Canadian Blood Services Societe canadienne du sang

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1 Canadian Blood Services Societe canadienne du sang 1800 Alta Vista Ottawa, ON K1 G 4J5 T F CBS Control #: CBS5613 HPFB File #: C REF: H-1213-DAR Ms. Brenda Redmond Operational Manager Atlantic Operational Centre Health Products and Food Branch Inspectorate Su ite 1625, 16 th Floor 1505 Barrington Street Halifax, Nova Scotia B3J 3Y6 Dear Ms. Redmond: Re: Responses to the Health Canada GMP Inspection of the Dartmouth Production and Distribution Site February 2013 The following are the actions undertaken by Canadian Blood Services in response to the observations contained in the Health Canada Exit Notice. 1. The generic Installation Operational Qualification (IOQ) protocol template utilized to perform equipment 10Qs did not always provide sufficient direction to personnel, to provide assurance that the 10Q was executed accurately, occurrences were handled consistently, and the required documentation was Included as part of the 10Q. a. The requirement to assess the training program or plan and matrices was vague and did not provide clear direction regarding what should be assessed and which personnel are involved. There was no mechanism to document the records reviewed to meet these criteria. Also the objectives of Section 12.0 of version 3.0 of the protocol were not met by the method requirements (NDAS 10Q). b. There was limited direction on how to document and handle inconsistencies between the requirements of the protocol and the actual equipment being qualified. For example, the walk-in freezer had a combination of a switch and fuses, rather than a circuit breaker. The comments section of the protocol was utilized to document this inconsistency. However the criteria listed as "The circuit breaker is dedicated to the unit" was checked off as "yes" even though the unit did not have a circuit breaker.

2 Canadian Blood Services c. There was limited direction in the protocol to identify what information and documentation was required to support that the qualification had been conducted accurately. For example: i. When a temperature probe falls to function, it was unclear whether the data from this probe should be included in the qualification or raw data information. ii. iii. The requirement to initiate deficiencies. e.g. temperature probe failure. Documentation supporting the completion of a task. e.g. testing of the panic button. Combined Response - Observation 1 a-c: Canadian Blood Services will assess the current installation and operational qualification protocol template to ensure sufficient guidance has been incorporated to satisfy validation principle requirements, including but not limited to the requirements for supporting evidence. The protocol template will be revised by to address issues identified in subobservations 1 a, 1 band 1 c. Generic directions will be modified, where applicable, to provide detailed instructions in order to mitigate potential misinterpretation of the test requirements and to ensure validation execution can be carried out in a consistent manner. With reference to the specific example described in #1 b, this is to further clarify that a combination of switch and fuse is functionally equivalent to a breaker. As such, it is technically acceptable to check "yes" for circuit breaker in presence of any equivalent electrical circuitry. It will be overly detailed to mention all combinations. The use of the generic terms "circuit breaker" is considered acceptable and do not need further clarification. It is therefore also acceptable to include comments to describe the circuitry in more details as desired by the executor. Premises I Locaux - C A pest control trap location map was not created prior to September However, monthly inspections were performed beginning April This is contrary to step 1.1 of SOP Pest Control, Revision 4. Nonconformance was initiated on As the building was still in projecuconstruction stage, a temporary pest control map was developed in April 2012 while we worked to optimize trap locations. Once the ideal trap locations were determined, a permanent pest control map was developed and approved in September Facilities did not save and file the temporary map from April 2012, as this was considered a working copy. The Pest Control inspection forms were reviewed for the months of April 2012 to September 2012 to confirm that inspections were performed in that period, and that all traps were inspected. Premises I Locaux - C SOP Premises Cleaning, Revision 2 effective had not been implemented by this.site. See combined response for observations 3 & 4 below.

