SOP:11:VL:023:02:NIBT PAGE 1 of 9

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1 SOP:11:VL:023:02:NIBT PAGE 1 of 9 Northern Ireland Blood Transfusion Service STANDARD OPERATING PROCEDURE (Operational Copy) Document Details Document Number: SOP:11:VL:023:02:NIBT Supersedes Number: SOP:11:VL:023:01:NIBT No. of Appendices: NONE Document Title: PREPARING A MAPPING REPORT Prepared By: Eileen Taylor Job Title: Validation Officer Department: REGULATORY AFFAIRS & COMPLIANCE Document Authorisation/ Issue & Implementation Prepared By: E Taylor Approved By: A Macauley Regulatory Affairs & Compliance Manager Date: Date: ISSUE DATE: 4 JANUARY 2013 EFFECTIVE DATE: 16 JANUARY 2013 CROSS REFERENCES This SOP refers to the following documents: Doc. Doc. Title Type No. FORM DD:863 Temperature Mapping in Progress Form FORM DD:1125 Mapping Report Cover Sheet FORM DD:1126 Mapping Report Spine Sample FORM DD:1193 Temperature / RH Mapping Report FORM DD:1392 Mapping Report Issue Notice FORM DD:1393 Mapping Report Recall Notice FORM DD:1394 Mapping Report Distribution History FORM DD:1395 Mapping Report Final Issue Notice FORM DD:1396 Mapping Report Tracking Sheet when inside R A & C Department FORM DD:1398 Guidance for completing the Justification section of the Mapping Report SOP VL:016 To Run A Session Using Ellab TS Pro Probes. SOP VL:024 Retrieving REES CENTRON results for use in Temperature Mapping

2 SOP:11:VL:023:02:NIBT PAGE 2 of 9 Key Change from Previous Revision: Addition of reference to the Mapping Report Tracking system and explanation of how it is to be used, section Inclusion of FORM:DD:1398 Guidance for completing the Justification section of the Mapping Report 1 RESPONSIBILITY 1.1 The Validation Officer and Compliance Officer/s have responsibility for preparing mapping reports. 1.2 The Compliance Officer has responsibility for making the Validation Officer or deputy aware of any problems or concerns with the Ellab equipment and ValSuite software during its use which would impact upon a mapping report. 1.3 Heads of Departments or deputy have responsibility for reviewing the mapping report to confirm accuracy of acceptable temperature ranges, use of equipment etc. and to ensure temperature critical storage conditions comply with the current regulatory requirements and industry guidance. 1.4 Heads of Departments or Deputy are responsible for reviewing the current position of the continuous monitoring probe in light of current mapping results. 1.5 Document Control Officer or Deputy has responsibility for activating approved mapping reports on Q PULSE. 1.6 The Regulatory Affairs & Compliance Manager, Heads of Departments or Deputy and the Validation Officer have responsibility for approving the mapping report both hard copy and on Q Pulse. 1.7 Heads of Departments or Deputy have responsibility for filing and storing mapping reports and ensuring they are available for audit. 2 INTRODUCTION 2.1 GENERAL The Mapping Report requires the completion of the current version of FORM:DD:1193 Temperature / RH Mapping Report and summarises the information obtained in the Temperature/RH Mapping including; acceptance criteria, minimum, maximum and average results for the area mapped and the ambient environment; highlights of deviations from the acceptance criteria and a correlation with the continuous temperature monitoring results for the same period.

3 SOP:11:VL:023:02:NIBT PAGE 3 of The report aims to allow the equipment owner to review and approve the mapping data, confirm that the equipment/area continues to operate satisfactorily and the appropriateness of the positioning of the continuous monitoring probe Temperature mappings are carried out as per SOP:VL:016 To Run A Session Using Ellab TS Pro Probes. 2.2 CLINICAL RELEVANCE/ PURPOSE OF EXAMINATION Temperature Mapping is a requirement of GMP. 2.3 PRINCIPLE OF EXAMINATION The summary of information provided by the Mapping Report reduces the time required to review and approve the mapping. 3 HAZARD AND SAFETY PRECAUTIONS 3.1 It is recommended that individuals using display screen equipment e.g. computer screens do not remain in the same position for prolonged periods of time, ensure that they sit in a comfortable position and have adequate work space. 4 MATERIALS 4.1 EQUIPMENT AND SPECIAL SUPPLIES Current version of FORM:DD:1193 Temperature/RH Mapping Report Form, PC, Mapping data 4.2 SPECIMEN REQUIREMENTS AND MEANS OF IDENTIFICATION Not Applicable. 4.3 REAGENTS, STANDARDS OR CALIBRANTS AND INTERNAL CONTROL MATERIALS Not Applicable. 5 CALIBRATION Not Applicable.

