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SOP for Laboratory Instrument Qualification

Standard Operating Procedure (SOP) for Laboratory Instrument Qualification including User Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Interim Qualification of Legacy Systems in Quality Control Laboratory.

Procedure for Laboratory Instrument Qualification

1.0      PURPOSE

    • The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for Qualification of laboratory instrument/ equipment.

2.0      SCOPE

    • This SOP shall be used as such for Qualification of Laboratory Instrument / Equipment in the Quality Control Department in the pharmaceutical manufacturing plant.

3.0      RESPONSIBILITY

    • The technical staff of IT / EM department :Instrument Qualification

    • Provide IT / Engineering support during Qualification activity.
    • Implement the backup policy for the electronic data generated by the instrument/equipment (Whenever required) as per the respective SOP of Electronic Data Management.
    • Ensure the data integrity and data security of the saved data and archived data.

    • Technical staff of Quality Control (QC) department:

    • Prepare the User Requirement Specification (URS).
    • Prepare the Qualification protocol and Assign the Protocol No.
    • Perform the activities as per protocol.
    • Prepare the SOP for cleaning, operations, and calibration of instruments/equipment.
    • Perform the interim Qualification and prepare the report as per attachment No. 4.

    • The technical staff of Quality Assurance (QA) :

    • To assign the URS No. & maintain the record on the URS log.
    • Verify the qualification status (stage wise) as per checklist (Refer Attachment No. 5).

    • Section Head / Manager QC :

    • Review the URS, Qualification protocol and Qualification Data.
    • Ensure that the backup, restoration, archival and retrieval procedure is followed as per SOP for laboratory data.

    • Head QC :

    • To approve the URS and Qualification protocol and report.
    • To ensure the training and implementation of this SOP.

    • Head QA :

    • To ensure the implementation of this SOP.
    • To approve the URS and Qualification protocol and report.

4.0      PROCEDURE

    • Category of Analytical Instruments :

    • 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 (but not limited to) (Nitrogen evaporators, Magnetic stirrers, Vortex mixers, Centrifuges, etc.)

    • 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.
    • The 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 Installation Qualification (IQ) and Operational Qualification (OQ).
    • Examples of instruments in this group are (but not limited to)
      • Balances,
      • Melting point apparatus,
      • Light microscopes,
      • pH meters,
      • Variable pipettes,
      • Refractometer,
      • Thermometers,
      • Titrators,
      • Viscometers,
      • Muffle furnaces,
      • Ovens,
      • Refrigerator-freezers,
      • Water baths,
      • Pumps,
      • Dilutors, etc.

    • Group C :

    • Group C includes instruments and computerized analytical systems, where user requirements for functionality, operational, and performance limits are specified for the analytical application.
    • The 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 SOP, should apply to these instruments.
    • Examples of instruments in this group are (but not limited to) the following:
    • Dissolution apparatus
    • High-performance liquid chromatography (HPLC)
    • Diode-array detectors
    • Gas chromatographs & IR spectrometers.

    • Preparation of User Requirement Specification :

    • User Requirement Specification (URS) : User requirement specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased.
    • Instrument / Equipment user department shall prepare the URS and send to the equipment manufacturer to make it as desired criteria.
    • It is required to clearly and precisely describe what the users want the manufacturing or process equipment to do, and distinguish between essential requirements and merely desirable features. There should be no ambiguity in the expectations of the users.
    • Prepare the URS as per SOP for User Requirement Specification (URS).

    • URS revision:

    • URS shall revise if there is a change in functionality (addition/Deletion) of the existing system.
    • The version of URS document shall be updated as described in the respective SOP for User Requirement Specification (URS)
    • URS revision history shall reflect all changes.

    • Procurement of Analytical Instrument / Equipment :

    • Analytical Instrument / Equipment shall be procured as per URS.
    • Purchase Order shall be released after getting confirmation on URS from the manufacturer / supplier.

