SOP FOR LABORATORY INSTRUMENT QUALIFICATION
Objective: To lay down the procedure for Qualification of laboratory instrument / equipment.
Scope: This procedure is applicable for the qualification of laboratory instrument /equipment in Quality Control Lab.
Responsibility: IT person shall be responsible to provide IT support and implement the data backup policy for electronic data generated by the instrument / equipment as per the respective SOP on electronic data management.
Engineering person shall be responsible to provide Engineering support
QC Officer and above shall be responsible for preparation of the URS (User Requirement Specifications) prepare the qualification protocol and perform the activities as per approved protocol.
Executive and above shall be responsible for Reviewed by / Checked by of URS and Protocol.
Head QC and QA shall approve the URS and qualification protocol and reports.
Accountability: QC Head shall be accountable for implementation of SOP.
Procedure:
Category of Analytical Instruments
Group A: Group A includes standard equipment with no measurement capability or no 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, pH meters, Variable pipettes, Refractometer, Thermometers, Titrators, Osmometer, Muffle furnaces, Ovens, Refrigerator, Water baths, Pumps, 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:
HPLC (High-performance liquid chromatography), UV-Spectrophotometer, 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 submit it to the manufacturer/supplier.
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).
Numbering System of User Requirement Specification (URS): The User requirement specification (URS) number shall be assigned as follows: URS /YYY
Where, URS = User requirement specification
YYY = Stand for of instrument/equipment ID.
For example, if URS prepared for HPLC having instrument ID: QCD/FF/HPL-05, then URS No. is URS/ QCD/FF/HPL-05.
Preparation of User requirement specification (URS) as per annexure –I.
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.).
Do not 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 writing through the receipt document or email.
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.
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): Design Qualification is the documented collection of activities that define the functional and operational specification 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 be sufficient.
If instrument/ equipment is commercially available in the market and meets the intended purpose, there is no need to prepare a 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.
Numbering System of Design Qualification: Design Qualification number shall be assigned as follows: DQP/YYY
Where, DQP = Design Qualification Protocol
YYY = Stand for of instrument/equipment ID.
For example, if DQ prepared for HPLC having instrument ID: QCD/FF/HPL-05, then Design Qualification Protocol.
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
Read the supplier instruction for installation and safety instructions before starting the installation qualification.
QC reviewer and his/her designee shall review DQ, IQ, OQ protocol and report.
PQ protocol for the instrument/ equipment preparation done by using the manufacturer validation protocol and/or instrument/ equipment instruction manual by Quality control officer & above.
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.
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 performed 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.
Numbering System of Installation Qualification: Installation Qualification number shall be assigned as follows: IQP /YYY
Where, IQP = Installation Qualification Protocol.
YYY = Stand for of instrument/equipment ID.
For example, if IQ prepared for HPLC having instrument ID: QCD/FF/HPL-05, then Installation Qualification Protocol.
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 non-changing parameters of the instrument 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 parameters.
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 be 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.
Numbering System of Operational Qualification: Operational Qualification number shall be assigned as follows: OQP /YYY
Where, OQP = Operational Qualification Protocol.
YYY = Stand for of instrument/equipment ID.
For example, if OQP prepared for HPLC having instrument ID: QCD/FF/HPL-05, then Operation Qualification Protocol.
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).
Preparation of Performance Qualification Protocol: Prepare the Performance Qualification protocol as per Annexure no-1. Performance Qualification Protocol Number shall be assigned as follows: PQP/YYY
Where, PQP = Performance Qualification Protocol
YYY = Stand for of instrument/equipment ID.
For example, if Performance prepared for HPLC having instrument ID: QCD/FF/HPL-05, then Performance Qualification.
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 be 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.
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; however in-house calibration shall be required.
Change control shall be established to control changes to the instrument configuration, including firmware software and Re-Qualification shall be performed for the same. (Based on the outcome of Risk and Impact assessment).
Forms and Records:
Annexure – I : User requirement specification(URS)
Annexure – II :Performance qualification protocol / report
Annexure – III : Checklist for DQ
Annexure – IV : Checklist for IQ
Annexure – V : Checklist for PQ
References: USP General Chapter <1058>.