Standard Operating Procedure for DQ, URS Preparation, Installation, Operation and Performance Qualification of Quality Control Instruments
1.0 Purpose:
To lay down a procedure for User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operation and Performance Qualification (OPQ) of Quality Control Instruments.
2.0 Scope:
The scope of this SOP is applicable for User Requirement Specification (URS), Design Qualification (DQ), Installation Qualification (IQ), Operation and Performance Qualification (OPQ) of Quality Control Instruments at [Company name].
3.0 Responsibility:
3.1 QC-Personnel:
- Preparation of URS.
- Preparation of Installation Qualification Protocol and Report.
- Preparation and review of Operation and Performance Qualification Protocol and Report.
- Execution of Installation Qualification (IQ) Protocol of Quality control instrument.
- Execution of Operation and Performance Qualification (OPQ) protocol of Quality control instrument.
- Preparation of Traceability Matrix.
3.2 Head – QC and Site QA:
- Monitoring the activity.
- To review the URS.
- To review the Installation Qualification Protocol and Report.
- To review the Operation and Performance Qualification Protocol and Report.
- To review Vendor’s format Protocol and Report.
- Review of Traceability Matrix.
3.3 Site Head Engineering:
- To review the URS.
- Monitoring the activity.
- To review the Installation Qualification Protocol and Report.
- To review the Operation and Performance Qualification Protocol and Report.
- To review Vendor’s format Protocol and Report.
3.4 Site Quality Head :
- To approve the URS.
- To approve the Installation Qualification Protocol and Report.
- To approve the Operation and Performance Qualification Protocol and Report.
- To approve Vendor’s format Protocol and Report.
3.5 Instrument/ Equipment Vendor:
3.5.1 To provide qualification document that vendor includes IQ and OQ or Installation and Operation qualification (IOQ) or Operation and Performance qualification document as per User Requirement Specification (URS).
4.0 Definitions:
Not applicable
5.0 Procedure:
5.1 Ensure Qualification exercise is as per the pre-designed approved protocol.
5.2 URS shall not be required for standard Equipment / Instrument or the Equipment / Instrument Manufacturer having monopoly. All major instruments require URS. URS shall be prepared and numbered as per SOP for preparation of URS.
5.3 Note: For legacy instrument URS might not be available for standard equipment / instrument or the equipment/instrument manufacture having monopoly.
5.4 IQ report shall be reviewed and Post-approved before carrying out OQ or OPQ, although depending on the complexity of the equipment; it may be performed as combined Installation and Operation Qualification (IOQ) or Operation and Performance (OPQ). In case of IOQ or OPQ shall be performed, Protocol shall be pre-approved for IQ and OQ and PQ. In case of any of the portion of document is not provided by Vendor, it shall be prepared by making amendment as per Company’s SOP or vendor can be provide an amendment. Amendment shall undergo same approval mechanism.
5.5 Before Installation ensure that power supply coming from UPS is stable, wherever applicable.
5.6 Design the protocol based on requirements.
5.7 All certificates like such as MOC Certificates, Test Certificates, Calibration Certificates etc, shall be available during IQ and shall be attached with qualification document along with traceability certificate as applicable.
5.8 All activity shall be done in accordance with approved protocol and all observation shall be recorded during execution of the qualification.
5.9 Qualification shall be carried out as per vendor format or Company format as per availability.
5.10 After execution and completion of activity, all data shall be reviewed properly, and traceability matrix shall be prepared and post approval of report shall be done.
5.11 Prior to OPQ, instruments shall be qualified for IQ.
5.12 OPQ reports shall be reviewed by Head-QC, Site Head Engineering, Site-QA and approved by Site Quality Head. The instrument shall be released for routine analysis only after final approval of OPQ report by Site Quality Head and after calibration of the instrument.
5.13 On the basis of the level needed, it is convenient to categorize instruments into three groups: A, B, and C.
5.13.1 Group A: Group A includes standard equipment with no measurement capability or usual requirement for calibration, where the manufacturer’s specification of basic functionality is accepted as user requirements. Conformance of Group A equipment with user requirements may be verified and documented through visual observation of its operation. Examples of equipment in this group are nitrogen evaporators, magnetic stirrers, vortex mixers, and centrifuges.
