hvac qualification

PROTOCOLHVAC Installation Qualification Protocol | IVTByMiguel MontalvoApr 23, 2013 2:16 pm PDTProtocol No.

Effective Date

Revision #1

Installation Qualification ProtocolTitle: HVACCompany XAPPROVAL PAGESystemHVAC

LocationCompany X, Inc., Address

Protocol Prepared By:

Name/TitleSignatureDate

Protocol Reviewed By:


Protocol Technical Reviewed By:


Protocol Approved By:


Table Of Contents1.0SYSTEM OVERVIEW2.0SYSTEM BOUNDARY3.0OBJECTIVE4.0SCOPE5.0QUALIFICATION STUDY OVERVIEW6.0RESPONSIBILITY7.0PREREQUSITES8.0ACRONYMS9.0DEFINITIONS10.0GENERAL DOCUMENTATION REQUIREMENTS11.0DATA COLLECTION AND DOCUMENTATION PROCEDURES12.0INSTALLATION QUALIFICATION TEST REQUIREMENTS13.0REFERENCESIndex Of AttachmentsATTACHMENT 1Personnel Identification ListATTACHMENT 2Test Equipment Identification/CalibrationATTACHMENT 3 Test Equipment OperationATTACHMENT 4Equipment / Component VerificationATTACHMENT 5Utilities VerificationATTACHMENT 6Support Documentation - Equipment/System SpecificationsATTACHMENT 7Support Documentation - SubmittalsATTACHMENT 8Support Documentation Purchase OrdersATTACHMENT 9Support Documentation Equipment ManualsATTACHMENT 10Support Documentation - Equipment/System DrawingsATTACHMENT 11Support Documentation - Equipment/System Standard Operating ProceduresATTACHMENT 12Support Documentation - Equipment/System Calibration ProceduresATTACHMENT 13 Support Documentation - Equipment/System Calibration ProgramATTACHMENT 14Maintenance - Spare Parts ListATTACHMENT 15Maintenance - Lubricant Verification1.0 SYSTEM OVERVIEWHistoryThe AHU-6 and MAU-1 HVAC system includes Air Handling Unit (AHU-6) and Make Up Air Unit (MAU-1). AHU-6 was purchased from York International in October 1994. AHU-6 was designed and installed to supply recirculating air to rooms: 123125. MAU-1 was purchased as part of the building and operated to supply make up air to the AHU-6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors. DescriptionThe major equipment / components of the AHU-6 and MAU-1 HVAC system include Air Handler Unit AHU-6, Make Up Air Unit MAU-1, Humidifier H-1, twelve (12) reheat coils RHC-1-RHC-9 and RHC-19 RHC-21 and fourteen (14) exhaust fans EF-1 - EF-12, and EF-15 - EF-17.AHU6 is a recirculating air handling unit, which provides a constant volume of airflow to rooms 123,124, and 125. It is equipped with a Pre Cooling coil, Preheat coil and 65% efficiency air filters. AHU-6 provides airflow using outside air from MAU-1 mixed with return air.MAU-1 provides conditioned air to rooms 111, 113, 114, 117, 118, and 120-125 utilizing 100% outside air. It is equipped with one (1) reheat coil and two (2) cooling coils. It has 35% efficiency pre-filters and 95% efficiency bag filters, it also utilizes eleven (11) Variable Air Volume controllers VAV-A, B, C, D, E, F, G, H and VAV-j, K and L. one (1) Steam Humidifier H-1 located in the supply air duct downstream from MAU-1 provides humidificationThe system is designed to provide personnel comfort. Performance criteria for the system are:Temperature:70F 5FHumidity:20-80% R.H.RationaleThis protocol will be performed utilizing 21 CFR 210 & 211, ICH Q-7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001,.Upon final approval of this IQ Protocol and Summary Report it will replace the previous IQ study and render it obsolete. The system will also be placed under formal change control in accordance with Company XChange Control Program summarized in Standard Operating Procedure DNAP/QM/012 entitled Change Control System.2.0SYSTEM BOUNDARYThe system boundary is defined as the supply utility service first point of contact with the system/equipment being installation qualified. In most cases this is interpreted as the first inlet manual valve or motor control/electrical panel providing supply of said utility.Supplied UtilitiesID NumberDescription

Compressed Instrument AirInlet at respective valveSupply air to all applicable pneumatic valves on the AHU-6

Compressed Instrument AirInlet at respective valveSupply air to all applicable pneumatic valves on the MAU-1.

