Transcription
Frederick National Laboratory forCancer Research , Frederick , MDIBIDIDStandard Operating ProcedureBiopharmaceutical Development ProgramTitle: Equipment LogsSOP Number: 21531Revision Number: 09Supersedes: Revision 08Effective Date: JUL 09 ble of Contents1.0Purpose2.0Scope3.0Authority and Responsibility4.0Equipment Which Require Logs5.0Requesting, Compiling, Maintaining and Archiving Equipment Logs6.0Entries to Logs7.0Documentation8.0Definitions9.0References and Related Documents10.0Attachments1.0PurposeThis SOP describes the issuance, use, review, and archiving of equipment logs used at theBOP.2.0ScopeThis SOP applies to the issuance, use, review, and archiving of logs for equipment associatedwith the manufacture, testing, and storage of materials that require a chronological record ofuse, cleaning, and maintenance. This SOP does not apply to Process Analytics/Quality Control(PA\QC) Solution Logs, MMIC Inventory Logs, or to Facility a eaning which are governed byother SOPs.This procedure is made available through federal funds from the National Cancer Institute, NIH, under oontractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY
FNLCR, BDPPage 2 of 18SOP Number: 21531Title: Equipment Logs3.04.0Revision Number: 09Effective Date: JUL 09 2019Authority and Responsibility3.1The Quality Engineering/Validation Manager, Biopharmaceutical Quality Assurance(BQA) has the authority to define this procedure.3.2BQA Documentation (BQAD) is responsible for issuing, tracking, reporting status of, andarchiving completed logs.3.3It is the responsibility of Biopharmaceutical Development Program (BDP) staff to requestequipment logs from BQA, specifying the equipment number and location.3.4Supervisors/Managers are responsible for auditing equipment logs for accuracy andcompleteness. This includes ensuring that maintenance technicians (both FME andoutside vendors) document work in the log according to Sections 6.5 and 8.3 of thisSOP. Supervisors/Managers are also responsible for assuring that they or theirdesignee is familiar with the Preventive Maintenance (PM) schedule and activities andthe equipment calibration due dates.3.5Employees that are responsible for equipment logs or making entries into equipmentlogs must read and understand SOP 21409 - Good Documentation Practices andcomplete the GMP training modules on “Documentation and Recordkeeping” and“Equipment.”3.6BQA Engineering/Validation (or designee) is responsible for periodic review of activelogs and final review of completed logs as indicated in this SOP.3.7BQA is responsible for quality oversight of this procedure.Equipment Which Require Logs4.1Equipment used in or supporting the manufacture, testing, and storage of materials thatrequire a record of traceability shall have a log. Guidance on requirements forequipment logs is given below.4.1.1GLP and CGMP processing or support equipment that requires preventivemaintenance, calibration, or is in product contact requires logs, with thefollowing exceptions: 4.1.24.2Product-contact disposables.Fittings and components including flex lines.Pipettors and pipettes (these are part of the calibration program).Weight sets (these are part of the calibration program).GMP books will receive green back covers to denote the GMP nature of thesebooks.Non-CGMP or R&D Equipment Logs4.2.1Equipment that does not support GLP or CGMP activities are NOT REQUIREDto have associated logs EXCEPT in the cases listed in Section 4.3.4.2.2R&D logs do not require biennial review by BQAE.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 3 of 18SOP Number: 21531Title: Equipment Logs4.2.34.3Revision Number: 09R&D logbooks will receive blue back covers to denote the non-CGMP nature ofthese books.The following equipment has been identified as having high potential impact on productas well as personnel safety. These types of equipment shall have logs regardless ofwhether they support CGMP activities. The logs shall be used to record the informationlisted below, at a minimum.4.3.1Steam Sterilizers (autoclaves including those for waste inactivation) 4.3.24.3.3Date and activity, including cell line/organism(s) processed.Certification activities.Preventive maintenance activities.Cleaning activities, including disinfectant used and, if GMP, disinfectantrelease number.Centrifuges 5.0Date and cycle details (type, duration, sterilization setpoint). For GLP andCGMP validated sterilizers, include load description, cycle code, and cyclenumber.Comments regarding cycle performance (this section is used to