5.13.2 Group B: Group B includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters (such as temperature, pressure, or flow) that need calibration, where the user requirements are typically the same as the manufacturer’s specification of functionality and operational limits. Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instrument or equipment, and documented during IQ and OQ. Examples of instruments in this group are balances, melting point apparatus, light micro- scopes, pH meters, variable pipets, Refractometer, thermometers, Titrator, and viscometer. Examples of equipment in this group are muffle furnaces, ovens, refrigerator-freezers, water baths, pumps, and dilutors.
5.13.3 Group C: Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specific for the analytical application. Conformance of Group C instruments to user requirements is determined by specific function tests and performance tests. Installing these instruments can be a complicated undertaking and may require the assistance of specialists. A full qualification process, as outlined in this document, should apply to these instruments. Examples of instruments in this group include the following but not limited to:
- Atomic absorption spectrometers
- Differential scanning calorimeters
- Dissolution apparatus
- Electron microscopes
- Flame absorption spectrometers
- High-pressure liquid chromatographs
5.14 Handle the parts of the instrument carefully during qualification activity.
5.15 All safety related precaution should be taken during qualification of equipment and system. Required PPE shall be used to carryout respective tests.
5.16 Preparation URS:
5.16.1 User Department/ Functional Department, Engineering Department and QA Department shall finalize requirement of Equipment/ Instrument. For Group A equipment, the manufacturer’s specification of basic functionality is accepted as user requirements.
5.16.2 User Department shall prepare URS of the Equipment/ Instrument in consultation with Department Head.
5.16.3 Approved URS shall be forwarded to Project/ Engineering department for Procurement of the Equipment/ Instrument.
5.16.4 The URS format shall contain the important contents for selecting the Equipment/ Instrument as per respective Format.
5.17 Procedure for Design Qualification (DQ):
5.17.1 Design qualification (DQ) is the documented collection of activities that define the functional and operational specifications of the instrument and criteria for selection of the vendor, based on the intended purpose of the instrument. Design qualification (DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. DQ shall be reviewed and approved as per respective Format.
5.18 Procedure for Installation Qualification (IQ):
5.18.1 Before the Installation, Site Engineering shall ensure respective area/ room should be properly constructed and suitable for installation.
5.18.2 Installation Qualification shall be performed as per vendor format, consultant format or Company format.
5.18.3 The Installation Qualification document shall be reviewed & pre-approved with respect to URS, Specification to Qualification.
5.18.4 Document shall be generated to detail specific attributes of equipment/ instrument, in order to prove that the Installation of the Equipment/ System has been correctly performed and the installation specification of the manufacturer has been met.
5.18.5 Installation Qualification shall be include following, but is not limited to,
- Verification of the correct installation of components, instrumentation against the URS and Instrument Hardware and Software specification.
- Collection and Collation of supplier operating and working instructions and maintenance requirements.
- Verify the major component shall be described and verified along with technical specification of instrument and URS.
- Verification of Supporting Utilities
- Verify the instrument make, model; instrument Capacity, Software CD along with traceability certificate, place of installation, Room space, physical damage, electric connection etc.
5.18.6 In case where Vendor provides IQ Protocol and Report, it shall be pre-approved as per respective Format and after execution, it shall be post approved as per respective Format.
5.18.7 Procedure for execution of pre-approval format (Vendor Qualification format pre-approval):
- In case where vendor provides the IQ /OQ/PQ protocol for qualification of an instrument or equipment, protocol shall be reviewed and verified by user department / QA department for the requirement.
- Pre-Approval format shall be issued from QA department before execution of qualification.
- All the details mentioned below shall be documented in pre-Approval format.
- Details covers below mentioned points;
- Instrument/ Equipment name
- Instrument/ Equipment ID. No.
- Make & Model No.
- Department: Mention user department name
- Instrument/ Equipment Location
- Movable/ Non movable
- Group (A/B/C): shall be classified as per respective point no.
- Change Control No.: Approved change control number shall be mentioned for Qualification of Instrument / Equipment.
- Protocol No. & Rev. No: Internal protocol No. to be allocated.
- Effective Date: Date of approval of pre-Approval format.
- Vendor Qualification Protocol No.: Protocol number of Vendor to be executed.
- After documenting all the above details, all the checkpoints defined in the checklist shall be assessed by user department.
- In Case the checkpoints are applicable to that particular document- /- activity shall be mention as “YES” in the checklist. If not applicable shall be mention as “NO” in the column provided. In case of any omissions in contractor challenged, reference shall be provided in the checklist additional internal validation exercises. Respective IQ/OQ/PQ pre approval checklist shall be used in case of qualification protocol. The checklist shall prompt the executional listed qualification activities such as SOP for qualification is followed and all required qualification process is executed.