Low Pressure SteamInlet at respective valveSupply to appropriate inlets of H-1

Compressed Instrument AirInlet at respective valveSupply air to all applicable pneumatic valves on all VAV boxes: 1-9,19-21.

Chilled Water In-AHU-6CHWS-18Supply to Cooling Coil-

Chilled Water Out-AHU-6CHWR-19Return from Cooling Coil

Hot Water In-AHU-6HWS-2Supply to hot water coil-

Hot Water Out-AHU-6HWR-2Return from hot water coil

Low Pressure Steam Out-MAU-1To Be Field VerifiedReturn from steam reheat coil

Low Pressure Steam In-MAU-1To Be Field VerifiedSupply to steam reheat coil-

Chilled Water Out-MAU-1To Be Field VerifiedReturn from cooling coil

Hot Water In-RHC-1To Be Field VerifiedSupply to hot water coil

Hot Water Out-RHC-1To Be Field VerifiedReturn from hot water coil























Chiller-1To Be Field VerifiedOutlet to respective Valve



Hot Water Boilers (7)To Be Field VerifiedOutlet to respective Valves

Low pressure Steam Boilers (10)To Be Field VerifiedOutlet to respective Valves

ElectricalAHU-6Main Breaker Supply to Unit

ElectricalMAU-1Main Breaker Supply to Unit

3.0 OBJECTIVEThe intent of this Installation Qualification (IQ) is to provide a complete inventory of major equipment and/or components installed on the HVAC AHU-6 and MAU-1 system and to ensure that: Major components are those as specified in system manuals, contractors submittals, original purchase orders or approved equivalents. These major components will be verified during execution of this protocol. All critical instruments are calibrated and placed within the calibration program as defined in MF/SOP/178. Operation manuals for the system or equipment are identified and available. Required spare parts are identified System or equipment maintenance requirements are clearly defined and documented and are placed in the Preventative Maintenance Program as defined in MF/SOP/179. System or equipment cleaning procedures are established and current. Lubricants will be identified and evaluated for acceptability during execution of this protocol. As-built drawings reflect the actual installation of the system or equipment installed on (HVAC AHU-6 and MAU-1 system).4.0SCOPEThis protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X, Inc., Address5.0QUALIFICATION STUDY OVERVIEWDuring the execution of this protocol, determination of the calibration frequencies and formalized procedures will be provided to AAC Consulting Group, Inc. (AAC) by Company X, Inc. Company X will calibrate all instrumentation requiring calibration with traceability to NIST and certificates of calibration provided to AAC for inclusion in the applicable section of this protocol.The operation of AHU-6 and MAU-1 are controlled by Johnson Controls Metasys Air Handling Unit Controllers with sensors monitoring air/water temperature, humidity and air/water pressure. The operation is monitored through the use of the Metacomm system as a Building Management System (BMS). Metasys VAV Controllers are provided for the control of each VAV box. The BMS control system will be qualified in a separate protocol, as part of the Computer System Validation (CSV).The Operational Qualifcation of this system will be performed in accordance with protocol # MF/VAL/OQ/013/PRO entitled Operational Qualification of HVAC AHU-6 and MAU-1 System.6.0RESPONSIBILITY6.1Validation Department:6.1.1Prepare and submit the protocol for approval in accordance with current industry standards, regulatory requirements, and approved Standard Operating Procedures.6.1.2Perform and coordinate the execution of the protocol and recording of all raw data.6.1.3Review deviations and support the preparation of all corrective action reports that may be required to resolve discrepant situations.6.1.4Prepare and/or coordinate the preparation of a final test report analyzing and summarizing the data and submit for review and approval.6.2AAC Consulting Group:6.2.1Provide technical input into the preparation of the test protocol in accordance with cGMPs, industry, USFDA standards and guidelines, and Company Xapproved Standard Operating Procedures. Provide expert review of the finished protocol and procedures.6.2.2Assist in the performance of the execution of the test protocol and recording/analysis of the test results.6.2.3Assist in the preparation of deviation reports and recommend corrective actions to resolve discrepant situations that may arise during execution of the test protocol.6.2.4Assist in the preparation of a final report and provide input as to the conclusions summarizing the study and submit to Company Xmanagement for review and approval.6.3Manufacturing:6.3.1Review and approve the test protocol.6.3.2Provide qualified personnel to assist with the execution of the protocol and the collection of samples.6.3.3Assist in preparation of deviation reports and recommend corrective action to resolve discrepant situations that may arise during execution of the protocol.6.3.4Review and approve the final report.6.4Engineering and/or Facilities Department:6.4.1Review and approve the test protocol.6.4.2Provide documentation required for the generation and execution of the protocol.6.4.3Provide equipment that has been commissioned and functional as specified by Site Acceptance Test Report.6.4.4Provide assistance in evaluating and resolving equipment malfunctions that may be encountered during execution of the protocol.6.5Quality Assurance:6.5.1Review and approve the test protocol in accordance with the approved SOPs, cGMPs, and current industry guidelines.6.5.2Review deviations and support preparation of corrective action reports that may be required to resolve discrepant situations.6.5.3Review and approve the final report.7.0PREREQUSITESAll Standard Operating Procedures required for the execution of this IQ such as maintenance and calibration of the equipment undergoing IQ must be approved before the IQ Final Report can be approved.8.0 ACRONYMSAHUAir Handling Unit