documentanything that occurred during a run that was unexpected or “out of theordinary”).Calibration activities.Cleaning and preventive maintenance activities.Validation activities (if applicable) and/or routine checks with biologicalindicators.Biological Safety Cabinets 4.4Effective Date: JUL 09 2019Date and activity, including material/organism(s) processed.Cycle details See SOP 19102 - Routine Use and Disinfection ofBiological Safety Cabinets, Incubators, Shakers, and Centrifuges.Comments regarding cycle performance (this section is used to documentanything that occurred during a run that was unexpected or “out of theordinary”).Calibration activities.Preventive maintenance activities.Cleaning activities, including disinfectant used and disinfectant releasenumber.Methods of maintaining equipment logs not described in this SOP may be acceptablewith approval from BQAE. BQAE will add a note to the front of the log documenting theacceptability of the alternate method.Requesting, Compiling, Maintaining and Archiving Equipment Logs5.1Requesting LogsThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 4 of 18SOP Number: 21531Title: Equipment Logs5.1.15.1.25.2Revision Number: 09Effective Date: JUL 09 2019Employees need to submit a request through theonline request system. Once submitted anautomated email is sent to the BQAD Outlook In Box and a copy is sent to theemployee’s supervisor/manager.5.1.1.1Users will ensure that new logs are obtained from BQA before thecurrent log is completed. Allow 2-4 weeks for processing of requestsfor new logs.5.1.1.2Multiple pieces of identical equipment, such as chromatographycolumns, TFF filter holders, etc., may share an equipment log iflocated near each other. Some logbooks may require the use of twodifferent forms. The format of logs of this type will be individuallytabbed sections for each unique equipment ID. Please make note ofthis in the comments section of the request in Step 5.1.1 above.BQA assigns each requested log a new sequential number from the EquipmentLogbooks database and enters the information provided in the email requestinto the database. The sequential number is derived as follows: “EL” forEquipment Logbook, the Year issued in “YYYY” format, and the four-digitsequential number for the log issued in the given year. Example: EL-20150021.Compiling Logs5.2.1The first page of the equipment logbook is the title page with specificinformation regarding the equipment logbook, e.g.:Biopharmaceutical Development ProgrampH MeterMEF 79040, SOP 12345Equipment Logbook – EL-2015-0021BuildingTechnical Operations - PurificationIssued 03/01/15This is a GMP piece of equipment.Record all use of equipment in this logbook.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 5 of 18SOP Number: 21531Title: Equipment Logs5.2.2Revision Number: 09Effective Date: JUL 09 2019The second page is the QA Review page.BQA Logbook Review HistoryFor Use by BQA (or Designee) OnlyDateReviewedReviewed byNextReview Date5.2.3Pages 3-4 are Form 21531-01 Signature/Initials Log (Attachment 1). This formis placed in the front of all equipment logs. Individuals who document work inthe logs must register their initials and signature on this form the first-time datais recorded in the log.5.2.4The log form content pages are inserted behind the Signature/Initials Log andnumbered sequentially by BQA. The form to be used is indicated on the LogBook Request email.5.2.4.1Several “generic type” log book forms are included in this SOP. Referto attached Forms 21531-04, Date/Time/Activity Log, 21531-05,Date/Time/Temperature/Activity Log, and 21531-06 Chemical FumeHood Log) (Attachments 4-6).5.2.4.2Refer to equipment specific SOPs for specified equipment log forms.5.2.5BQA binds the log and notifies the requestor that the log is ready.5.2.6NOTE: If an SOP is revised that contains a form(s) used in an equipmentlogbook but there are no changes to the form(s) except for theform revision number, the equipment logbook does not need tobe reissued. The SOP database will notify the BQAD email Inbox if there are equipment logbooks that might need to berevised based on a SOP revision. A list of logbooks affected by aSOP revision will be included in the email and BQAD will need toconfirm if a revision is required. Equipment logs generated prior tothe effective date of this SOP that include forms without formnumbers, do not need to be revised until a change is made or the logis archived, and a new logbook is requested.