- Wherever mentioned “YES”, related document verification shall be mentioned in the Vendor protocol.
- For example: During Installation Qualification, Identification of calibration of instruments used during qualification is to be mentioned it shall me mentioned as “YES” is applicable. Provision for verification of the instrument calibration status shall be in the vendor protocol. In provision is not in vendor protocol, column for available shall be mentioned as “NO”.
- In case checkpoints mentioned in the format do not comply, addendum to the Qualification protocol shall be done to cover individual content if any, which is applicable and not covered in Qualification protocol of the vendor.
- After assessment by user department it shall be reviewed by QA department and finally approved.
- After approval of “Pre approval format” for vendor qualification protocol shall be executed.
5.18.8 If Vendor doesn’t provide IQ Protocol and Report, it shall be prepared by the QC personnel as per respective Format.
5.18.9 IQ Protocol shall be prepared by Quality Control personnel with the detail of specific attributes of instrument, in order to prove correct Installation of the Instrument.
5.18.10 IQ Protocol shall be numbered as QC/IQ/YYYXX where,
QC – Quality Control.
IQ – Installation Qualification.
YYYXX – Instrument Identification Number
5.18.11 While performing re-qualification of the same Instrument the Protocol number will remain the same only the revision number shall change.
5.18.12 Any deviation with respect to approved IQ protocol shall be described in the Installation Qualification, necessary Corrective Action shall be taken and same shall be approved by Site Quality Head.
5.18.13 All critical Installation checks & Quality Attributes shall be covered in Installation Qualification Protocol.
5.18.14 Based on verification results and acceptance criteria, the Instrument / System shall be concluded for further action.
5.18.15 Any modification or additional part if attached to the Instrument, the addendum should be attached to IQ Report.
5.18.16 The Protocol and Report shall be written in a template form using Times New Roman font and of size 12.
5.19 Procedure for Operation and Performance Qualification (OPQ) :
5.19.1 User department shall make co-ordination with Manufacturer / Supplier Consultant for Operation and Performance Qualification activity and related documents.
5.19.2 The Operation and Performance Qualification document shall be reviewed by Engineering, User department and QA Department & pre-approved by Quality Assurance prior to Qualification.
5.19.3 If Vendor doesn’t provide OPQ Protocol and Report, it shall be prepared by the QC personnel as per respective Format.
5.19.4 The Protocol and Report shall be written in a template form using Times New Roman font and of size 12.
5.19.5 In case where Vendor provided OPQ Protocol and Report shall be pre and post approved as per respective format.
5.19.6 OQ Protocol shall be numbered as QC/OQ/YYYXX where,
QC – Quality Control.
OQ – Operation Qualification.
YYYXX – Instrument Identification Number
5.19.7 Approved Operation and Performance Protocol shall be used for data recording and shall include following, but not limited to;
- Instrument Calibration verification
- Verification of Utilities
- Identification and verification if finalization (draft copy) of standard procedure for operation, cleaning and calibration.
- Identification of Standard Procedure and other related documents
- Verification of Key Functionality and Operating Parameter
- Verification of Safety Feature / Interlock / Alarm and verify that all alarm test are covered under protocol.
- Verification power/Communication Failure
- Verification of operator training on equipment/instrument
- Verification of test for transition between regular and stand by system
- Verification of preventive maintenance / annual maintenance/ calibration schedule
- Any other validation required which is equipment specific (to be identified by cross functional team during review)
5.19.8 Each test shall be evaluated against its acceptance criteria wherever applicable.
5.19.9 Operational parameter shall be evaluated which include a condition or a set of condition encompassing upper and lower limits.
5.19.10 QC personnel (User department) shall record the observations, values set during OPQ for alarm generation or any value altered during the qualification from the set values shall be documented in the Vendor protocol/Internal protocol prepared. Vendor protocol /internal protocol shall have provision to document such values.
5.19.11 Also after the study executed and final settings / configuration for the alarm values or any altered values, set shall be documented in the protocol and shall be verified against the acceptance criteria and note the remarks in protocol or report.
5.19.12 During qualification, temperature mapping of any Stability chamber/Cooling cabinet/Deep freezer is to be performed in loaded / unloaded conditions and evidence in the form of photographs shall be attached to the qualification documents.