    • Receipt of Analytical Instrument / Equipment :

    • At the time of new instrument receiving, check the documents as per Purchase Order (P.O.).
    • Avoid to open the packing by yourself, call the service engineer or manufacturer/supplier representative to open and verify with the packing list, spares, accessories etc. (wherever required)
    • Check the physical condition of the instrument/ equipment at the time of receiving. If there are any damages, intimate to the vendor in written on receipt document or through mail communication.
    • Ask the manufacturer for pre-installation requisite (Software, Hardware and utility requirements).
    • Arrange the accessories, utility and other requirements as per pre-installation requisite.
    • Ensure that the location, space requirement, environmental conditions, and electrical power supply are suitable.
    • Head QC or designee shall decide the location for the installation of the instrument/ equipment.
    • Raise the QMS document (Change Control and Request to allocate the instrument ID/Code).
    • Quality Assurance person shall allot the instrument/ equipment identification code.

    • Preparation of Qualification Protocol :

    • Raise the request to assign the Qualification Protocol no. as per Annexure 1.
    • Technical Staff of QC shall assign the Qualification Protocol no. and record the same as per Annexure 3.
    • Prepare the Qualification protocol as per Annexure no A.
      • Qualification protocol Number shall be assigned as follows :
      • QPI/XX/QC/YYY-ZZ
      • Where,
      • QPI = Qualification Protocol (Instrument)
      • XX  = Stand for Location/Block code (i.e. “BC” for Baddi Cephalosporin Block and “BP” for Baddi General Block)
      • QC  = Stand for Quality Control.
      • YYY = Stand for serial no. Protocol (i.e. 001,002,003…..) and
      • ZZ   = Stand for revision no. of Protocol (i.e. 01,02,03…..)
    • Qualification of Analytical Instrument / Equipment:
    • Check the physical condition of the instrument/ equipment at the time of receiving. If there are any damages, mention in the qualification report and intimate to the vendor.
    • Designated personnel shall carry out instrument/ equipment qualification with the help of the manufacturer’s instrument/ equipment engineer (if required).
    • QC Head or Designee shall verify the suitability of qualification documentation supplied by the instrument/ equipment vendor to meet the full range of testing according to or in parallel to the laid down requirement in Performance Qualification (PQ) in-house protocol/ procedure.
    • If the vendor PQ specification differs from PQ in-house protocol/procedure, in-house PQ shall be performed additionally after completion of vendor PQ.

    • Component of Analytical Instrument Qualification :

      • Design Qualification (DQ).
      • Installation Qualification (IQ).
      • Operation Qualification (OQ).
      • Performance Qualification (PQ).

    • Design Qualification (DQ) :

    • Design Qualification is the documented collection of activities that define the functional and operational specifications and intended purpose of the instrument.
    • DQ states what the laboratory wants the instrument to do and shows that the selected instrument is suitable.
    • DQ may be performed by the instrument manufacturer or the user.
    • It is expected that DQ requirements will be minimal for commercial, off-the-shelf instruments (Vendor Model no.).
    • Verification that the instrument specifications meet the desired functional requirements may suffice.
    • If instrument/ equipment is commercially available in the market and meets the intended purpose no need to prepare the design qualification protocol.
    • In case instrument/ equipment is commercially not available and instrument/ equipment required by the user for a specific purpose, the user needs to verify the design as per URS. (if required).

    • Design qualification of instrument/ equipment may cover the following contents but not limited. User can also change the protocol contents/specification as per requirements.

