HVAC Qualification
July 10, 2016 | Author: MuhammadAteeq | Category: N/A
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HVAC...
Description
PROTOCOL
HVAC Installation Qualification Protocol | IVT By Miguel Montalvo Apr 23, 2013 2:16 pm PDT Installation Qualification Protocol Title: HVAC Company X
Protocol No. Effective Date Revision #
1
APPROVAL PAGE System HVAC
Location
Company X, Inc., Address
Protocol Prepared By: Name/Title
Signature
Date
Signature
Date
Protocol Reviewed By: Name/Title
Protocol Technical Reviewed By: Name/Title
Signature
Date
Signature
Date
Protocol Approved By: Name/Title
Table Of Contents 1.0 SYSTEM OVERVIEW 2.0 SYSTEM BOUNDARY 3.0 OBJECTIVE 4.0 SCOPE 5.0 QUALIFICATION STUDY OVERVIEW 6.0 RESPONSIBILITY 7.0 PREREQUSITES 8.0 ACRONYMS 9.0 DEFINITIONS 10.0 GENERAL DOCUMENTATION REQUIREMENTS 11.0 DATA COLLECTION AND DOCUMENTATION PROCEDURES 12.0 INSTALLATION QUALIFICATION TEST REQUIREMENTS 13.0 REFERENCES Index Of Attachments ATTACHMENT 1 – Personnel Identification List ATTACHMENT 2 – Test Equipment Identification/Calibration ATTACHMENT 3 – Test Equipment Operation ATTACHMENT 4 – Equipment / Component Verification ATTACHMENT 5 – Utilities Verification ATTACHMENT 6 – Support Documentation - Equipment/System Specifications ATTACHMENT 7 – Support Documentation - Submittals
ATTACHMENT 8 – Support Documentation – Purchase Orders ATTACHMENT 9 – Support Documentation – Equipment Manuals ATTACHMENT 10 – Support Documentation - Equipment/System Drawings ATTACHMENT 11 – Support Documentation - Equipment/System Standard Operating Procedures ATTACHMENT 12 – Support Documentation - Equipment/System Calibration Procedures ATTACHMENT 13 – Support Documentation - Equipment/System Calibration Program ATTACHMENT 14 – Maintenance - Spare Parts List ATTACHMENT 15 – Maintenance - Lubricant Verification 1.0 SYSTEM OVERVIEW History The 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: 123–125. MAU1 was purchased as part of the building and operated to supply make up air to the AHU6 and rooms 120-125, 111, 113, 114, 117, 118,and both service corridors. Description The 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. AHU–6 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 humidification The system is designed to provide personnel comfort. Performance criteria for the system are: Temperature: 70°F ± 5°F Humidity: 20-80% R.H.
Rationale This 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”. 2.0 SYSTEM BOUNDARY The 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 Utilities
ID Number
Description
Compressed Instrument Air
Inlet at respective valve Supply air to all applicable pneumatic valves on the AHU6
Compressed Instrument Air
Inlet at respective valve Supply air to all applicable pneumatic valves on the MAU-1.
Low Pressure Steam
Inlet at respective valve Supply to appropriate inlets of H-1
Compressed Instrument Air
Inlet at respective valve Supply air to all applicable pneumatic valves on all VAV boxes: 1-9,19-21.