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 6 of 18SOP Number: 21531Title: Equipment Logs5.3Revision Number: 09Maintaining Logs5.3.1The log must be kept near the piece of equipment. This could be on a tablewith the equipment, on a shelf next to the equipment, in a case attached to theequipment, or if appropriate, on the top or side of the equipment. BDPpersonnel, FME technicians, and trained vendors must be able to easily locatethe logbook for entries when using or performing work on the equipment.5.3.1.15.4Effective Date: JUL 09 2019If equipment logs are not located close to the equipment, theequipment shall be labeled to indicate the log’s location.5.3.2Entries are made in the logs as specified by the guidelines in Section 6.0 of thisSOP.5.3.3If the way the equipment is used changes significantly or if its location ischanged, then an entry should be made in the log book explaining the change.5.3.4Periods of equipment inactivity or non-use.5.3.4.1When equipment may not be needed for some time, an entry may bemade in the logbook to indicate that the equipment is “idle”. Thedesignation of idle is not applicable to equipment in constant use suchas CTUs that contain materials or for utilities or other equipment thatis powered on constantly.5.3.4.2Logbooks must be reviewed at their established frequency if theequipment logbook does not have a previous entry of idle.5.3.4.3It is suggested that the logbook be reviewed at the completion of aproduction campaign to reduce the likelihood of exceeding the reviewinterval.5.3.4.4Equipment not in use may be made inactive in the calibration systemper SOP 21508 - Equipment Calibration Program if it is known thatit will not be used for extended periods. This status should also berecorded in the logbook.5.3.4.5A reviewer may also indicate during their review entry that theequipment is idle.Reviewing Logs5.4.1Each Manufacturing and Utility log is reviewed monthly at a minimum.5.4.2Each Development and Process Analytics\Quality Control log is reviewed everythree months at a minimum.5.4.3Pages are reviewed by the Supervisor/Manager or designee who has beentrained on SOP 21409 - Good Documentation Practices.5.4.3.1Supervisors/Managers or designees may indicate their review on thenext available entry line on an incomplete page. The review does notneed to wait until the time the page is complete and be documented atthe end of the page.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 7 of 18SOP Number: 21531Title: Equipment Logs5.4.4Revision Number: 09Effective Date: JUL 09 20195.4.3.2Reviewers should avoid reviewing their own entries.5.4.3.3If no activity has occurred since the most recent review, a new reviewis not necessary under two conditions5.4.3.3.1There is an entry from the user or reviewer in the logbookexplaining the reason for inactivity.5.4.3.3.2The equipment is “idle”.5.4.3.4Routine review of the logbook resumes when activity has beenreestablished (such as use in a process rs should use calibration due notifications and be familiar withPM intervals to avoid missing review of PM or calibration entriesduring idle periods.5.4.3.6During idle periods for the equipment, Supervisor/Manager reviews ofPM or calibration activities will occur not more than three months fromthe date work was performed.GLP and CGMP Logbooks are scheduled for review by BiopharmaceuticalQuality Assurance Engineering (BQAE) or their designee at two-year intervals;based on the issue date for the first review and then the review date forsubsequent reviews. The logs due for revision are posted in a spreadsheetlocated atThis log is created andupdated from a database.5.4.4.1Logs that are not in routine use may be returned to BQA so that BQAcan route the logbook to BQAE for this review. If for some reason thelog may not be removed from the in-use location, the BQAErepresentative will perform an on-site review of the logbook.5.4.4.2During their review, BQAE will monitor compliance to SOP 21409 Good Documentation Practices, the operational and maintenanceSOPs for the equipment, and this SOP. After this periodic review, thelog may be archived by BQA, or may be returned to the owner forfurther use. Specific items to look for are included in the followingtable. This list is not meant to be inclusive.Accuracy of entriesAll names in log onsignature page.Reviews performed atspecified intervalProper use of errorand correction codes.Consistency ofentriesCalibration recordedat specified interval.Periods of inactivitydocumented per5.3.3.5Key usage events arerecorded.Legibility of entriesPM recorded atspecified intervalWork Order (WO)numbers recordedwhere applicableOutside vendor activityrecorded by eithervendor or user.