ALAirlock

CGMPcurrent Good Manufacturing Practice

CPHChanges per hour

CAVControl Air Volume Boxes

EWTEntering Water Temperature

GPMGallons Per Minute

HEPAHigh Efficiency Particulate Air

HVACHeating, Ventilating, and Air Conditioning

IWGInches of Water Gage

LATLeaving Air Temperature

LWTLeaving Water Temperature

MAUMake-Up Air Unit

NEBBNational Environmental Balancing Bureau

NLTNot Less Than

NMTNot More Than

IQInstallation Qualification

PSIPound per Square Inch

PMPreventive Maintenance

P&IDPiping and Instrumentation Diagram

RPMRevolutions Per Minute

SOPsStandard operating Procedures

RHCRe Heat Coils

TABTesting, Adjusting, and Balancing

VAVVariable Air Volume (Dampers or Boxes)

5.0DEFINITIONSAcceptance CriteriaThe system specifications and accept/reject criteria that are necessary for making a decision to accept or reject the system and/or component being qualified.Summary of ResultsA written summary of the qualification policies, procedures, and results that may include graphs and tables to support conclusions and final acceptance. Also included in this summary would be documentation of deviations, their investigation, and final corrective action implemented to provide final closure.SystemThe term system as used in this protocol refers to the series of components, measuring or control devices and/or equipment, that when working together perform a function considered critical to the manufacturing of a product intended for medicinal use. Within the scope of this procedure, the term system equally applies to computerized systems, process control systems, utilities, services, and equipment set-ups (e.g., a reactor-condenser-motor-agitator set-up).10.0 GENERAL DOCUMENTATION REQUIREMENTS10.1Personnel Identification List10.1.1All personnel involved in the execution of the protocol must review and complete Attachment 1.10.1.2Curriculum Vitae for all contract personnel have been submitted to the Validation Department, documented in the Approved Personnel List maintained by the Document Control Department at Company X, Inc.10.2Test Equipment Identification/Calibration10.2.1Document on Attachment 2 the test equipment that is used during execution of this protocol.10.2.2All test equipment descriptions have been submitted to the Validation Department, documented in the approved Test Instrument List maintained by the Document Control Department at Company X, Inc.10.2.3All test equipment must be calibrated against standards that are NIST traceable. Copies of all calibration certificates for the test equipment must be included in this attachment.10.3Test Equipment Operation10.3.1Document on Attachment 3 the SOPs and/or Operation Manuals that are required for the test equipment used in the execution of this protocol.10.4Protocol Corrections10.4.1Protocol corrections must be documented by the issuance of a protocol amendment providing the correct information.10.5Raw Data Corrections10.5.1Corrections to the raw data must be performed using a single line cross out and explanation with the persons initials and date.10.6Protocol Deviations10.6.1A protocol deviation indicates the discovery of discrepant results, methods, information, or procedures resulting from the execution of this protocol.10.6.2A discrepancy indicates the discovery of discrepant results.10.6.3All protocol deviations, discrepancies, and incidents must be documented in accordance with the current Company X Standard Operating Procedure # MF/SOP/097, entitled SOP for the Reporting and Investigation of Investigation on Incidents, Discrepancies and Deviations.10.7Worksheets10.7.1Data, other than laboratory data, must be documented on one of the following types of worksheets during the execution of the protocol:10.7.2Protocol specific data worksheets, provided in the attachments, are to be used to record data as required.10.7.3The General Data Worksheet provided in the attachments, may be customized for additional data collection or clarification.10.7.4Copies of raw data from notebook pages or laboratory test results may be attached to this summary package.11.DATA COLLECTION AND DOCUMENTATION PROCEDURES11.1Installation Qualification Worksheets11.1.1Each IQ worksheet must be completed as directed on the individual worksheet.11.1.2The executed IQ worksheet raw data should be compared against the acceptance criteria, evaluated, and initialed/dated. In the event the acceptance criteria are not met, a deviation report must be prepared, reviewed and approved, and recorded on the deviation report log for each occurrence.11.1.3All data and results are to be recorded on approved copies of IQ worksheets.11.1.4Initial and date each entry and