Chilled Water In-AHU-6
CHWS-18
Supply to Cooling Coil-
Chilled Water Out-AHU-6
CHWR-19
Return from Cooling Coil
Hot Water In-AHU-6
HWS-2
Supply to hot water coil-
Hot Water Out-AHU-6
HWR-2
Return from hot water coil
Low Pressure Steam Out-MAU-1
To Be Field Verified
Return from steam reheat coil
Low Pressure Steam In-MAU-1
To Be Field Verified
Supply to steam reheat coil-
Chilled Water Out-MAU-1
To Be Field Verified
Return from cooling coil
Hot Water In-RHC-1
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-1
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-2
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-2
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-3
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-3
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-4
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-4
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-5
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-5
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-6
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-6
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-7
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-7
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-8
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-8
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-9
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-9
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-19
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-19
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-20
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-20
To Be Field Verified
Return from hot water coil
Hot Water In-RHC-21
To Be Field Verified
Supply to hot water coil
Hot Water Out-RHC-21
To Be Field Verified
Return from hot water coil
Chiller-1
To Be Field Verified
Outlet to respective Valve
Chiller-2
To Be Field Verified
Outlet to respective Valve
Chiller-3
To Be Field Verified
Outlet to respective Valve
Hot Water Boilers (7)
To Be Field Verified
Outlet to respective Valves
Low pressure Steam Boilers (10)
To Be Field Verified
Outlet to respective Valves
Electrical
AHU-6
Main Breaker Supply to Unit
Electrical
MAU-1
Main Breaker Supply to Unit
3.0 OBJECTIVE The 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). 4.0 SCOPE This protocol will be limited to the HVAC AHU-6 & MAU-1 System at Company X, Inc., Address 5.0 QUALIFICATION STUDY OVERVIEW During 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. 6.0 RESPONSIBILITY 6.1 Validation Department: 6.1.1 Prepare and submit the protocol for approval in accordance with current industry standards, regulatory requirements, and approved Standard Operating Procedures. 6.1.2 Perform and coordinate the execution of the protocol and recording of all raw data. 6.1.3 Review deviations and support the preparation of all corrective action reports that may be required to resolve discrepant situations.
6.1.4 Prepare and/or coordinate the preparation of a final test report analyzing and summarizing the data and submit for review and approval. 6.2 AAC Consulting Group: 6.2.1 Provide 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. 6.2.2 Assist in the performance of the execution of the test protocol and recording/analysis of the test results. 6.2.3 Assist in the preparation of deviation reports and recommend corrective actions to resolve discrepant situations that may arise during execution of the test protocol. 6.2.4 Assist 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. 6.3 Manufacturing: 6.3.1 Review and approve the test protocol. 6.3.2 Provide qualified personnel to assist with the execution of the protocol and the collection of samples. 6.3.3 Assist in preparation of deviation reports and recommend corrective action to resolve discrepant situations that may arise during execution of the protocol. 6.3.4 Review and approve the final report. 6.4 Engineering and/or Facilities Department: 6.4.1 Review and approve the test protocol. 6.4.2 Provide documentation required for the generation and execution of the protocol. 6.4.3 Provide equipment that has been commissioned and functional as specified by Site Acceptance Test Report. 6.4.4 Provide assistance in evaluating and resolving equipment malfunctions that may be encountered during execution of the protocol. 6.5 Quality Assurance: 6.5.1 Review and approve the test protocol in accordance with the approved SOPs, cGMPs, and current industry guidelines. 6.5.2 Review deviations and support preparation of corrective action reports that may be required to resolve discrepant situations.
6.5.3 Review and approve the final report. 7.0 PREREQUSITES All 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 ACRONYMS AHU
Air Handling Unit
AL
Airlock
CGMP
current Good Manufacturing Practice
CPH
Changes per hour
CAV
Control Air Volume Boxes
EWT
Entering Water Temperature
GPM
Gallons Per Minute
HEPA
High Efficiency Particulate Air
HVAC
Heating, Ventilating, and Air Conditioning
IWG
Inches of Water Gage
LAT
Leaving Air Temperature
LWT
Leaving Water Temperature
MAU
Make-Up Air Unit
NEBB
National Environmental Balancing Bureau
NLT
Not Less Than
NMT
Not More Than
IQ
Installation Qualification
PSI
Pound per Square Inch
PM
Preventive Maintenance
P&ID
Piping and Instrumentation Diagram
RPM
Revolutions Per Minute
SOPs
Standard operating Procedures
RHC
Re Heat Coils
TAB
Testing, Adjusting, and Balancing
VAV
Variable Air Volume (Dampers or Boxes)
5.0 DEFINITIONS Acceptance Criteria The 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 Results A 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. System The 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 reactorcondenser-motor-agitator set-up). 10.0 GENERAL DOCUMENTATION REQUIREMENTS 10.1 Personnel Identification List 10.1.1 All personnel involved in the execution of the protocol must review and complete Attachment 1.