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 8 of 18SOP Number: 21531Title: Equipment Logs5.55.6Effective Date: JUL 09 20195.4.4.3The review and any relevant corrections will be documented on Form21531-02, BQAE Logbook Review Findings. The signed completedform will go to BQAD for filing in the MEF for the equipment.5.4.4.4Once BQAE completes the review of a logbook, they will sign theBQA Logbook Review History on the second page of the logbook byentering the Date Reviewed, their signature, and the Next ReviewDate (two years from the recorded “Date Reviewed”). BQAE ordesignee will also update the spreadsheet with the next review date.5.4.4.5A follow up review may be performed to verify if remedial measureshave been taken prior to the next scheduled BQAE review. If a followup review is performed, it is recommended to perform such a reviewwithin three months of the initial review.Completed logs and logs that are no longer needed are returned to BQA for review byBQAE or designee before being archived using Form 21531-03, Equipment LogbookReturn.5.5.1BQAE reviews the logbook and works with logbook owners and managementto resolve any issues identified during their review.5.5.2For partial logs to be retired, BQAE verifies the presence of or makes an entryafter the last entry stating, “No other entries will be made in this logbook” or anequivalent statement that is initialed and dated.5.5.3BQAE signs the review history table on the second sheet of the logbook,indicates the log is ready for archival, and returns the logbook to BQA to bearchived.Archival5.6.16.0Revision Number: 09BQA enters the log information, including archival date (return date), into itsequipment log database system. The log is then archived according to SOP21402 - Document Storage and Archival Process.Entries to Logs6.1Entries to logs are made according to SOP 21409 - Good Documentation Practices.Entries are made in chronological order.6.2Date and time are entered in logs for each entry. The MMDDYY date format (i.e.,091401 for September 14, 2001) and Military/24-hour standard with no colon time format(i.e., 1310 for 1:10pm) are preferred.6.3At a minimum, as a default requirement, log entries will include a description of cleaning,maintenance, use, and other events. Each entry will include the date and time, productand lot number (as applicable), and the initials of the person performing the event.6.4The operation and maintenance SOPs for the equipment provide specific guidance onthe entries that should be made.This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 9 of 18SOP Number: 21531Title: Equipment LogsRevision Number: 096.5Logs are used in addition to other mechanisms for documenting events, such as SOPs,the area clearance system, and Batch Production Records (BPRs). Making entries tologs does not eliminate the need for recording events using other establishedprocedures. Rather, entries to logs provide a chronological record of initiation,calibration, maintenance, use, and cleaning as well as the support information used tocomplete the documentation associated with those other systems.6.6Log Entries for Maintenance Work6.6.1Routine maintenance work, including calibration, may be recorded as a genericdescription of the work, with task number associated (if applicable), the date,time, and technician’s initials. If a work order was associated with the work,that number is referenced.6.6.1.16.6.27.08.0Effective Date: JUL 09 2019If the work takes more than one day to complete, at least two entriesshould be made. The first entry will indicate the start of the task andthe second would indicate when the task is completed.Non-routine maintenance work (such because of failure or engineering change)will include details of the activity, such as a description of the failure/change,the reason for the event (if known), any identification numbers of partsaffected/replaced, and the date, time, and technician’s initials. TheEngineering Event (failure or change), work order, or trouble call numberassociated with the work is referenced. See SOP 21526 - Engineering EventManagement.6.6.2.1For work performed by outside contractors, BDP staff must ensurethat the contractor makes the necessary entries or BDP staff maymake the entries on behalf of the contractor using information fromthe service ticket or verbal communications.6.6.2.2BDP staff should verify if FME has made needed entries to theequipment log (for calibration, repairs, and