sign and date each worksheet.11.1.5Each page of any attachments to the protocol must reference the protocol #, section and page #, and must be initialed and dated.11.1.6A summary of results reflecting conclusions for all verifications should be prepared and this document inserted at the beginning of the data package.11.1.7The acceptance criteria as indicated for each IQ worksheet must be met.11.1.8 All specified data available at the time of protocol generation should be entered on each worksheet prior to approval of the protocol. The source of each specified value entered should be referenced in the comment section of each IQ worksheet. All specified data that cannot be determined at the time of protocol generation will be recorded as Not specified and the actual value from field verification will be recorded. In the event a specified cannot be field verified a reason should be entered in the comment section of the form.12.INSTALLATION QUALIFICATION TEST REQUIREMENTS12.1Objective11.1.1To verify that the HVAC system and its components have been installed in accordance with the requirements as indicated in the engineering specifications and system drawings.12.2Acceptance Criteria11.2.1The acceptance criteria as indicated on each protocol attachment must be met or written explanation providing resolution must be documented.12.3Procedure12.3.1Complete each protocol attachment as directed on the individual attachment making sure all required data is properly recorded, initialed, and dated.12.4Methods of Data Analysis12.4.1Review all completed attachments and compare against the acceptance criteria to assure that all criteria have been met.13.REFERENCES13.1ISO-14644-1, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness, First Edition, 1999-05-01.13.2ISO-14644-2, Cleanrooms and Associated Controlled Environments, Part 2: Specifications for Testing and Monitoring to Prove Compliance with ISO 14644-1, First Edition, 2000-09-15.13.3ISO-14644-4, Cleanrooms and Associated Controlled Environments, Part 4: Design, Construction, and Start-up , First Edition, 2000-04-01.13.4ISO-14644-7, Cleanrooms and Associated Controlled Environments, Part 7: Separative Enclosures (Clean Air Hoods, Gloveboxes, Isolators, Mini-Environments, Draft.13.5Title 21, Code of Federal Regulations, Parts 210 and 21113.6ICH, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001.13.7Standard Operating Procedures for Reporting and Investigation of Deviations, Metrology Services, Preventive Maintenance, Change Control System.General Data WorksheetAttachment #__Use this worksheet for additional data gathering or data clarification. Include in applicable section of summary package.NOTE: Make copies of this worksheet as necessary.

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ATTACHMENT #1 Personnel Identification ListEach person who will be executing the protocol must complete an entry on this page. Signatures signify that they have been trained in the protocol and understand the protocol requirements.NOTE: Make copies of this attachment as necessary.NameTitleSignaturesInitialsDate

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ATTACHMENT 2Test Equipment Identification/CalibrationDocument test equipment not installed on the equipment/system being qualified that are required for execution of this protocol.NOTE: Make copies of this attachment as necessary.Test Equipment Calibration

DescriptionModel #Serial #Tag #Last Cal DateCal Due DateInitialsDate

Acceptance CriteriaCriteria Met?(Yes/No/NA)InitialsDate

The test equipment is calibrated and the calibration is current.

The calibration standards are traceable to NIST.

A copy of the calibration certification(s) for the test equipment used is attached.

Comments:

Completed by:Date:

Reviewed by:Date:

QA Approval:Date:

ATTACHMENT 3 Test Equipment OperationDocument SOPs and/or Operation Manuals that are required for operation of the test equipment used in the execution of this protocol and verify they are current.NOTE: Make copies of this attachment as necessary.Document #TitleEffective DateCurrent and Documented?(Yes/No)Initial/Date

Completed by:Date:

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ATTACHMENT 4Equipment / Component Verification(one per each main component including instrumentation/Controls)DescriptionAIR HANDLING UNIT AHU-6

Specified1ActualInitial/Date

TypeA-Series

LocationMezzanine above Room 124

ID #AHU-6

ManufacturerYork International

Model #AP80FSFCV12X12

Serial #CADM-005952

Capacity Rating3400 CFM

Dimensions (L*W*H)126x 53x 43

Acceptance CriteriaCriteria Met?(Yes/No/NA)Initial/Date

Actual values conform to specified values.