10.1.2 Curriculum 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. 10.2 Test Equipment Identification/Calibration 10.2.1 Document on Attachment 2 the test equipment that is used during execution of this protocol. 10.2.2 All 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. 10.2.3 All 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. 10.3 Test Equipment Operation 10.3.1 Document on Attachment 3 the SOPs and/or Operation Manuals that are required for the test equipment used in the execution of this protocol. 10.4 Protocol Corrections 10.4.1 Protocol corrections must be documented by the issuance of a protocol amendment providing the correct information. 10.5 Raw Data Corrections 10.5.1 Corrections to the raw data must be performed using a single line cross out and explanation with the person’s initials and date. 10.6 Protocol Deviations 10.6.1 A protocol deviation indicates the discovery of discrepant results, methods, information, or procedures resulting from the execution of this protocol. 10.6.2 A discrepancy indicates the discovery of discrepant results. 10.6.3 All 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”. 10.7 Worksheets 10.7.1 Data, other than laboratory data, must be documented on one of the following types of worksheets during the execution of the protocol:
10.7.2 Protocol specific data worksheets, provided in the attachments, are to be used to record data as required. 10.7.3 The General Data Worksheet provided in the attachments, may be customized for additional data collection or clarification. 10.7.4 Copies of raw data from notebook pages or laboratory test results may be attached to this summary package. 11. DATA COLLECTION AND DOCUMENTATION PROCEDURES 11.1 Installation Qualification Worksheets 11.1.1 Each IQ worksheet must be completed as directed on the individual worksheet. 11.1.2 The 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. 11.1.3 All data and results are to be recorded on approved copies of IQ worksheets. 11.1.4 Initial and date each entry and sign and date each worksheet. 11.1.5 Each page of any attachments to the protocol must reference the protocol #, section and page #, and must be initialed and dated. 11.1.6 A summary of results reflecting conclusions for all verifications should be prepared and this document inserted at the beginning of the data package. 11.1.7 The 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 REQUIREMENTS 12.1 Objective 11.1.1 To 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. 12.2 Acceptance Criteria
11.2.1 The acceptance criteria as indicated on each protocol attachment must be met or written explanation providing resolution must be documented. 12.3 Procedure 12.3.1 Complete each protocol attachment as directed on the individual attachment making sure all required data is properly recorded, initialed, and dated. 12.4 Methods of Data Analysis 12.4.1 Review all completed attachments and compare against the acceptance criteria to assure that all criteria have been met. 13. REFERENCES 13.1 ISO-14644-1, Cleanrooms and Associated Controlled Environments, Part 1: Classification of Air Cleanliness, First Edition, 1999-05-01. 13.2 ISO-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. 13.3 ISO-14644-4, Cleanrooms and Associated Controlled Environments, Part 4: Design, Construction, and Start-up , First Edition, 2000-04-01. 13.4 ISO-14644-7, Cleanrooms and Associated Controlled Environments, Part 7: Separative Enclosures (Clean Air Hoods, Gloveboxes, Isolators, Mini-Environments, Draft. 13.5 Title 21, Code of Federal Regulations, Parts 210 and 211 13.6 ICH, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, August 2001. 13.7 Standard Operating Procedures for Reporting and Investigation of Deviations, Metrology Services, Preventive Maintenance, Change Control System”. General Data Worksheet Attachment #__ 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.
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date: ATTACHMENT #1 – Personnel Identification List
Each 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. Name
Title
Signatures
Reviewed by:
Date:
QA Approval:
Date:
Initials
Date
ATTACHMENT 2 – Test Equipment Identification/Calibration Document 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 Description
Model #
Serial #
Tag #
Acceptance Criteria 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:
Last Cal Cal Due Date Date
Criteria Met? (Yes/No/NA)
Initials Date
Initials Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date: ATTACHMENT 3 – Test Equipment Operation
Document 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 #
Title
Current and Effective Documented? Date (Yes/No)
Initial/Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 4 – Equipment / Component Verification (one per each main component including instrumentation/Controls) Description
AIR HANDLING UNIT AHU-6 Specified1
Type
A-Series
Location
Mezzanine above Room 124
ID #
AHU-6
Manufacturer
York International
Model #
AP80FSFCV12X12
Serial #
CADM-005952
Capacity Rating
3400 CFM
Dimensions (L*W*H)
126”x 53”x 43”
Acceptance Criteria
Actual
Initial/Date
Criteria Met?
Initial/
(Yes/No/NA) Actual values conform to specified values. Justifications are provided for actual values that cannot be field verified.