5.19.13 Prior to Post-approval of Operation Qualification protocol, Traceability Matrix shall be prepared to ensure all requirements of URS has been met and final approval shall be taken.
5.19.14 Any deviation in the Operation shall be noted in the Operation Qualification report.
5.19.15 OPQ Protocol and Report shall be reviewed by Head- QC, Site Engineering and Site-QA.
5.19.16 OPQ Protocol and Report shall be finally approved by Site Quality Head.
5.19.17 While performing re-qualification of the same instrument the protocol number will remain the same only the revision number shall change.
5.19.18 After OPQ protocol approval, execution of the protocol shall be done by QC personnel and OQ shall be carried out in the presence of Engineering and QA personnel.
5.19.19 Operation Qualification Certificate shall be certified by Site Quality Head.
5.19.20 Any modification or additional part if attached to the Instrument, the addendum should be attached to OQ Report.
5.19.21 After post approval of operation and Performance Qualification, instrument release for Calibration.
5.19.22 If calibration result is found with in limit instrument can be release for Analysis.
6.0 Acceptance Criteria:
Should comply with each designated parameter as per individual protocol.
7.0 Frequency:
During new instrument installation and during re-location of instrument.
8.0 Format for recording:
8.1 User Requirement Specification
8.2 Approval of Design Qualification
8.3 Installation Qualification (IQ) protocol
8.4 Pre-Approval for Installation Qualification Protocol (Vendor Format)
8.5 Post Approval of Installation Qualification (Vendor format)
8.6 Operation and Performance Qualification protocol
8.7 Pre- Approval for Operation and performance Qualification Protocol (Vendor Format)
8.8 Post- Approval for OPQ Protocol (Vendor Format)
User Requirement Specification for “Specify the equipment name/instrument (details)/Condition
| Equipment / Instrument Name | |
| Capacity | |
| GAMP Category | |
| Purpose | |
| Scope | |
| References (if any) | |
| Functional Requirement / System Overview | |
| Business Requirements | |
| Interface Requirements | |
| Security and Safety Requirements with respect to Software | |
| Electronic Records, Reports and Electronic Signature Requirements | |
| Audit trail Requirements | |
| Backup, Archival and Restoration Requirements | |
| Performance Requirements with respect to Software | |
| Operation/ Maintenance and Support Requirement with respect to Software | |
| Level of Automation and Alarm | |
| Software Validation | |
| Instrumentation and Calibration | |
| Utility Requirement | |
| GMP Features | |
| Material of Construction | |
| Surface Finish | |
| Cleanliness requirement | |
| Safety Features | |
| Documentation | |
| Equipment Manual | |
| Operating, Cleaning and Preventive Maintenance Procedures | |
| Design, Installation, Operational, Performance Qualification | |
| Calibration Certificate | |
| MOC and Surface finish Certificates | |
| Product Contact Surface Area in (m2) (if any requirement) | |
| Other (if Any) | |
| Attachment (if any) |
Prepared By
| QC personnel |
Reviewed By
| Head QC | Head Engineering | IT Department | Head QA |
Approved By
| Plant Head Operations | Site Quality Head |
Vendor Response on URS:
Sign of Vendor:
Company’s acceptance on Vendor’s comments on URS:
Reviewed By
| Head QC | Head Engineering | IT Department | Head QA |
Approved By
| Plant Head Operations | Site Quality Head |
Approval of Design Qualification
APPROVAL OF DESIGN QUALIFICATION
This is to certify that Design Qualification of
Equipment / Instrument Name: ___________________________________________
Equipment No: _________________________________________________
Document No. : _____________________________________ is approved and can
be proceed for Installation Qualification.