    • Instrument/ equipment : Name of instrument/ equipments.
    • Specifications: Features of instrument/equipment and acceptance criteria of instrument/ equipment.
    • Vendor: List of customers.
    • Vendor qualification: Selection of Vendor on the basis of previous interaction/by direct audit/by question-answer to the Vendor.
    • Verification of critical quality parameters like software validation, design validation or Compilation of ISO standards.
    • Installation Qualification :
    • IQ is the documented collection of necessary activities that an instrument is delivered as designed and specified, is properly installed in the selected environment.
    • Installation qualification shall be done by vendor / qualified Personnel, using vendor qualified or in-house approved protocol. (Refer A/RC/026/A-01-02)
    • Read the supplier instruction for installation and safety instructions before starting the installation qualification.
    • QC representative shall prepare IQ, OQ and PQ protocol for the instrument/ equipment using the manufacturer validation protocol and/or instrument/ equipment instruction manual.
    • If the vendor is providing the complete IQ, OQ, and PQ for the instrument/ equipment, that instrument/ equipment can be utilized for the intended use.
    • However, to prepare the in-house protocol and perform qualification studies shall depend on case to case basis and that decision shall be taken by Head QC or Designee.
    • The activities and the documentation associated with the IQ are as follows.
    • Instrument Delivery : Ensure that the instrument, software, manuals, supplies, and other instrument accessories arrive as specified in the URS/Packing list / Vendor documents.
    • Description : Document information about the instrument and all components including supplier, model, serial number, software version, etc.

    • Assembly and installation :

    • Assemble and install the instrument along with required accessories.
    • Perform the preliminary diagnostics and testing.

    • Software installation, Network and Data Storage :

    • Ensure that the Computer system is validated (In-house, as well as third party validation, is acceptable).
    • Establish the network connection through LAN (as applicable).
    • Apply the computer system policy as per SOP of Data integrity and Electronic Data Management.

    • Installation Verification :

    • Perform the initial diagnostics and testing of the instrument after installation.
    • During the qualification process, if the instrument/ equipment is found malfunctioning, fill the maintenance procedure (MP), which is given in the protocol. If instrument/equipment is working well during qualification, leave the MP part empty.
    • If major breakdown occurred in the instrument/ equipment or major part is replaced in the instrument/ equipment like motherboard, Processing board or detector, leave IQ part and fill the MP part and re-qualify the instrument/ equipment.
    • Complete IQ/OQ/PQ shall be done for critical instrument/equipment (Group C instruments) only like HPLC, GC, Dissolution, UV, etc.
    • The in-house qualification protocol shall contain detail steps to be performed for installation, operation and performance qualification. 
    • It shall also contain required supporting equipment details for the qualification and maintenance procedure.
    • After completion of IQ User shall prepare a draft SOP, after completion of OQ final SOP shall be prepared based on the qualification study for the regular usage and performance qualification.
    • PQ shall be perform by operating the instrument as per final SOP.
    • The in-house IQ, OQ and PQ protocol shall be prepared (if required). This protocol can be modified as per the instrument/ equipment requirement.

    • Operational Qualification :

    • OQ is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification testing in the selected environment.
    • OQ demonstrates fitness for the selected use, and should reflect the contents of the DQ document.
    • Testing activities in the OQ phase shall consist of the following test parameters (as applicable).
    • Fixed parameters: These tests measure the instrument’s non-changing parameters such as length, height, weight, voltage inputs, acceptable pressures, and loads.
    • If the manufacturer-supplied specifications for these parameters are acceptable, then no need to test these parameter.
    • Software functions: Where applicable, OQ testing shall include critical elements of the configured application software to show that the whole system works as intended.
    • Functions to test would be those applicable to data capture, analysis of data, and reporting results under actual conditions of use as well as security, access control, and audit trail.
    • Secure data storage, backup, and archiving: When applicable, test secure data handling, such as storage, backup, audit trails, and archiving according to written procedures.
    • Instrument function tests: Instrument functions shall tested to verify that the instrument operates as intended by the manufacturer/Supplier manual.
    • Software configuration and/or customization: Any configuration or customization of instrument software shall occur before the OQ and be documented.
    • Unless changes are needed for specific component tests, the OQ should be performed using the software configuration that will be used for routine analysis.

    • Performance Qualification :

    • PQ is the documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications, and is appropriate for the intended use.
    • The PQ verifies the fitness for purpose of the instrument under actual conditions of use.
    • After IQ and OQ have been performed, the instrument’s continued suitability for its intended use is demonstrated through continued PQ.
    • Prepare the protocol for PQ and Perform following activities (but not limited to).