Comments
Specified values taken from Dwg # H-04-rev 2, PO # 30563-05, York International I/O/M Manual, 100.09-nom1. 1
Completed by:
Date:
Reviewed by:
Date:
Date
QA Approval:
Date: ATTACHMENT 5 – Utilities Verification
Document 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 / Purpose
Type ( X ) Plant ( ) Clean
Item Source
Specified1
Actual
Initial/Date
Boiler (7) HydroThermMultiTemp
Regulated Pressure 18 PSI Temp
173 °F
Method of Joining
To be field verified
Acceptance Criteria 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
Criteria Met? (Yes/No/NA)
Initial/ Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 6 – Support Documentation - Equipment/System Specifications Document 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.
Type
Title/Description
Doc. #
Location
Initial/Date
Acceptance Criteria 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
Criteria Met? (Yes/No/NA)
Initial/ Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 7 – Support Documentation - Submittals List 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. Initials Date
Description:
Acceptance Criteria The submittals have been verified to accurately describe and document the system being qualified. Copies of the approved submittals for the
Criteria Met? (Yes/No/NA)
Initials Date
system and components are attached.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 8 – Support Documentation - Purchase Orders List the purchase orders supporting the system and system components. Include a copy of each purchase order with this protocol. Description
Purchase Order Number
Air Handler AHU-6
30563-05
Variable Air Volume Box
30563-12
Heating/Cooling Coils
30563-05
Initials Date
Exhaust Fans
30563-12
Humidifier H-1
30563-07
Criteria Met? (Yes/No/NA)
Acceptance Criteria
Initials Date
The system being qualified conforms to the PO requirements. Copies of the purchase orders for the system and system components are attached.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 9 – Support Documentation - Equipment Manuals
Verify that pertinent equipment documentation exists and reference the location where the document is kept. Title
Location
Acceptance Criteria The manufacturers equipment manuals are described above and the location of each manual is documented.
Comments
Criteria Met? (Yes/No/NA)
Initials/Date
Initials/Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 10 – Support Documentation - Equipment/System Drawings Document 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 #
Title
Acceptance Criteria
Rev. Rev. Date
Initial/Date
Criteria Met?
Initial/
(Yes/No/NA) 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
Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 11 – Support Documentation - Equipment/System Standard Operating Procedures Document 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 #
Title
Acceptance Criteria
Rev.
Rev. Date
Initial/Date
Criteria Met? (Yes/No/NA)
Initial/ Date
List above includes operation, maintenance, cleaning, and sanitization procedures as applicable that are approved and current.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 12 – Support Documentation - Equipment/System Calibration Procedures Page ______ 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 #
Title
Rev.
Rev. Date
Initial/Date
Criteria Met? (Yes/No/NA)
Acceptance Criteria
Initial/ Date
All calibration procedures associated with the critical instruments on the equipment/system undergoing are approved and current.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 13 – Support Documentation - Equipment/System Calibration Program Page ______ 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 Description
Associated Cal Procedure #
Associated Cal Procedure Title
Rev.
Rev. Cal Last Cal Initial/ Date Frequency Date Date
Acceptance Criteria 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
Criteria Met? (Yes/No/NA)
Initial/ Date
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date: ATTACHMENT 14 – Maintenance - Spare Parts List Page ______ of _______
Document spare parts lists for the applicable equipment/system and associated controls undergoing IQ. Document the location of the manufacturer’s recommended list (e.g., installation manual). NOTE: Make copies of this attachment as necessary. Equipment/ System Name
Spare Parts List Location
AHU-6
Form 100.09-MOM1 York International O/M Manual
MAU-1
4/5/95 Mammoth O/M Manual
Initial/ Date
Criteria Met? (Yes/No/NA)
Acceptance Criteria
Initial/ Date
Locations of manufacturer’s recommended spare parts lists are documented.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
ATTACHMENT 15 – Maintenance - Lubricant Verification Page ______ 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 Type and Manufacturer
Purpose
Acceptable? (Yes/No)
Initial/ Date
Criteria Met? (Yes/No/NA)
Acceptance Criteria
Initial/ Date
All lubricants are acceptable for intended use. Documentation supporting the acceptability of the lubricants is included with this summary package.
Comments
Completed by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
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 THIS PRINTER-FRIENDLY VERSION
Tags: GMP - Qualification, Facilities Utlities and Equipment Miguel Montalvo Miguel 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
Comments (1) Mr. anuj kumar Singh May 9, 2014 11:41 pm PDTReply Nice Documents
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