4 SOP:11:VL:023:02:NIBT PAGE 4 of 9 6 PROCEDURE 6.1 Download the current version of FORM:DD:1193 Temperature/RH Mapping Report Form from Q-Pulse. 6.2 Save the document into the Draft Mapping Reports Folder for that year and department in the Ellab folder in the I Drive using the appropriate mapping number and name of equipment/area mapped as the title of the saved document e.g. VAL:MAP:BG:12:MR:002:01:NIBT, BGRL Nuve RT Incubator Complete each section of the mapping report. o o o Section 1; type in the facility /equipment name, the REES point number or similar probe number or logger serial number, the Q- Pulse number for the equipment mapped, and the location of the equipment or area mapped e.g. Hospital Services Issue Lab, NIBTS HQ Section 2; complete the planned normal use, the acceptance range for the temperature and for RH if appropriate; this would be expected to be the same as the temperature monitoring probe temperature range Section 3; type in the mapping report number in the format required VAL:MAP:BG:12:MR:002:01:NIBT, the date mapped, the reason for mapping e.g. annual mapping, post repair of compressor, and the fill level. Mapping Results Box. When completing the mapping results box first state whether the results all met or did not meet the acceptance criteria e.g. all results met the acceptance criteria or 8 of the 9 positions met the acceptance criteria. List the figures for the Study Min, Max and Average in o C List the figures for the Ambient Min, Max and Average in o C Some mappings include more than one area such as for Hospital Services Component Processing Labs. There are 3 separate areas; the main lab, the pooling room and the checking room. The min, max and average and the correlation for each of these areas is reported in the mapping results section of the Mapping Report. The General Stores in NIBTS HQ requires Relative Humidity mapping for the area of rack shelving that holds bag labels. The min, max & average for RH is included in the results box. Correlation: complete the correlation for temperature. As appropriate obtain the monitoring probe data for the period of the study according to SOP:VL:024 Retrieving REES CENTRON results for use in Temperature Mapping, or obtain the Comark logger data from the user department. Create a table in Microsoft EXCEL with the headings; Time, REES/other probe number and whether in liquid or air (or Comark

5 SOP:11:VL:023:02:NIBT PAGE 5 of 9 logger), Ellab probe position number used and fill in the table for the period of the study. The REES printout will provide results every 4 hours unless there has been an event when extra data will be available in print. Use the 4 hr. data usually 12midnight, 4am, 8am, 12midday, 4pm, 8pm as appropriate within the period of the study. Fill in the table with the data for the same time for the Ellab probe positioned closest to the REES type probe. See screen dump below. If a Comark logger or similar is used, complete the table with results from the Comark logger and Ellab probe nearest to it. See screen dump below To correlate the data click on the fx, the Insert Function icon This brings up the Insert Function box choose CORREL from the select a function scroll down options available

6 SOP:11:VL:023:02:NIBT PAGE 6 of 9 The Functions Arguments box pops up. Select the data from one column as Array 1 and the corresponding data from the other column as Array 2. Click on OK and the correlation result is given. Change result to 2 decimal places Add this correlation result into the mapping results box on the Mapping Report. There is no correlation done for RH. Continue to complete the Mapping Report Form. The Mapping outcome box is completed by the user department stating whether the mapping outcome is acceptable and comments are to be made where there are deviations and these signed & dated.