| Head – QC | Head -Engineering | QA Person | QA Head | Site Quality Head |
DOCUMENT ASSESSMENT CHECKLIST
| Sr. No. | Title of DQ Content | Applicable (Yes / No) | Available (Yes / No / NA) |
| Description of System / Instrument | |||
| Major Component | |||
| Specification of Technical Component | |||
| Functional and operational specifications | |||
| Details of Safety features / Alarms / Interlocks | |||
| Detailed Drawings and lay out, P&ID, and Electric wiring diagram (Optional) | |||
| Detail of utilities requirement | |||
| Meeting to User Requirement Specification |
| Acceptance Remarks For DQ: Remarks: Addendum to the Design Qualification protocol shall be done to cover individual content if any of the above listed content, which is applicable and not covered in design qualification protocol of the vendor. |
Assessment Done by
| User Department Person Sign & Date | Engineering Department/ Sign & Date |
Reviewed by
| Quality Assurance/ Sign & Date |
Installation Qualification Protocol
| Instrument Name | |
| Instrument Code No. | |
| Make & Model No. | |
| Instrument location | |
| SOP Ref. No. | |
| Movable / Non Movable | |
| Group (A / B/ C) | |
| Change Control No. | |
| Protocol No.& Rev No. | |
| Effective Date |
| PREPARED BY | SIGN | DATE |
| QC Personnel |
| REVIEWED BY | SIGN | DATE |
| Head – QC | ||
| Site Head Engineering | ||
| QA Person | ||
| Head-QA |
| APPROVED BY | SIGN | DATE |
| Site Quality Head |
1.0 Table Content:
| Sr. No. | Content | Page No. |
| Table of Content | ||
| Revision history | ||
| Objective | ||
| Scope | ||
| Responsibility | ||
| Equipment / system description | ||
| Pre-installation checks | ||
| Installation Qualification and Test results | ||
| Summary Report and Conclusion | ||
| Deviation and Corrective action report | ||
| Re-Qualification Criteria | ||
| Abbreviation | ||
| Post Approval |
2.0 Revision History:
Sr. No
Rev. No.
Revision Date
Reason for Revision
3.0 Objective
4.0 Scope
5.0 Responsibility
6.0 Instrument / System Description
7.0 Pre – installation checks
7.1. Procedure
7.2. Acceptance criteria
7.3. Result
| Sr. No. | Checkpoints | Description / Observation | Remarks |
| Name of Instrument | |||
| Purpose of selection | |||
| Manufacturer’s name, address, contact number, E – mail id, Fax No., contact person | |||
| Receiving date | |||
| Purchase Order No. | |||
| DQ Approval Date |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.0 Installation Qualification and Test Results
8.1. Installation Check list
8.1.1. Procedure
8.1.2. Acceptance criteria
8.1.3. Result
| Sr. No. | Checkpoints | Description / Observation | Remarks |
| Name of Instrument | |||
| Name of Manufacturer | |||
| Model No. | |||
| Manufacturers Sr. No. | |||
| Capacity | |||
| Instrument ID No. | |||
| Name of department | |||
| Place of installation | |||
| Ensured that the description of machine is satisfactory. | |||
| Ensured that the pre installation is satisfactory. | |||
| Verify that major components are securely anchored and protected from shock. | |||
| Verify that there is no observable physical damage. | |||
| Verify that there is sufficient room for servicing provided. | |||
| Required Electric connectors are insulated, weather proofed and grounded. | |||
| Equipment identification number plate visible. | |||
| Equipment installed on foundation and secured in place as per manufacturer’s recommendations. | |||
| Verification of required environment for instrument. | |||
| Network and Data Storage requirement verification | |||
| Others (Specify if any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer/ QC User Dept. QA
8.2. Verification of Major Technical Component, Assembly and Installation and its Specification:
8.2.1. Procedure
8.2.2. Acceptance criteria
8.2.3. Result
| Sr. No. | Name of Components / Accessories | Specification | Results (Satisfactory / Not Satisfactory) | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.3. Identification of Supporting Utilities
8.3.1. Procedure
8.3.2. Acceptance criteria
8.3.3. Result
| Sr. No. | Utilities | Properly connected and identified (Y/N/NA ) | Remarks |
| Electrical (Specify requirement) | |||
| Compressed Air (Specify requirement) | |||
| Water (Specify requirement) | |||
| Others (Specify if any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.4. Identification of supporting Instruments for Calibration
8.4.1. Procedure
