SOP for performing Qualification of Equipment, Instrument and Area
1.0 OBJECTIVE:
To lay down the procedure for execution of Qualification study Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and other qualification study of Equipment/ Systems/ Instruments/ software/ area etc.
2.0 SCOPE:
The scope of the Standard Operating Procedure (SOP) covers about the preparation, pre approval, execution and post approval of Protocols and reports for Qualification of Equipment / Systems / Instruments / software / area etc at [Company name]
3.0 RESPONSIBILITY:
3.1 Engineering Department / Responsible department: To prepare IQ and OQ protocols, Team member for execution of IQ, OQ, PQ as and when required.
3.2 Functional Department: Support in preparation of protocol, Team member for IQ, OQ, and PQ performed in their department. Review of qualification report.
3.3 Quality Assurance Department: Approval of protocols, Team leader in performing IQ, OQ, and PQ. To prepare PQ protocols, in coordination with functional department.
4.0 PROCEDURE:
4.1 Any equipment / System or instrument purchased shall undergo installation, operational and performance qualification (if applicable) based on its application.
4.2 The Engineering department / Responsible department shall prepare the protocol for installation and operational qualification of the instrument / equipment / System with the help of the functional department head / designee. The same can be prepared by outside party (if applicable) for the functional department, which shall be approved by QA.
4.3 The QA person shall prepare the protocol for performance qualification of process equipment / System of functional department. The same shall be prepared by outside party (if applicable) for the functional department, which shall be approved by QA.
4.4 The head of the functional department shall support to arrange all the relevant information / documentation pertaining to each instrument / equipment / System from the manufacturer to support the qualification document and hand it over to engineering department.
4.5 Normally the content of the protocol for installation qualification, operational qualification and performance qualification shall be as per the annexure I, II & III respectively for the protocols prepared in house only and which may differ subject to the individual equipment and its working.
4.6 The content of the protocol for Re-qualification Protocol (RQP), Temperature Mapping and Performance Verification Protocol (PVP), study shall be as per the annexure IX, IV and VIII respectively for the protocols prepared in house only and which may differ subject to the individual equipment type and qualification requirements.
4.7 Each protocol shall bear the pre approval sheet at the start of the protocol, review sheet and certification after completion of the qualification study as per annexure V, VI and VII respectively.
4.8 Each protocol shall be identified with a number as described in the current version of SOP for “procedure for documents numbering”.
4.9 Protocols shall be approved by functional Department Head, User Department Head and Head of QA or his designee.
4.10 In case of IQ, OQ and PQ, the protocol shall be accompanied with the report, which shall be attached as a part of annexure or incorporated in protocol itself.
4.11 All the operations shall be performed, by putting sign. and date in checked by column.
4.12 All the operations shall be verified by second person normally functional department person with sign & date after completion of each operation in verified by column.
4.13 At the end of qualification activity report along with review sheet shall be approved.
4.14 Finally qualification study shall be certified by functional Department Head, User department Head and Head QA or by their designee.
4.15 The criteria for the Requalification will be as under but not limited to,
• In case of any major modification / changes done to the qualified equipment / System
• In case of inter / Intra location transfer of equipment / System or from one place to another.
• Replacement of the major component of equipment / System with a new component which may impact Safety, Identity, Strength Purity and Quality of product.
• Re-qualification governs through the criteria specified in qualification protocol or as per SOP for the subject.
4.16 Any changes in the equipment / System shall be handled through change control program
4.17 Equipment / System shall be re-qualified (Partial / Full) through supplementary protocol.
4.18 All Requalification protocol shall be prepared by functional department Head / designee with the help of User department and approved by QA Head / designee.
5. ANNEXURES:
Annexure – I Content for preparation of Installation qualification protocol
Annexure – II Content for preparation of Operation qualification protocol
Annexure – III Content for preparation of Performance qualification protocol
Annexure – IV Content for preparation of Temperature Mapping protocol
Annexure – V Content for pre approval of qualification study
Annexure – VI Content for review sheet of qualification study
Annexure – VII Content for certification of qualification study
Annexure – VIII Content for performance verification protocol
Annexure – IX Content for Requalification protocol
Annexure – I Installation Qualification of (Subject)
Name of the equipment
ID no
Location
Issue date
Supersedes
1. Index
Modification in the title / format can be done as per variation in equipment / systems and their type.
2. Objective
This section will give a brief overview of the objectives of the IQ.
3. Scope
This section will give a brief overview of the area of application of the IQ.
4. Qualification Team
This section will give list of department from which the people will be designated for the IQ.
5. Responsibility
This section gives the breif responsibility of the people involved in the IQ.
6. Requalification Criteria
This section will give the criteria for the requalification study to be performed for equipment / instrument.
7. System Description
This section will give a brief overview of the system and process description.
8. Equipment Specification
This section will give a brief description of each individual part of the equipment for example make, model, serial no. Dimension etc.