7 SOP:11:VL:023:02:NIBT PAGE 7 of 9 o Section 4 Deviations & Outcomes / Actions. Note any deviations from the acceptable temperature/rh range as recorded in Section 2. The deviations are to note; the temperature (or RH), the duration of the temperature/rh excursion and how often it occurred any pattern noticed e.g. every 6 hrs for 10 minutes, which may correspond to the compressor defrost cycle. The deviation outcomes/actions are to be completed as stated on the form by the user department then signed & dated. o Section 5 the Head of Department or deputy will confirm the position of the continuous temperature monitoring probe is appropriate for the current mapping. This justification is to include the rationale for the probe positioning with consideration to the hottest and coldest positions, the nature of the GMP product stored and its requirements with reference to any restrictions on probe positioning. Where probe positioning cannot meet the requirements for continuous temperature monitoring, consideration should be given to alteration of the the temperature range for the continuous temperature monitoring probe to take into account the offset from this probe and the max or min mapping temperature position as appropriate. Guidance on probe positioning and determining temperature ranges is provided in FORM DD:1398 Guidance for completing the Justification section of the Mapping Report. o Section 6 states who carried out the mapping who completed the mapping report form and who checked it and is required to be signed & dated. o Section 7 approval for the Mapping Report The information that comprises the complete Mapping Report are; the Mapping Report, the Ellab mapping data printout with the Ellab probe data and statistics, logger and sensor identification and settings and an audit trail. To this is added; the Event Log; FORM:DD:863 the Temperature Mapping in Progress form placed on the door/s of the area being mapped the REES. The Comark or other monitoring probe data for the mapping period, the correlation for the mapping probe and the monitoring probe and the calibration certificates for the mapping probes. o The approval is signed in the order of User Department, the Validation Officer and the Regulatory Affairs & Compliance Department Manager or deputy The procedure for the Mapping Report Tracking System is described below For each Mapping Report create; 1. An entry in the tracking sheet for mapping reports when inside RA&C dept. using (FORM DD:1396 Mapping Report Tracking Sheet when inside R A & C Department).

8 SOP:11:VL:023:02:NIBT PAGE 8 of 9 2. A distribution list using (FORM:DD: Mapping Report Distribution History). The Head of the User Department or mapping report signee who may be the deputy HOD, would normally be the only name on the distribution list Create, Issue and Recall notices (FORM:DD:1392 Mapping Report Issue Notice and FORM:DD:1393 Mapping Report Recall Notice ) The Mapping Report will be issued along with an issue notice (FORM:DD:1392) to the Head of Department or deputy The Issue notice will be signed by the Head of the user department or deputy on their behalf and returned to RA&C office to the Compliance Officer or Validation Officer where it will be filed in a Mapping Report Tracking System file The Recall notice (FORM:DD:1393) will be stored in the file which will be checked daily for any recalls due on that date If the Mapping Report has not been returned within 1 week a Recall notice will be issued If the recall notice is not returned within 2 days of issue a notification will be sent to request urgent action to complete the Mapping Report. If they do not respond within 1 week of the recall notice being issued an incident will be raised Issue, Recall and Distribution sheets will be stored together in the file when the reconciliation process is completed Upon return of the Mapping Report to RA&C, FORM:DD:1396 is again used to track the mapping report movement within RA&C dept.. The Validation Officer checks and approves the user department comments and justification and if suitable approves the report The Mapping Report is then passed onto the RA&C Manager or Quality manager as deputy to give final quality approval and this activity is noted on FORM:DD: Upon final approval of the Mapping Report it is returned to the Compliance Officer or the Validation Officer for scanning and any attached pages which are then sent to the Document Control Compliance Officer to be placed onto Q-Pulse Validation Draft Register and approvers notified. The mapping report is then returned to the user department for storage using Final Issue Notice FORM:DD:1395. The completed form is then brought back to RA&C office for Final reconciliation. 6.4 When the mapping report has been approved on Q-Pulse the Document Control Officer or Compliance Officer will activate the document and move it to the Q-PULSE register for Validation: Mapping Reports.

9 SOP:11:VL:023:02:NIBT PAGE 9 of FILING OF THE MAPPING REPORT Once the mapping report has been returned to the user department the document is to be retained (complete) and to be available for inspection in keeping with NIBTS policy Mapping reports are held in presentation ring binders (preferably red) using FORM:DD:1125 Mapping Report Cover Sheet as the front cover for the file listing the mapping reports within. Use FORM:DD:1126 Mapping Report Spine Sample for the spine label The user department maintains responsibility for the mapping report filed in the presentation ring binder. 6.6 LIMITATIONS OF THE EXAMINATION It is good practice to complete one mapping report at a time as soon as the mapping probes have been read to avoid any possibility of mixing up mapping results and to ensure the report is completed in good time normally within 7 days of the end of the mapping. Before starting to write a mapping report it is important to have all information required immediately to hand. 7 RESULTS Not Applicable.