    • Performance checks:

    • A test or series of tests to verify the acceptable performance of the instrument for its intended use.
    • The tests should be based on good science and reflect the general intended use of the instrument.
    • System suitability tests or quality control checks shall performed concurrently with the test samples can be used to demonstrate that the instrument is performing suitably.
    • When an instrument fails to meet PQ criteria or otherwise malfunctions, the cause of the failure must be investigated and appropriate action to be initiated.

    • Preventive maintenance and repairs:

    • Periodic preventive maintenance activities shall be done for instruments under Group C (but not limited to).
    • Document the preventive maintenance plans, including procedures and frequency as part of the IQ.
    • The instrument may require maintenance or repair. The relevant OQ or PQ test(s) should be repeated after the needed maintenance or repair to ensure that the instrument remains qualified.

    • List of instrument/ equipment’s/Standards used during qualification :

    • Give the detail of other instruments/equipment and standards used in the qualification of instrument/ equipment along with the detail like instrument/ equipment code no. and valid up to date.

    • Interim Qualification of Laboratory Instruments:

    • For the existing/legacy system review of the current qualification/ validation shall be performed as an interim qualification review.
    • The report shall be prepared to define further action based on the outcome.
    • As a corrective action addendum to the qualification/validation protocol shall be prepared and executed to mitigate the gap identified.
    • The validation activities which are not performed shall be addressed through interim qualification review and shall be performed.
    • Refer Attachment 4 for interim qualification review.
    • Frequency of Interim Qualification review shall be : 3 years ± 1 month or as and when required.

    • Requalification:

    • Requalification after the change shall be done to evaluate the impact of changes on the installation, operation, and performance of equipment.
    • Followings are the triggers of requalification (but not limited to):
      • After any major change in equipment design construction and material of fabrication.
      • Major breakdown maintenance on equipment or on the key parts of the utility system.
      • The major change in computer hardware and software system,
      • Relocation of Instrument /equipment (on the dismantling of equipment).
      • Qualification data lost.
      • Re-installation of software.
      • Any other specific requirement due to the change in regulatory guidelines.
    • When the instrument/ equipment is shifted from one laboratory (Change in premises) to another laboratory, re-qualification (IQ, OQ, and PQ) shall be performed.
    • When the instrument/ equipment is shifted within the laboratory premises (one room to another room), Instrument re-qualification is not required, in-house calibration is required.
    • Change control shall be established to control changes to the instrument configuration, including firmware and software. And requalification shall be performed for the same. (Based on the outcome of Risk and Impact assessment)

    • Content of Instrument Qualification Record :

    • The following shall be content and sequence of Analytical Instrument Qualification Record but not limited to.. (as applicable)
      • Index
      • User Requirement Specification (URS)
      • Purchase Order (PO) copy.
      • Receipt / Challan copy.
      • Instrument Certificates (provided by the manufacturer)
      • Training Certificate of Service Engineer / Technical person.
      • Design Qualification protocol / Manufacturer declaration.
      • Qualification Protocol
      • Installation Qualification Protocol and Report
      • Operational Qualification Protocol and Report
      • Performance Qualification Protocol and Report
      • In-house PQ Protocol / Report
      • Traceability Certificates (Device / instrument used darning qualification).
      • Analytical Raw Data
      • Others (if any)

5.0      REFERENCES FOR INSTRUMENT QUALIFICATION SOP :

    • SOP for User Requirement Specification (URS)
    • Validation Master Plan (Current Version)

6.0      ABBREVIATIONS AND DEFINITIONS

    • GC:  Gas Chromatography
    • IQ:   Installation Qualification.
    • OQ:   Operational Qualification.
    • PQ:  Performance Qualification.
    • DQ:  Design Qualification.
    • LAN:   Local Area Network
    • MP:   Maintenance procedure
    • SOP:  Standard Operating Procedure
    • IT:  Information Technology
    • EM :  Engineering & Maintenance
    • URS:  User Requirement Specification

7.0      ATTACHMENTS FOR INSTRUMENT QUALIFICATION SOP :

Annexer 1: Guideline for Preparation of Qualification Protocol

Index
Sr. No Description Page No
1. Protocol approval
2. Purpose,Scope and Qualification process
3. References
4. Responsibilities
5. Definition of terms
6. Training Record

