title: Preparation and approval of new standard operating procedures Status: PUBLIC Document no.: SOP/EMA/0001 Approver Effective date:10-jul-2013 Name: Mario Benetti Name: Guido Rasi Review date:10-jul-2016 Signature: On file Signature: On file Supersedes: SOP/EMA/0001 (21-MAY-10) Date: 10-Jul-13 Date: 10-Jul-13 TrackWise record no.: 3878 1. Purpose To describe the procedure for developing a new standard operating procedure. An existing SOP should be revised according to the SOP on Review and revision of effective standard operating procedures (SOP/EMA/0013). 2. Scope This SOP applies to all lead authors involved in SOP/WIN drafting and to all Heads of Sector and Section Heads. 3. Responsibilities Each Head of Unit, Head of Sector and Section Head under the responsibility of the Executive Director must ensure that this procedure is adhered to within their own unit, sector or section. The responsibility for the execution of a particular part of this procedure is identified in the right-hand column of section 9. 4. Changes since last revision Revision of step 3 to adapt the instructions to the use of a MS Word SOP template instead of a template provided by TrackWise. Revision of step 4 to adapt the instruction with the use of MS Visio instead of MS Power Point to create flow charts. Replacement of references to EDMS by DREAM and updating of instructions to reflect DREAM. 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu An agency of the European Union European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
5. Documents needed for this SOP SOP template in MS Word (provided solely by the ). Flow chart template in MS Visio (provided solely by the ). SOP_WIN transmission slip (provided solely by the ). 6. Related documents SOP/EMA/0037: Publication of, and training on standard operating procedures and work instructions WIN/EMA/0035: Creating and maintaining SOP/WIN folders in DREAM WIN/EMA/0036: Creating flow charts for standard operating procedures and work instructions WIN/EMA/0053: Use of TrackWise software for SOP/WIN recording and tracking 7. Definitions DREAM: Document records electronic archive management system EMA bodies: Management Board, scientific committees, working parties, scientific advisory groups, etc. of the European Medicines Agency HoS/SH: Head of Sector/Section Head : Unit IQM co-ordinator or delegate ManualCo: IQM manual co-ordinator or delegate SOP: Standard operating procedure - Detailed, written instructions to achieve uniformity of the performance of a specific procedure; 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 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 SOP/EMA/0001,10-Jul-13 Page 2/6
8. Process map(s)/ flow chart(s) START 1. Determine need for SOP Assign lead author Define scope and title Appoint drafting team Assign approver Determine consultation status and publication status 11. Announce on intranet news page 12. Evaluate and implement comments Check and finalise flow chart, SOP and related forms/templates Inform 2. Inform Unit IQM Co 13. Carry out QC check 3. Assign SOP Doc. No. Create e-folder structure (WIN/EMA/0035) Create TrackWise record (WIN/EMA/0053) Create SOP flow chart template (WIN/EMA/0036) Send e-mail to Lead author 4. Create flow chart (WIN/EMA/0036) 14. Implement corrections, if required 15. Update SOP status Print hard copy Update TrackWise record (WIN/EMA/0053) Generate transmission slip Categorise in activity area/type 5. Complete SOP Develop separate forms/ templates 16. Sign SOP (lead author) 6. Inform 17. Read and sign SOP (approver) 7. Check SOP format Update SOP status Update TrackWise record (WIN/EMA/0053) 18. Go to SOP/EMA/0037 8. Is consultation with EMA bodies required? END Yes No 9. Refer SOP to EMA bodies 10. Publish on IQM web page on intranet Inform intranet news editors SOP/EMA/0001,10-Jul-13 Page 3/6
9. Procedure Step Action Responsibility 1 Determine need for a new SOP. HoS/SH Assign lead author of SOP. Define scope, purpose and title of SOP with lead author. Appoint drafting team having a good knowledge of the procedure. If cross-section/sector/unit representation is necessary, consult with other SH/HoS to appoint team members. Determine who will be the approver of the SOP (Executive Director, HoU, HoS or SH). Determine the consultation status, i.e. whether the SOP will be made available only for internal EMA staff consultation or will be extended to other EMA bodies. Determine publication status of final SOP, i.e. PUBLIC or CONFIDENTIAL. Note: All documents should be PUBLIC (for publication on intranet and external web site). In case the document contains sensitive information, the document can be CONFIDENTIAL (for publication on intranet only). In case of difficulty with any part of this step, seek assistance of the. 2 Inform by e-mail of SOP title, consultation status, publication status, and lead author, drafting team and approver names. 