9. Equipment Identification
This section will give details about the purchase order, supplier, year of manufacturing, list of major component of equipment, etc.
10. Installation Qualification procedure
This section will give details about the critical component of the equipment, their specification , acceptance criteria along with checked by and verified by signature.
The equipment is also identified for its material of construction.
Enlisting and verifying the utilities provided for the running of equipment.
Identifying the equipment for its calibration status.
Verifying the equipment for installation in proper location and assembling,
Leveling and alignment, available drawings, standard operating procedure for
Operation cleaning and preventive maintenance,
Further enumerate if any deficiency or deviation observed during execution of the IQ protocols with proper justification.
11. Acceptance Criteria
IQ shall be considered valid only if all the test results are found to be acceptable .
12. Deficiency (If Any) And Corrective Action
This will include all the deviation and corrective action taken with proper justification and approval.
13. Summary:
This section will give details about the activity carried out during IQ study.
14. Conclusion: This part shall be summarized as under:
15. Report Approval: This part shall be summarized as under:
Done By
Checked By
Approved By
Annexure – II Operational Qualification of (Subject)
Name of the equipment:
ID no:
Location:
Issue Date:
Supersedes:
1. Index:
Normal modification in the title / format can be done as per variation in equipment/ systems and their type.
2. Objective:
This section will give a brief overview of the objectives of the OQ.
3. Scope:
This section will give a brief overview of the area of application of the OQ.
4. Qualification Team:
This section will give list of department from which the people will be designated for the OQ.
5. Responsibility:
This section gives the brief responsibility of the people involved in the OQ.
6. Re-qualification Criteria:
This section will give the criteria for the requalification study to be performed for equipment / instrument.
7. System Description:
This section will give a brief overview of the system and process description.
8.0 Operational Qualification Procedure:
This section contains the details of the draft SOP prepared for OQ. It also covers the procedure for operational checks performed for various components against the desired specification. Training record of the persons operating the equipment / instrument shall be attached.
Key functionality parameters shall be enumerated, checked and tested. Test particulars shall be listed with the specified function against which the observation and acceptance shall be written with checked by and verified by signature and date. The various safety features with the system description shall be observed and checked and verified for the acceptance. Sop shall be verified for the suitability. Any deficiency shall be approved with proper corrective action.
9.0 Acceptance Criteria
Operational Qualification shall be considered acceptable when all the conditions specified in various forms under section 9.0 have been met. Any deviation from the acceptance criteria of the specific checkpoint shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component.
10. Deficiency (if any) and corrective action:
This will include all the deviation and corrective action taken with proper justification and approval.
11. Summary
This section will give details about the activity carried out during OQ study.
12. Conclusion
13. Report Approval: This part shall be summarized as under:
Prepared By
Checked By
Approved By
Annexure – III Performance Qualification of (Subject)
Name of the equipment
ID no.
Location
Issue date
Supersedes
1. Index
Normal modification in the title / format can be done as per variation in equipment/ systems and their type.
2. Objective
This section will give a brief overview of the objectives of the PQ.
3. Scope
This section will give a brief overview of the area of application of the PQ.
4. Responsibility
This section gives the brief responsibility of the people involved in the PQ.
5. Qualification Team
This section will give list of department from which the people will be designated for the PQ.
6. Procedure
This gives the detailed procedure for evaluating the performance of the equipment / instrument. Any deviation observed during the verification study shall be recorded & investigated and shall be completed with proper justification. Different possible runs shall be taken as per the qualification methodology which shall be documented. Observation shall be recorded and checked and verified against the acceptance criteria.
7. Acceptance Criteria
Performance qualification should be considered acceptable when all the conditions Specified in various data sheets under point number 6.0 has been met.
Any deviation from the acceptance criteria of the specific check point should be reported and decision should be taken for the rejection, replacement or rectification of the component.
8. Re-Qualification Criteria:
This section will give the criteria for the requalification study to be performed for the subject.
9. Task Report
The report generated shall be attached along with the annexure or can be prepared as separate entity.
10. Deficiency (If Any) and Corrective Action
This will include all the deviation and corrective action taken with proper justification and approval.
11. Annexure:
This part will contains all the attachments and printouts, handouts generated during the qualification study.
12. Summary and conclusion:
This section will give details about the activity carried out during PQ study.
Report Approval: This part shall be summarized as under:
Done By
Checked By
Approved By
Annexure – IV Temperature Mapping Protocol for [Subject]
Name of the Area
Location
Issue date
Supersedes
1. Index
2. Objective:
This section will give a brief overview of the objectives of the temperature mapping study.
3. Scope:
This section will give a brief overview of the area of application of the temperature mapping study.
4. Qualification Team:
This section will give list of department from which the people will be designated for the temperature mapping study.
5. Responsibility
This section gives the brief responsibility of the people involved in the temperature mapping study.