3 Canadian Blood Services Premises I Locaux - C Documentation to demonstrate that all required training had been completed by the contracted cleaning service personnel as required by Appendix A Canadian Blood Services Cleaning Standards and Specifications ( ) was not available. Combined Response - Observations 3 & 4: Nonconformance was initiated on Prior to commencing production and distribution activities, SOP Premises Cleaning, Supplement and Forms 71 F:038 Cleaning Frequency Checklist and 71 F:039 Washroom Checklist were implemented on On , the Facilities staff and the contracted cleaning staff were trained on these documents, including training the Canadian Blood Services Cleaning Standards and Specifications for the contracted cleaning staff. 5. The status of the Compodocks was indicated as "pass" in Table 10-1 of the Equipment Relocation Verification Protocol number However deficiencies were noted. Please note that the protocol in question is numbered Nonconformance was initiated on Table 10-1 should have indicated "Pass with DRF" not "Pass' ~ as there were two deficiencies associated with the Compodocks. A reference to the NCR ( ) was added to the protocol. Combined Response - Observations 5, 11 a-f and 12 a-b: A meeting with all Integrated Equipment Services staff involved in Dartmouth protocol executions was held on , to communicate the requirements of complete and accurate documentation at the time of execution, to include all supporting data, and to create a deficiency when test equipment has failed. Equ ipment I Equipement - C The "slippage check" field was not completed on the Irradiator Maintenance Log dated February This is contrary to SOP Irradiator Maintenance, Revision 7. NCR was initiated during the inspection. The slippage check was repeated on and passed. Follow up was performed with the staff involved on As irradiated products have not yet been produced in the Dartmouth Production and Distribution Site, there was no risk associated with this check not being recorded on the Irradiator Maintenance Log.

4 Canadian Blood Services Monthly generator tests were not conducted at the required frequency. This is contrary to step 2.2 of SOP Generator Operation and Maintenance Revision 2. Nonconformance was initiated on Th e four generators were originally set up and tested in pairs, on alternating months. Th e vendor was consulted to determine th e best method to ensure all generators are tested on a monthly basis. A revised method attesting the generators will be implemented by , fully meeting the requirements of SOP , Generator Operation and Maintenance. 8. During the performance of preventative maintenance of the NDAS probes for refrigerators and freezers, the digital alarm points were not consistently checked for "door ajar". For example, PM for NDA-1028 performed ; NDA-1027 performed ; and NDA performed This is contrary to step 1.9 of SOP Inspection and Preventive Maintenance of the NDAS, Revision 2. The NDAS Maintenance Inspection form for probe NDA -1028, located in stand-alone free zer FRZ-0029, does not have the "door ajar" checked off, as this test is not applicable to this unit. Our review of the NDAS Maintenance Inspection records for NDA and NDA-1027 identified that both probes had multiple form s utilized to record th e results of the Preventive Maintenance activities. Both of these NDAS probes did have th e "door aj ar" checked off on one of the form s, as required, and both had passed the test. Equipment I Eq ui pement - C Equipment history files were not located prior to the performance of equ ipment relocation verification protocol for Compodocks (0006 to ) which was a requ irement of the protocol. No additional actions were taken as part of the NCR to locate these files. During the Inspection, the site was unable to locate Compodock 0006 history file. During the execution of the relocation protocol for the compodocks, the equipment history files were not located. A deficiency was not initiated at that time; therefore, when this was identified an NCR ( ) was initiated on This NCR did not address actions taken to locate the missing equipment history files. During the audit, the history files for COD-0007,. COD-0008, COD-0009, COD-0010 and COD-0011 were located and presented for review; however, the history file for COD-0006 was unable to be located. Nonconformance was initiated on , related to this observation and the missing equipment history file. Ea ch piece of equipment had a new equipment history file created for the Dartmouth facility. A "Note to file" was created and placed in Protocol VAL-RV indicating that the history files were available for COD-0007, COD-0008, COD-0009, COD and COD-0011 for any future reference. Th e file for COD-0006 has still not been located.