8.4.2. Acceptance criteria
8.4.3. Result
| Sr. No. | Instrument Name | Instrument ID No. | Calibration Valid up to | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.5. Identification of Safety features / Interlocks / Alarms
8.5.1 Procedure
8.5.2 Acceptance criteria
8.5.3 Result
| Sr. No. | Safety features / Interlocks / Alarms | Observation (Available / Not Available) | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.6. Identification of SOP and other related documents
8.6.1 Procedure
8.6.2 Acceptance criteria
8.6.3 Result
| Sr. No. | Name of SOP/Documents | Origination / Responsable Département | Status | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.7. Verification of Reference documents
8.7.1. Procedure
8.7.2. Acceptance criteria
8.7.3. Result
| Sr. No. | Document Name | Document Number | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
9.0 Summary Report and Conclusion
Summary Report:
| Sr. No. | Document | Satisfactory / Not Satisfactory |
| 1. | Pre-installation checks | |
| 2. | Installation check list | |
| 3. | Verification of Major Technical Component and its Specification | |
| 4. | Identification of supporting utilities | |
| 5. | Identification of instruments for Calibration | |
| 6. | Identification of Safety feature / Interlock / Alarm | |
| 7. | Identification of SOP and other related documents | |
| 8. | Verification of Reference documents | |
| 9. | Others (specify if any) |
Conclusion:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
10.0 Deviation and Corrective Action Report
11.0 Re-Qualification Criteria
12.0 Abbreviation
13.0 Post Approval
| REVIEWED BY | SIGN | DATE |
| Head – QC | ||
| Site Head Engineering | ||
| QA Person | ||
| Head-QA | ||
| APPROVED BY | SIGN | DATE |
| Site Quality Head |
Pre-Approval for Installation Qualification Protocol (Vendor Format)
| Instrument Name | |
| Instrument ID. No. | |
| Make & Model No. | |
| Department | |
| Instrument location | |
| Movable / Non Movable | |
| Group (A / B/ C) | |
| Change Control No. | |
| Protocol No. & Rev No: | |
| Effective Date | |
| Vendor Qualification Protocol No. / Rev. No. |
| REVIEWED BY | SIGN | DATE |
| Head – QC | ||
| Site Head Engineering | ||
| QA Personnel | ||
| Head-QA | ||
| APPROVED BY | SIGN | DATE |
| Site Quality Head |
DOCUMENT ASSESSMENT CHECKLIST
| Sr. No. | Title of IQ Content | Applicable (Yes / No) | Available (Yes / No / NA) |
| Verification of the correct installation of components, instrumentation, Equipment, pipe work and services against the engineering drawings and Specifications | |||
| Collection and collation of supplier operating and working instructions and maintenance requirements | |||
| Verification of required environment for the system | |||
| Identification of calibration of instrumentation | |||
| Verification against approved drawings and lay out (Optional) | |||
| Verification of Major Technical Component and its Specification | |||
| Verification of supporting utilities | |||
| Identification of safety features / Interlocks /Alarms | |||
| Verification of Network and Data Storage | |||
| Identification field instrument. Verification of instrument for its calibration. If not calibrated, it requires calibrating during IQ. | |||
| Identification of SOP for operation, cleaning, maintenance and calibration etc. and other necessary documents |
Acceptance Remarks for IQ:
Remarks: Addendum to the Installation Qualification protocol shall be done to cover individual content if any of the above listed content, which is applicable and not covered in Installation Qualification protocol of the vendor.
Details of the Addendum to Installation Qualification protocol for additional internal validation exercise :
| Sr. No. | Document Title | Approval Date | Reason for Addendum |
Assessment Done by
| User Department Sign & Date | QC Head Sign & Date |
Reviewed by
| Quality Assurance Sign & Date |
Tracker for additional Addendum to Installation Qualification protocol:
| Sr. No. | Document Title | Approval Date | Reason for Addendum | Updated By |
Post- Approval for Installation Qualification Protocol (Vendor Format)
This is to certify that Installation Qualification of
Instrument Name: _________________________________________________
Instrument Id. No.: ______________________________________________
is approved and can be proceed for Operation and Performance Qualification.