scheduled PM). If entriesare missing or have any errors, BDP staff may make any neededentry and should notify BQAE of any deficiency.6.6.2.3For any alteration or reload of software required for testing of theequipment, the log entry will include the description of the software,control number, and edition date (if applicable), the alteration that wasmade, why the alteration or reload occurred, and the “as-left” status.Documentation7.1Logbooks are kept by BQA for a minimum of ten years. Completed or retired logbooksmay be sent to off-site storage for archiving according to SOP 21402 - DocumentStorage and Archival Process7.2Form 21531-02, BQAE Logbook Review Findings shall be kept by BQA or at the off-sitestorage contractor for a minimum of ten years.DefinitionsThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 10 of 18SOP Number: 21531Title: Equipment LogsEffective Date: JUL 09 20198.1BDP Equipment Number – The BDP MEF number or, if one does not exist, the NIHnumber.8.2Campaign Equipment – Equipment that is used only for project specific operationsduring production activities. Such equipment may go for months or years betweenperiods of usage.8.3CTUs – Controlled Temperature Units.8.4Equipment Type – The manufacturer’s description or suggested use for the equipmentin question, such as “freezer,” “autoclave,” etc. If the log is being used for an equipmentsystem, such as a utility system, that description may be considered the equipment type(i.e., “ Compressed Air System”).8.5Form Number – When the logbook is to be made up of forms bound together, the formused is listed under “Form Number.”8.5.19.0Revision Number: 09Occasionally a form that is in current use in an equipment log will be revised aspart of an SOP revision. BQA will notify users if an equipment log needs to bereturned because of a revision to an SOP.8.6Idle – A period when equipment is not actively in use. The only potential activities forthe equipment during such a period are preventive maintenance and calibration.8.7Location – The building and room where the log will be used or stored when not in usefor portable equipment.8.8Review Due Date – The date that the equipment log is due to be returned to BQA forperiodic review, if the log is not filled before this date. This date is set two years from theissue date or the date of last review. After this periodic review, the equipment log maybe archived by BQA, or may be returned to the owner for further use.References and Related Documents9.1SOP 19102Routine Use and Disinfection of Biological Safety Cabinets,Incubators, Shakers, and Centrifuges9.2SOP 21402Document Storage and Archival Process9.3SOP 21409Good Documentation Practices9.4SOP 21508Equipment Calibration Program9.5SOP 21526Engineering Event Management9.621 CFR 211.67Equipment Cleaning and Maintenancea) Equipment and utensils shall be cleaned, maintained, and, as appropriate for thenature of the drug, sanitized and/or sterilized at appropriate intervals to preventmalfunctions or contamination that would alter the safety, identity, strength, quality,or purity of the drug product beyond the official or other established requirements.b) Written procedures shall be established and followed for cleaning and maintenanceof equipment, including utensils, used in the manufacture, processing, packing, orholding of a drug product .This procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPPage 11 of 18SOP Number: 21531Title: Equipment LogsRevision Number: 09Effective Date: JUL 09 2019c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection asspecified in §211.180 and §211.182.9.721 CFR 211.68 Automatic, Mechanical, and Electronic Equipmenta) Automatic, mechanical, or electronic equipment or other types of equipment,including computers, or related systems that will perform a function satisfactorily,may be used in the manufacture, processing, packing, and holding of a drug product.If such equipment is so used, it shall be routinely calibrated, inspected, or checkedaccording to a written program designed to assure proper performance. Writtenrecords of those calibration checks and inspections shall be maintained.b) Appropriate controls shall be exercised over computer or related systems . In suchinstances a written record of the program shall be maintained along with appropriatevalidation data 9.821 CFR 211.182 Equipment Cleaning and Use LogA written record of major equipment cleaning, maintenance . and use shall be includedin individual equipment logs that show the date, time, product, and lot number of