5 Canadian Blood Services Equipment I Equipement - C.02.00S 10. The Equipment Relocation Verification Protocol for the Compodocks did not identify the correct original location for each piece of equipment. For example, COD-0007, COD- 0008, COD-0010, and COD-0011 were (sic) indicated to be from London Centre. However these units originated from Hamilton Centre. Nonconformance was initiated on A "Note to file" was added to the protocol including copy of the NCR indicating the correct original locations. Equipment I Equipement - C.02.00S 11. The following issues were identified with IOQ-WRF Version for Walk-in Freezer 0020: a. The serial numbers for the RTD probes were documented incorrectly and did not reflect those used for the qualification. Nonconformance was initiated on During execution of the protocol, a different set of probes were used and the executor did not update the test equipment section of the protocol, as required. The actual RTD probes used were documented in the "prob e placement" description for both empty and loaded temperature mapping. The correct RTD probe documentation has been verified as acceptable and this documentation has been included with NCR , with a copy attached to the protocol. This NCR is also referred to in the test equipment section. b. The testing of the panic button was not performed as directed by the protocol. However the testing was conducted during other areas of the protocol. Nonconformance was initiated on Tab le 12-13, page 32 had been signed off on ; however, the testing of the panic button had been performed on The protocol executor failed to sign off the same day the testing was performed. The NDAS alarm log has confirmed that the panic alarm was tested on A reference to the NCR ( ) was added to the protocol. c. The documentation indicates that ther~ is a dedicated circuit breaker for the unit when in fact the unit does not have a circuit breaker but a combination system consisting of a switch and fuses. Refer to response for Observation 1. d. Table 17-2 Empty Chamber Temperature Mapping documents the use of 15 rather than a minimum of 16 RTD probes for the qualification. It was noted in the comments section at the end of the protocol that RTD probe 107 had failed to function during the qualification. Nonconformance was initiated on There were 16 probes used to

6 Canadian Blood Services perform the temperature mapping; however, one probe (107) failed during the mapping and was discovered at completion. As a result, only 15 probes were documented on Table 17-2 of the protocol, instead of all 16 probes. The acceptance criteria is 80% of the original 16 probes, which equates to 13 or more probes. The missing RTO probe documentation for probe 107 has been included on the NCR which is referenced in the protocol. e. RDN-010 which documents the raw temperature data for the RTDs, does not include the data for probe 107 which failed to function during the mapping process. Nonconformance was initiated on The missing empty chamber data for probe 107 has been included with the NCR which is referenced in the protocol. f. A deficiency was not initiated as a result of the failure to function of RTD probe 107 during the execution of the protocol. Nonconformance was initiated on The protocol criteria is for complete data from 80% of probes, or 13 probes, in this case 15 of 16 probes provided complete data. Currently there is no requirement specified in the protocol to initiate a deficiency for a failed probe when the 80% criteria has been met; however, as indicated in our response to observation 1, the protocol template will be revised by to clarify the requirement as to when to initiate a deficiency. A reference to the NCR ( ) was added to the protocol. g. Post-execution approval was signed off on by the user, facilities and QA even though the above issues were noted in the execution of the protocol. Nonconformance was initiated on The errors discovered in protocol IOQ-WRF during the audit were not detected during final review by Product and Hospital Services, Facilities and QA. Follow up was performed with the reviewers of the protocol on , stressing the importance of thorough and complete review. 12. The following issues were noted with IOQ_WRF Version for the Walk-in Refrigerator RFG-0020: a. On page 43 of 74 of the protocol, a deficiency is documented. However the test status is checked off as "pass" instead of "pass with deficiencies". Nonconformance was initiated on This should have indicated "Pass with deficiencies" not "Pass". A reference to the NCR ( ) was added to the protocol. b. The documentation of the repeat Empty Chamber Temperature Mapping did not include copies of the: i. NDAS temperature graph of qualification ii. Chart recording of testing.