Justifications are provided for actual values that cannot be field verified.

Comments1Specified values taken from Dwg # H-04-rev 2, PO # 30563-05, York International I/O/M Manual, 100.09-nom1.

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ATTACHMENT 5Utilities VerificationDocument Hot Water requirements for the applicable equipment/system undergoing IQ. Also document specific connections to the facility steam supply. List sources for any specified information recorded on this page in comments. All information recorded as actual is from field verification unless recorded as otherwise in comments. NOTE: Actual information, such as pressure, should be measured where possible.Description / PurposeType ( X ) Plant ( ) Clean

ItemSpecified1ActualInitial/Date

SourceBoiler (7) HydroTherm-MultiTemp

Regulated Pressure18 PSI

Temp173 F

Method of JoiningTo be field verified


Actual values conform to specified values.

Justifications are provided for actual values that cannot be field verified.

Dielectric Unions are present between piping of dissimilar metals.

Comments

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ATTACHMENT 6Support Documentation - Equipment/System SpecificationsDocument associated equipment/system specifications including, manufacturing specifications, vendor audits, Factory Acceptance Testing, and inspection reports for the equipment/system undergoing IQ. Also, document the equipment/system logbook established for the equipment/system undergoing IQ.NOTE: Make copies of this attachment as necessary.NOTE:For computer related systems, document associated specifications including computer system validation plan, process description (user requirements), functional requirements, design specification, software description and change control history.TypeTitle/DescriptionDoc. #LocationInitial/Date


Copies of the manufacturing specifications for the equipment/system are attached.

Installed conditions have been verified to reflect functional specifications.

Equipment/system logbook established.

Filter specifications and manufacturing validation guides are available.

HEPA filter specifications are available.

Computer related systems have specifications available.

Comments

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ATTACHMENT 7Support Documentation - SubmittalsList the approved submittals as supplied by the contractor or manufacturer supporting the system and system components. Include a copy of each submittal with this protocol.Description:InitialsDate


The submittals have been verified to accurately describe and document the system being qualified.

Copies of the approved submittals for the system and components are attached.

Comments

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ATTACHMENT 8Support Documentation - Purchase OrdersList the purchase orders supporting the system and system components. Include a copy of each purchase order with this protocol.DescriptionPurchase Order NumberInitialsDate

Air Handler AHU-630563-05

Variable Air Volume Box30563-12

Heating/Cooling Coils30563-05

Exhaust Fans30563-12

Humidifier H-130563-07


The system being qualified conforms to the PO requirements.

Copies of the purchase orders for the system and system components are attached.

Comments

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QA Approval:Date:

ATTACHMENT 9 Support Documentation - Equipment ManualsVerify that pertinent equipment documentation exists and reference the location where the document is kept.TitleLocationInitials/Date

Acceptance CriteriaCriteria Met?(Yes/No/NA)Initials/Date

The manufacturers equipment manuals are described above and the location of each manual is documented.

Comments

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ATTACHMENT 10Support Documentation - Equipment/System DrawingsDocument associated process flow drawings, P&IDs, layout drawings, shop drawings, and any other pertinent drawings, including all associated equipment, facility, and utility drawings for the equipment/system undergoing IQ. Verify that the drawings are accurate and sufficient to characterize the equipment/system. Verify that components are physically labeled in accordance with drawings. Highlight the verified portions of the drawings and redline changes as necessary. All drawings must be verified, signed, and dated. Submit any redlined drawings to the Document Control Group for revision. Include copies of the highlighted, verified drawings, redlined copies, and applicable Document Control Forms with this summary package.NOTE: Make copies of this attachment as necessary.NOTE: Controller diagrams and wiring diagrams will be documented on separate attachments.Drawing #TitleRev.Rev. DateInitial/Date


Drawing list includes associated equipment, facility, and utility drawings.

Drawings, with redlines if applicable, are sufficient to characterize equipment/system.

Equipment/system installation corresponds to drawings, with redlines if applicable.

Components including equipment, valves, and instruments are physically labeled and labels correspond to drawings, with redlines if applicable.