 

Installation Qualification
7. Identification of performers/reviewers
8. Instrument/ Equipment details and specification
9. Installation check list, Calibration of sensors etc.
10. Installation requirements
11. Initialization test
12. Incident, Conclusion

 

Operational Qualification
13. Identification of performers/reviewers
14. Operational  requirements
15. Incident, Conclusion

 

Maintenance procedure
16. Identification of performers/Reviewers
17. Identification of system components
18. Maintenance log
19. Incident, Conclusion

 

Performance Qualification
20. Identification of performers/reviewers
21. Challenging the entire range and preciseness
22. Observation table
23. Incident, Conclusion

 

Attachment 1:  Request to Assign Qualification Protocol Number

Make the table with the following contents :

    • Concern Department
    • Initiated By (Name)
    • Name of equipment/ Instrument
    • Identification code
    • Reason / Justification
    • Initiating Department / Section
    • Initiated By (Sign. / Date)
    • Comments: Approved / Reject (By Head QC)
    • Qualification Protocol No. Allotted
    • Qualification Protocol No. Allotted by (Sign. / Date)
    • Protocol No.  Received by (Sign. / Date)

 

Attachment 2: Analytical Instrument Qualification Protocol Number Assigning Register

Make the Logbook with the following columns…

    • Sr. No.
    • Date
    • Instrument / Equipment Name
    • Identification code
    • Make
    • Model
    • Qualification Protocol No.
    • Assigned By
    • Remarks

Attachment 3: Interim Qualification Review Checklist.

Make the Checklist with the following checkpoints…

  • Instrument / Equipment/System Details :
    • Instrument / Equipment / Software Name
    • Make / Model
    • Instrument / Equipment ID/Code
    • Initial Qualification done on
  • Qualification Data Review :
    • User Requirement Specification (URS)
    • Instrument Certificates
    • Training Certificate of Service Personnel
    • Design Qualification (DQ)
    • Copy of Change Control / CCP No.
    • Qualification Protocol
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • In-House PQ / Calibration
    • Third-Party Calibration / External Calibration Report
    • Traceability Certificates
    • Service Report / Commissioning Report
    • Attachments / Others (if any)
  • Conclusion
    • Based on the review & evaluation of Qualification Documents / Records, the re-validation/Qualification of equipment/ system is – (Tick √ wherever applicable)
      • Not Required (   )
      • Required. The following activities as per action plans shall be done during the re-validation / Qualification of Instrument / Equipment / software.    (   ).
  • Action Plan :
Document / Activity Action Plan Responsibility Target Completion Date

Remarks
       

 

Attachment 4:Qualification Activity / Documentation Checklist.

  • Stage I (Below checkpoints to be verified prior to Installation Qualification)
    • Checkpoints
    • URS availability?
    • Purchase Order availability?
    • The Instrument / Equipment ID issued?  if yes, ID No. : _________
    • Is Change Control Initiated / Approved?  Ref CCP No. : ________
    • Checklist for pre-installation requisite fulfilled?
    • Is the Approved Installation protocol available?
    • Is the Service Engineer / Vendor training certificate available?
    • Remarks :________________________________________________
  • Stage II : (Below checkpoints to be verified prior to Operation Qualification)
    • Checkpoints
    • Availability of the User Manual ?
    • Draft SOP for Operation / Calibration Available?
    • Qualification Protocol executed/filled till the Installation part?
  • Stage III : (Below checkpoints to be verified prior to PerformanceQualification)
    • Approved SOP for Operation / Calibration Available?
    • Qualification Protocol executed/filled till the Operation Qualification part?
    • Approved protocol (if applicable) for Performance Qualification available?
  • Stage IV: (Below checkpoints to be verified prior to release for routine use)
    • The Performance Qualification Report satisfactory?
    • Is Qualification Report Compiled?
    • Creation of User Group / User created (where applicable)?
    • Change Control and Risk Assessment report completed/closed?
    • Operational training/demonstration imparted?

 

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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