| Head -QC | Head-QA Sign & Date | Site Quality Head Sign & Date |
Operation and Performance Qualification Protocol
1.0 Table Content
| Sr. No. | Content | Page No. |
| Table of Content | ||
| Revision history | ||
| Objective | ||
| Scope | ||
| Responsibility | ||
| Equipment / system description | ||
| Operation Qualification and Test results | ||
| Summary Report & Conclusion | ||
| Deviation and Corrective Action report | ||
| Re-Qualification criteria | ||
| Abbreviation | ||
| Traceability Matrix | ||
| Post Approval |
2.0 Revision History
| Sr. No. | Rev. No. | Revision Date | Reason for Revision |
3.0 Objective
4.0 Scope
5.0 Responsibility
6.0 Instrument / System Description
7.0 Operation Qualification and Test Results
7.1. Verification of Instrument Calibration Status
7.1.1. Procedure
7.1.2. Acceptance criteria
7.1.3. Result
| Sr. No. | Instrument Name | Instrument ID No. | Calibration Status | Valid up to | Certificate No. |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.2. Verification of finalization (draft copy) of SOP and Other Related Documents
7.2.1. Procedure
7.2.2. Acceptance criteria
7.2.3. Result
| Sr. No. | Name of SOP/Documents | Originating / Responsible dept. | Status | Remarks |
| Operation of Equipment /system | ||||
| Cleaning of Equipment | ||||
| Preventive Maintenance / Annual maintenance /Calibration Schedule | ||||
| Others (Specify if any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.3. Verification of Key Functionality
7.3.1. Procedure
7.3.2. Acceptance criteria
7.3.3. Result
| Sr. No. | Keys / Components of control panel / Main Panel / Touch screen Operation / Mechanical Operations | Specification | Observation | Results (Satisfactory / Not Satisfactory) |
Comments:
Done by: Checked by: Reviewed by:
Engineer/QC User Dept. QA
7.4. Verification of Operating Parameter
7.4.1. Procedure
7.4.2. Acceptance criteria
7.4.3. Result
| Sr. No. | Operating Parameters | Specification | Observations | Results (Satisfactory / Not Satisfactory) |
Comments:
Done by: Checked by: Reviewed by:
Engineer/QC User Dept. QA
7.5. Verification of Performance check
7.5.1. Procedure
7.5.2. Acceptance criteria
7.5.3. Result
| Sr. No. | Performance Parameters | Specification | Observations | Results (Satisfactory / Not Satisfactory) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.6. Verification of Safety Features / Interlocks / Alarms
7.6.1. Rationale
7.6.2. Procedure
7.6.3. Acceptance criteria
7.6.4. Result
| Sr. No. | Parameters (Safety Features / Interlocks / Alarms) | Specification | Observations | Results (Satisfactory / Not Satisfactory) |
| 1. | Emergency switch | |||
| 2. | Noise level | |||
| 3. | All alarm tests are covered | Number of alarms:_____ | Number of alarms tests checked:_____ | |
| 4. | Others (Specify if any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.7. Verification of Power / Communication failure and its Recovery
7.7.1. Rationale
7.7.2. Procedure
7.7.3. Acceptance criteria
7.7.4. Result
| Sr. No. | Action | Specification | Observations | Results (Satisfactory / Not Satisfactory) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.8. Verification of Operator training on equipment/instrument
7.8.1. Procedure
7.8.2. Acceptance criteria
7.8.3. Result
| Sr. No. | Employee Name | Employee Code | Designation | Results (Satisfactory / Not Satisfactory) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.9. Verification of Utilities
7.9.1 Procedure
7.9.2 Acceptance criteria
7.9.3 Result
| Sr. No. | Utilities | Specification | Observation | Results (Satisfactory / Not Satisfactory) |
| 1. | Electrical (Specify Requirement) | |||
| 2. | Compressed Air (Specify Requirement) | |||
| 3. | Water (Specify Requirement) | |||
| 4. | Others (Specify if any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.10 Verification of test for transition between regular and standby system.