3 Verify if any other SOP or WIN for similar procedures at the EMA exists or is under development to avoid duplication or divergence. If not, assign SOP document number and create SOP-specific folder in DREAM (refer to WIN/EMA/0035). Create new record in TrackWise (refer to WIN/EMA/0053). Create SOP and flow chart templates in DREAM (refer to WIN/EMA/0035). When completed, send e-mail to lead author with the link to the SOPspecific folder in DREAM.. 4 Prepare flow chart in MS Visio for the procedure to be documented (refer to WIN/EMA/0036) using the blank template provided by the. Save all versions of the document in the SOP-specific folder provided. 5 Complete SOP template provided by the. SOP/EMA/0001,10-Jul-13 Page 4/6
Step Action Responsibility Describe the procedure in clear and concise steps, based on the flow chart. Refer to documents required for the procedure, using the document title/number without version number, and provide details of their location (e.g. hyperlinked URL). Ensure that all functions identified as responsible for specific actions described in the SOP have been consulted and engaged in the drafting of the SOP. Paste the flow chart as a picture (enhanced metafile) in the SOP (refer to WIN/EMA/0036). Save all versions of the SOP in the SOP-specific folder provided. If the procedure described in the SOP requires the use of templates/forms, develop them in parallel to the SOP, NOT as appendices to the SOP. Refer to them in the SOP, and save the templates/forms in the SOPspecific folder. In case of difficulty with any part of this step, seek assistance of the. 6 When drafting is complete, inform the and discuss the required length of consultation. Note: For a new SOP, the length of consultation is 4 weeks; The period of consultation of EMA bodies may be longer than the standard 4 weeks (there is no maximum length in this case). 7 Check that SOP has been completed according to the instructions in the template and complete checklist in TrackWise (refer to WIN/EMA/0053). Update status of SOP to CONSULTATION (CONFIDENTIAL) in template and check in to DREAM. Update the TrackWise record (refer to WIN/EMA/0053) with the consultation details. Note: TrackWise sends automated notifications to lead author and ManualCo. 8 If the SOP requires consultation with EMA bodies, go to step 9. If the SOP does not require consultation with EMA bodies, go to step 10. 9 Refer SOP and forms/templates, if applicable, to secretariats of EMA bodies to initiate consultation. 10 Publish the SOP on the intranet IQM web page. ManualCo Inform the News Editors to advertise the SOP consultation on the intranet news page and provide the deadline for consultation. SOP/EMA/0001,10-Jul-13 Page 5/6
Step Action Responsibility 11 Announce SOP consultation on the intranet news page. Intranet news editors 12 On receipt of comments from staff and, where applicable, from EMA bodies, acknowledge receipt by e-mail. Evaluate comments and implement appropriate suggested improvements in the SOP. Check and finalise flow chart, SOP and forms/templates, if applicable. Inform when ready. Note: TrackWise sends automated notifications to lead author and at the end of the consultation and when there are delays in finalising a SOP after consultation. 13 Carry out quality check (use checklist in WIN/EMA/0053) and request lead author to make corrections, if required. 14 Make necessary corrections to SOP and forms/templates, if required. 15 Update status of SOP to agreed publication status as informed in step 2. Print hard copy. Check in to DREAM. Open the SOP record in TrackWise, document quality check and update required fields (refer to WIN/EMA/0053). Prepare the SOP_WIN transmission slip. Categorise the SOP in the relevant activity area and type for web publication, and document in the transmission slip. Forward SOP and transmission slip to lead author. 16 Sign SOP and transmission slip. Forward to approver. 17 Read SOP and sign SOP and transmission slip. Approver Forward to. 18 Refer to SOP/EMA/0037. 10. Records Electronic records of SOPs are generated and saved in TrackWise. Electronic documents are filed, in DREAM under: Cabinets/06. Corporate governance/06.2 Integrated Management System/2. IMS Manual/5. SOPs and WINs SOP/EMA/0001,10-Jul-13 Page 6/6