Professional Documents
Culture Documents
Protocol No.
Effective Date
Revision #
APPROVAL PAGE
System
HVAC
Location
Signature
Date
Signature
Date
Signature
Date
Signature
Date
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
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
CHWS-18
CHWR-19
HWS-2
HWR-2
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
To Be Field Verified
Chiller-1
To Be Field Verified
Chiller-2
To Be Field Verified
Chiller-3
To Be Field Verified
To Be Field Verified
To Be Field Verified
Electrical
AHU-6
Electrical
MAU-1
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:
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.
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.
AL
Airlock
CGMP
CPH
CAV
EWT
GPM
HEPA
HVAC
IWG
LAT
LWT
MAU
NEBB
NLT
NMT
IQ
Installation Qualification
PSI
PM
Preventive Maintenance
P&ID
RPM
SOPs
RHC
Re Heat Coils
TAB
VAV
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 persons 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
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:
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:
Type
A-Series
Location
ID #
AHU-6
Manufacturer
York International
Model #
AP80FSFCV12X12
Serial #
CADM-005952
Capacity Rating
3400 CFM
Dimensions (L*W*H)
126x 53x 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
Completed
by:
Date:
Reviewed by:
Date:
Date
QA Approval:
Date:
ATTACHMENT 5 Utilities Verification
Item
Source
Specified1
Actual
Initial/Date
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:
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:
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
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Purchase Order
Number
30563-05
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
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
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:
Title
Acceptance Criteria
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:
Title
Acceptance Criteria
Rev.
Rev. Date
Initial/Date
Criteria Met?
(Yes/No/NA)
Initial/
Date
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Title
Rev.
Rev. Date
Initial/Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
Initial/
Date
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
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 manufacturers recommended list (e.g.,
installation manual). NOTE: Make copies of this attachment as necessary.
Equipment/
System Name
AHU-6
MAU-1
Initial/
Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
Initial/
Date
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
Purpose
Acceptable?
(Yes/No)
Initial/
Date
Criteria Met?
(Yes/No/NA)
Acceptance Criteria
Initial/
Date
Comments
Completed
by:
Date:
Reviewed by:
Date:
QA Approval:
Date:
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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