7.10.1 Procedure
7.10.2 Acceptance criteria
7.10.3 Result
| Sr. No. | Transition Study | Specification | Observation | Results (Satisfactory / Not Satisfactory) |
| 1. | Regular to Standby | |||
| 2. | Standby to Regular | |||
| 3. | Others (If any) |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.11 List of Instruments used in Operation Qualification
7.11.1 Procedure
7.11.2 Acceptance criteria
7.11.3 Result
| Sr. No. | Instrument Name | Make / Model | Instrument ID | Calibration Valid Up to | Remarks |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.12 Verification of Reference documents
7.12.1 Procedure
7.12.2 Acceptance criteria
7.12.3 Result
| Sr. No. | Document Name | Document Number | Remarks |
| 1. | |||
| 2. | |||
| 3. | |||
| 4. |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
7.13 Any other validation required which is equipment specific (to be identified by cross functional team during review)
7.11.1 Procedure
7.11.2 Acceptance criteria
7.11.3 Result
| Sr. No. | Any other additional validation | Observation | Results (Satisfactory / Not Satisfactory) |
| 1. | |||
| 2. | |||
| 3. | |||
| 4. |
Comments:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
8.0 Summary Report and Conclusion
Summary Report:
| Sr. No. | Document | Satisfactory / Not Satisfactory |
| 1. | Verification of Instrument Calibration Status | |
| 2. | Verification of finalization (draft copy) of SOP and Other Related Documents | |
| 3. | Verification of Key Functionality | |
| 4. | Verification of Operating Parameter | |
| 5. | Verification of Safety Features / Interlocks / Alarms | |
| 6. | Verification of Operator training on equipment/instrument | |
| 7. | Verification of Power / Communication failure and its Recovery | |
| 8. | Verification of Utilities | |
| 9. | Verification of test for transition between regular and standby system. | |
| 10. | List of Instruments used in Operation Qualification | |
| 11. | Verification of Reference documents | |
| 12. | Any other validation required which is equipment specific (to be identified by cross functional team during review) |
Conclusion:
Done by: Checked by: Reviewed by:
Engineer / QC User Dept. QA
9.0 Deviation and Corrective Action Report
10.0 Re-Qualification Criteria
11.0 Abbreviation
12.0 Traceability Matrix
| Sr. No. | URS Point no. | Description of URS point | Qualification Document / Test Number | Status | Remarks |
Acceptance Remarks for Traceability Matrix:
Done by
| User Department Sign & Date | QC Head Sign & Date |
Reviewed by
| Quality Assurance Person Sign & Date |
13.0 Post Approval
| REVIEWED BY | SIGN | DATE |
| Head – QC | ||
| Site Head Engineering | ||
| QA Person | ||
| Head-QA |
| APPROVED BY | SIGN | DATE |
| Site Quality Head |
Pre-Approval for Operation and Performance Qualification Protocol (Vendor Format)
| Instrument Name | |
| Instrument ID. No. | |
| Make & Model No. | |
| Department | |
| Ref. SOP. No. | |
| Equipment location | |
| Movable / Non Movable | |
| Group (A / B / C) | |
| Change Control No. | |
| Protocol No. & Rev. No. | |
| Effective Date | |
| Vendor Qualification Protocol No. / Rev. No. |
| REVIEWED BY | SIGN | DATE |
| Head – QC | ||
| Site Head Engineering | ||
| QA Person | ||
| Head-QA |
| APPROVED BY | SIGN | DATE |
| Site Quality Head |
DOCUMENT ASSESSMENT CHECKLIST
| Sr. No. | Title of OQ and PQ Content | Applicable (Yes / No) | Available (Yes / No / NA) |
| 01 | Instrument calibration verification | ||
| 02 | Verification of utilities | ||
| 03 | Identification of Standard procedure and other related documents | ||
| 04 | Verification of key functionality and Operating parameter | ||
| 05 | Verification of performance checks | ||
| 06 | Verification of safety feature / Interlock / Alarm | ||
| 07 | Verification power / Communication failure |
Acceptance Remark for OQ and PQ:
Remarks: Addendum to the OQ and PQ Qualification protocol shall be done to cover individual content if any of the above listed content, which is applicable and not covered in OQ and PQ Qualification protocol of the vendor.
Details of the Addendum to OQ and PQ Qualification protocol:
| Sr. No. | Document Title | Approval Date | Reason for Addendum |
Assessment Done by
| User Department Sign & Date | QC Head Sign & Date |
| Quality Assurance Sign & Date |
Reviewed by
Tracker for additional Addendum to OQ and PQ Qualification protocol:
| Sr. No. | Document Title | Approval Date | Reason for Addendum | Updated By |
Post- Approval for Operation and Performance Qualification Protocol (Vendor Format)
This is to certify that Operation and Performance Qualification of
Equipment Name: _________________________________________________
Equipment ID. No.: ______________________________________________
Computer System Validation (Software Validation) : [ ] Applicable [ ] Not Applicable
If Applicable;
Reference Protocol / Report No. : _____________________
CSV Final Approval Date : _________________
is approved and can be proceed for Calibration Qualification (as applicable) .
| QC Person | QC Head | QA Person | Head-QA | Site Quality Head |
Traceability Matrix
| Sr. No. | URS Point no. | Description of URS point | Qualification Document/ Test Number | Status | Remarks |
Acceptance Remark for Traceability Matrix:
| Done by | Checked by | Reviewed by |
| User Department Sign & Date | QC Head Sign & Date | Quality Assurance Sign & Date |