6. Re Qualification Criteria
This section will give the criteria for the requalification study to be performed for the subject.
7. Procedure:
This gives the detailed procedure for installing the sensors with the drawings.
Any deviation observed during the verification study shall be recorded & investigated and shall be completed with proper justification. Different runs shall be taken as per the qualification methodology which then shall be documented. Location of the probes shall be identified with the probes number accompanied with the drawings showing the location of probes. Observation shall be recorded and checked and verified againts the acceptance criteria.
8. Acceptance Criteria
Study shall be considered acceptable when all the conditions Specified in various data sheets under point number 7.0 has been met.
Any deviation from the acceptance criteria of the specific check point should be reported and decision should be taken for the proper corrective action.
9. Task Report
The report generated shall be attached along with the annexure or can be prepared as separate identity.
10. Annexure
This part will contains all the attachments and printouts, handouts generated during the Mapping study.
11. Summary
This section will give details about the activity carried out during temperature mapping study.
12. Report Approval: This part shall be summarized as under:
Done By
Checked By
Approved By
Annexure V QUALIFCATION OF (Subject)
(Equipment Id)
PROTOCOL APPROVAL
Prepared by
Area Functional Department
User Department
Quality Assurance
Note: Normal modification in the title / format can be done as per variation in equipment
/area/system or on the basis of nature of study.
Annexure VI Review sheet
Validation protocol NO:
Functional department
Sign:
Date:
User department
Sign:
Date:
Quality Assurance
Sign:
Date:
Note: Normal modification in the title / format can be done as per variation in equipment
/area/system or on the basis of nature of study.
Annexure VII CERTIFICATE
This is to certify that the (Subject) having a ID no: (Equipment ID) has been qualified in accordance with the written protocols with no major deviations.
Comments (if any) :
Name Department
Signature
Date
Note: Normal modification in the title / format can be done as per variation in equipment/area/system or on the basis of nature of study.
Annexure – VIII Performance Verification Protocol
Name of the equipment
ID no
Location
Issue date
Supersedes
1. Index
2. Objective:
This section will give a brief overview of the objectives of the PVP.
3. Scope:
This section will give a brief overview of the area of application of the PVP.
4. Qualification Team:
This section will give list of department from which the people will be designated for the PVP.
5. Responsibility
This section gives the brief responsibility of the people involved in the PVP.
6. Procedure OF Performance verification :
This part will provide the detail procedure need to be followed for the execution of the protocol all along with test requirement and acceptance criteria for the individual test. Each test is checked by one person and verified by the second person. This study may enclose the details of Installation, Operational and Performance qualification activity.
7. Protocol Execution
This section will give the dates / duration of execution , name of the person executing the protocols and observing personnel.
8.0 Re verification Criteria
This section will give the criteria for the requalification study to be performed for equipment / instrument.
9.0 Acceptance Criteria
PVP shall be considered valid only if all the test results are found to be acceptable .
10.0 Task report
The report generated shall be attached as annexure with all printouts and handouts generated.
11. Deficiency (If Any) And Corrective Action
This will include all the deviation and corrective action taken with proper justification and approval.
12.0 Report Approval: This part shall be summarized as under:
Done By
Checked By
Approved By
Annexure – IX Re Qualification For (Subject)
Name of the equipment
ID no
Location
Issue date
Supersedes
1. Index
2. Introduction
This section will give the brief description about the system, equipment, instrument that is to be re-qualified for the intended use and the reason why as to activity is to be performed.
3. Objective:
This section will give a brief overview of the objectives of the RQP.
4. Scope
This section will give a brief overview of the area of application of the RQP.
5. Re Qualification Team
This section will give list of department from which the people will be designated for the RQP activity.
6. Responsibility
This section gives the brief responsibility of the people involved in the RQP.
7. Requalification Criteria
This section will give the criteria for the requalification study to be performed for equipment / instrument.
8. System Description
This section will give a brief overview of the system and process description.
9. Re Installation Qualification Procedure
This part include the schematic and flow diagram of the equipment, list of all component checked for the physical damage if any, utilities required, check the availability of the various drawings, manuals , relevant SOP’s, records of deviations, etc. Observation shall be recorded by one person and verified by other person.
10.0 Re Operational Qualification Procedure
This part include the verification that each of the component are working as per the requirement. All applicable sop available, operators are trained to perform the task, operators are trained to perform the task, record of deficiency if any etc. Test particulars shall be listed with the specified function against which the observation and acceptance shall be written with checked by and verified by signature and date.
11.0 Deficiency (If Any) And Corrective Action
This will include all the deviation and corrective action taken with proper justification and approval.
12.0 Acceptance Criteria
Re Qualification (Subject) shall be considered acceptable when all the conditions specified in various forms under section 9.0 & 10.0 have been met.
Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component.
13. Summary and Conclusion
14. Report Approval: This part shall be summarized as under:
Done By
Checked By
Approved By