Copies of verified drawings and redline copies are included with this summary package.

Drawings have been verified, signed, and dated.

Redlined drawings submitted for revision to the Document Control Group and copy of Document Control form included with this summary package.

The Document Control Group controls original drawing files.

Comments

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Reviewed by:Date:

QA Approval:Date:

ATTACHMENT 11Support Documentation - Equipment/System Standard Operating ProceduresDocument operating SOPs (e.g. operation, maintenance, cleaning and sanitization) associated with the equipment/system, including controls, undergoing IQ.NOTE: Make copies of this attachment as necessary.NOTE:For computer related systems, SOPs should include failure/backup/recovery, security, system monitoring and maintenance.Document #TitleRev.Rev. DateInitial/Date


List above includes operation, maintenance, cleaning, and sanitization procedures as applicable that are approved and current.

Comments

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ATTACHMENT 12Support Documentation - Equipment/System Calibration ProceduresPage ______ of _______Document the calibration SOPs associated with the critical instruments on equipment/system, including controls, undergoing IQ.NOTE: Make copies of this attachment as necessary.Document #TitleRev.Rev. DateInitial/Date


All calibration procedures associated with the critical instruments on the equipment/system undergoing are approved and current.

Comments

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ATTACHMENT 13 Support Documentation - Equipment/System Calibration ProgramPage ______ of _______Document the equipment/system components (e.g., instruments, controlling/monitoring switches) undergoing IQ that require calibration. Verify that these components are entered into calibration program by reviewing copies of the calibration reports obtained from the Metrology Department. Ensure that all components requiring calibration have been calibrated and are traceable to National Institute of Standards and Technology (NIST), the American Society of Testing and Materials (ASTM), or other applicable standard. Additionally, verify that all calibrated instruments have a calibration tag. Include copies of the calibration reports with this summary package.NOTE: Make copies of this attachment as necessary.NOTE:Instrument verification, process instrument materials of construction verification, and digital sensors and controlling/monitoring switches list will be documented on separate attachments.Component Asset # and DescriptionAssociated CalProcedure #Associated CalProcedure TitleRev.Rev.DateCalFrequencyLast CalDateInitial/Date


Components that require calibration are entered into the calibration program.

Components are traceable to applicable standard.

Components have a tag indicating last cal date and cal due date.

Components are calibrated by the conclusion of protocol execution.

Copies of the calibration reports are included with this summary package.

Comments

Completed by:Date:

Reviewed by:Date:

QA Approval:Date:

ATTACHMENT 14Maintenance - Spare Parts ListPage ______ of _______Document spare parts lists for the applicable equipment/system and associated controls undergoing IQ. Document the location of the manufacturers recommended list (e.g., installation manual).NOTE: Make copies of this attachment as necessary.Equipment/System NameSpare Parts List LocationInitial/Date

AHU-6Form 100.09-MOM1 York International O/M Manual

MAU-14/5/95 Mammoth O/M Manual


Locations of manufacturers recommended spare parts lists are documented.

Comments

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ATTACHMENT 15Maintenance - Lubricant VerificationPage ______ of _______Document lubricants, used with equipment/system undergoing IQ. Using information obtained from the Quality Assurance or Maintenance Departments, the manufacturer, and/or the supplier, verify the lubricants are acceptable for their intended use. Include documentation supporting the acceptability of the lubricants with this summary package. List sources for any information recorded on this page in comments. NOTE: Make copies of this attachment as necessary.Lubricant Typeand ManufacturerPurposeAcceptable?(Yes/No)Initial/Date


All lubricants are acceptable for intended use.

Documentation supporting the acceptability of the lubricants is included with this summary package.

Comments

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Reviewed by:Date:

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Download the accompanying presentation, "Effective Qualification of Critical Utilities," presented at IVT's Validation and cGMP Week Puerto Rico, San Juan, Puerto Rico, July 2011.SHARE ON FACEBOOKFACEBOOKSHARE ON TWITTERTWITTERSHARE ON PINTEREST_SHAREPINTERESTSHARE ON EMAILEMAILMORE SHARING SERVICESADD THISPRINTER-FRIENDLY VERSION

Tags:GMP - Qualification,Facilities Utlities and Equipment

Miguel MontalvoMiguel Montalvo, B.S. Chem. Eng., MBA, President, Expert Validation Consulting, has over twenty-seven years of professional/management experience in positions of increasing responsibility in the areas of Quality,...View Author Bio

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