7 Canadian Blood Services Nonconformance was initiated on The chart containing th e remapping data was included in another area of th e protocol, as it was the same chart that was used during th e loaded mapping. The NDA S trend log data was not included, but has since been printed out. This information was required in order to verify th e mapping results, and has now been reviewed and found to be acceptable. The missing documentation has been included with th e NCR ( ) and a reference to the NCR was added to th e protocol. Personnel! Personnel - C The following deficiencies were noted in the Confirmation of Employee Trainings (CETs) for a Biomedical Technologist: a. The CET dated for SOP , was not signed by the employee. It could not be determined whether or not the training was completed. Furthermore, it could not be determined if th is training was requ ired at the time of completion as previous training matrices were not available. Nonconformance was initiated on The employee completed th e required training to SOP , Inspection/Preventive Maintenance of Storage Bottles for Temp. Probes, on By , Corporate Training will add language to the Training Practices Guide Part 1 to require th at historical copies of the matrix are maintained by the local manager or designate, and should be available upon request or as needed. This language will also be included in any future standard operating procedure governing the use of the training matrix. b. The CET dated for SOP , was not signed by the employee. It could not be determined whether or not the training was completed. Furthermore, the "training type" was not completed. It was confirmed during the inspection that this train ing was requ ired at the time. Nonconformance was initiated on The employee completed the required training to SOP , Acceptance, Review and Handling of Local Controlled Documents, on c. The CET dated indicated that training occurred for SOP "Tranferring (sic) Boxed Records to Another CBS Site". The NS Integrated Equ ipment Services Training Matrix identifed (sic) SOP as "Use of On-line National Controlled Documents". It could not be determined wh ich training had actually occurred. Nonconformance was initiated on Our review verified that training was completed for SOP , Transferring Boxed Records to Another CBS Site, which led us to conclude th at th e title was incorrect on the CET for SOP Th e title for SOP is Use of On-line National and Local Controlled Documents. As there was no evidence th at the required training for SOP was completed, th e employee completed the required training to SOP , version 3 on

8 Canadian Blood Services Combined Response - Observation 13 a-c: A meeting with all Integrated Equipment Services staff was held on , to communicate the requirements of completing training documentation correctly. Personnel! Personnel - C.02.00G 14. There is no process in place to consistently document "Read and Sign" training records when training has occurred outside of expected time frames. By , Corporate Training will update the Training Practices Guide Part 1 to require that when change training occurs after implementation date of a new version of a procedure, the reason for this delay is captured in comments on the read & sign tracking form or Confirmation of Employee Training (CET). In addition, Corporate Training will update the Training Practices Guide Part 1 to require that employees not trained by the implementation date of the updated procedure are tracked and are not permitted to perform the activity until trained to the change. Records I Dossiers - C The "Test start time" and "Test end time" fields on the Monthly Generator Test form dated , were not completed for Generator 3 (SN G5A05020). Please note that the observation is actually related to Generator #4 (SN G5A05026), done on Nonconformance was initiated on This was determined to be a documentation omission, as the test was completed, as recorded on the Monthly Generator Test form. The generator had been tested weekly, monthly and annually. A review of the Monthly Generator Test form concluded that the generator was working as expected. Staff responsible for the testing of the generators, and th e review of the Monthly Generator Test form ( ), will be retrained on SOP by If you require clarification or further information, please do not hesitate to contact the undersigned. Please reference the above CBS control number in any correspondence. Sincerely, /) / - /::r.--1 L- ~L.-VJ~T Dr. Christian Choquet ( Vice-President Quality & Regulatory Affairs Fax Number:

Canadian Blood Services Societe canadienne du sang 2013-02-25 CBS Control #: CBS5590 HPFB Fi le #: C1?92-100390 REF: H-1213-BRP

Canadian Blood Services Societe canadienne du sang 2013-02-25 CBS Control #: CBS5590 HPFB Fi le #: C1?92-100390 REF: H-1213-BRP Canadian Blood Services Societe canadienne du sang 2013-02-25 CBS Control #: CBS5590 HPFB Fi le #: C1?92-100390 REF: H-1213-BRP 1800 Alta Vista Ottawa, ON K1 G 4J5 T 613.739.2300 F 613.731.1411 www.blood.ca

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