eachbatch processed . The persons performing and double-checking the cleaning andmaintenance shall date and sign or initial the log indicating that the work wasperformed. Entries in the log shall be in chronological order.9.910.0NCI-Frederick Environment, Health, and Safety (EHS) Safetygrams9.9.1ISM-125: “Laboratory Personnel: Steam Sterilization,” August 2013.9.9.2ISM-144: “Laboratory Personnel: Effective Use of Biological Safety Cabinets(BSC’s),” August 2013.9.9.3ISM-200: “General: Centrifuge Rotor Safety,” March 2013.Attachments10.1Attachment 1Form 21531-01, Signature/Initials Log10.2Attachment 2Form 21531-02, BQAE Logbook Review Findings10.3Attachment 3Form 21531-03, Equipment Logbook Return10.4Attachment 4Form 21531-04, Date/Time/Activity Log10.5Attachment 5Form 21531-05, Date/Time/Temperature/Activity Log10.6Attachment 6Form 21531-06, Chemical Fume Hood Log10.7Attachment 7Form 21531-07, Water Sampling Observation LogThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPSOP Number: 21531Title: Equipment LogsPage 12 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 1Form 21531-01, Signature/Initials LogThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPSOP Number: 21531Title: Equipment LogsPage 13 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 2 (Page 1 of 2)Form 21531-02, BQAE Logbook Review FindingsThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BDPSOP Number: 21531Title: Equipment LogsPage 14 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 3Form 21531-03, Equipment Logbook ReturnThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
FNLCR, BOPSOP Number: 21531Title: Equipment LogsPage 15 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 4Form 21531-04, Date/Time/ActivityLogFNLCR,BDPFo011 No.: 21531-04SOP No · 2153 1Rev,s,on09: JUL09 2019Biopharmaceutical Development ProgramEL XXXX XXXX, MEF #XXXXXEqupi ment NameBuilding. Room XXXXX0DateTime0Activity / CommentsPaae 3 of 25InitialsNOTE: Peli ormance of PM or FM E work order shall be noted in this logbook, with descnpllon of work, PlvVFM E Work Number and Retum ofEquipment to Service. Enter Day, Date, and Time of completions, what was done to equipment, and initials of technical who works onequipment (See SOP 21531, Equipment Logs).Reviewed By/Date:s procedure is made available through federal funds from the National CancerInstitute, NIH, under contractihTUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY
Page 16 of 18FNLCR, BOPSOP Number: 21531Title: Equipment LogsRevision Number: 09Effective Date: JUL 09 2019Attachment 5Form 21531-05, Date/Time/Temperature/Activity LogFNLCR. BOPF oon No.: 2 1531-05SOP No c 2 1531RPI/ision Oil: JUL og20I QDateBi op ha rm a ceut ic al De velop m ent P rog ra mE L -X:XXX -XXXX, MEF #XXX:XXEqupi ment NameBuildingRoom XXXXXTimeTemp{ C )Page 3 of 25Activity/CommentsNOTE: Performanceof PMor FMEwork order shall be noted1n this logbook, w,th descnpt10n of 'M rk, PM/FME Work Number andtto Service. Enter Day, Date, and Time of compleitons, what was done to equipment, and initialsofReturn of Equipmenttechnical who works onequipment (See SOP 21531, EquipmentLogs).Reviewed By/Date:Thisprocedure is made available throughfederal funds from the National CancerInstitute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLYInitials
FNLCR, BOPSOP Number: 21531Title: Equipment LogsPage 17 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 6Form 21531-06, Chemical Fume Hood LogFNLCR, BOPForm No.: 21531-06SOP No.: 21531Revision 09: JUL 09 2019DateBiopharmaceutical Development ProgramEL-XXXX-XXXX MEF #XXXX-XXX-XChemical Fume Hood LogBuilding Room XXXXXDescription of UseProduct/Lot #(If Applicable)Pa ge 3 of 50Recorde d by/DateRev ie w e d By /Da te :procedure is made available through federal funds from the National Cancer Institute, NIH, under contracthUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY
FNLCR, BDPSOP Number: 21531Title: Equipment LogsPage 18 of 18Revision Number: 09Effective Date: JUL 09 2019Attachment 7Form 21531-07, Water Sampling Observation LogThis procedure is made available through federal funds from the National Cancer Institute, NIH, under contractUNCONTROLLED COPY FOR TRAINING AND REFERENCE PURPOSES ONLY.
automated email is sent to the BQAD Outlook In Box and a copy is sent to the employee's supervisor/manager. 5.1.1.1 Users will ensure that new logs are obtained from BQA before the current log is completed. Allow 2-4 weeks for processing of requests for new logs. 5.1.1.2 Multiple pieces of identical equipment, such as chromatography
