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EQUIPMENT QUALIFICATION.pptx
- 1. Presented by T RamKumar Associate
- 2. Equipment qualificationis an essential step that companies need to perform in order to ensure that their products or services meet manufacturing and testing requirements and international standards.
- 3. Project Initiation master validationplan vendor management Equipment Qualification DQ(FAT, SAT), IQ, OQ, PQ
- 4. Validation ◦ Establishing documentedevidence that provides a high degree of assurance that a specific process will consistently provide a product meeting its predetermined specifications and quality attributes. Design Qualification ◦ The documented verification that the proposed design of the facilities, systems and equipment is suitable for the intended purpose or documented verification that the system design satisfies the requirements set forth in the URS.
- 5. Installation Qualification ◦ Theinstallation qualification is to demonstrate that all the critical components of the process equipment and support installations have been installed appropriately and are installed to the respective manufacturer’s or supplier’s requirements. Operational Qualification ◦ The OQ demonstrates whether a facility, process equipment and sub- systems are capable of consistently operating within established limits and tolerances by testing compliance with design requirements in URS.
- 6. Performance Qualification ◦Performance qualification are a collection of test cases used to verify that the system performs as expected under simulated real-world conditions. ◦ The documented collection of activities necessary to demonstrate that an instrument consistently performs according to the specifications defined by the user and is appropriate for the intended use. A series of tests are drawn to check the performance of the equipment.
- 8. The installationis done as per design specification URS. (IQ) The operation is as per the function and design specification in the URS. (OQ) The performance is as per the overall performance requirements specified in the URS. (PQ) FAT or SAT may be done based on risk assessment or criticality.
- 9. The impactof the equipment or system shall be assessed during risk assessment to determine those equipment or system that requires qualification and those equipments which do not require qualification. Based on risk assessment, the equipment can be categorized as 1. Direct impact 2. Indirect impact 3. No impact
- 10. Having directimpact on the product quality. E.g. Air quality, Material of construction, type of water, autoclave, CIP systems. Produces data, which is used to accept / reject in process material or product. E.g. Electronic Batch recording system. For process control systems such as PLC and SCADA or DCS.
- 11. Indirect systemsare those systems whose parts are connected to direct impact system or are playing an important role in direct impact systems. E. g. labelling machine, packing machine. No impact systems are those having no impact on product quality. E.g. conveyer belts, lifting and positioning devices.
- 12. category Need forQualification activity Qualification approach Direct Impact system Yes URS→DQ(FAT,SAT) → IQ→OQ→PQ Indirect Impact system Yes URS→DQ (FAT,SAT) → IQ & OQ, OQ& PQ (as applicable) No impact system No Good Engineering practice
- 13. User Requirementspecification shall be prepared by the user department in co- ordination with engineering based on previous performance and practical experience. URS should contain specifications of the system, documents required, safety design features, Equipment/ system description. The URS shall be approved by QA and the same shall be submitted.
- 14. After approval“Uncontrolled copy” shall be issued by QA to Engineering dept. for the identification of vendor who meets required specifications.
- 15. Design Qualificationis aimed to specify the equipment, system or facility is designed in accordance with the requirements of the user and good manufacturing practice(GMP) standards. DQ document shall be prepared, reviewed by the manufacturer. For feasibility the same shall be reviewed and approved by the user, Engineering and QA department.
- 16. Design qualificationshould contain 1. Equipment/system description 2. Equipment/system technical specification 3. Review/evaluation of vendor design against the URS 4. Deficiency sheet 5. Review inclusive of follow up action (if any) 6. It should cover all the necessary diagrams and layout 7. Desired material of construction 8. Location of control panel and electrical and utility requirement and their range. 9. After sign off, any changes made which is having direct or indirect impact can be handled through change control.
- 17. Factory AcceptanceTest is carried out by user, Engineering/projects and QA at the site of the vendor or by video conferencing through FAT document provided by the vendor. The evaluation includes ◦ Physical verification of dimensions ◦ Blower specifications ◦ Valves ◦ Safety requirements
- 18. Critical operationrequirement ◦ By simulation or conventional function ◦ Verification of documents ◦ Overall review / inspection ◦ Any modification from approved DQ, approved during FAT shall be incorporated in CC and considered during IQ. ◦ FAT document shall be filed in QA department.
- 19. Site acceptancetest shall be performed by User, Engineering and QA at site after the recipient of equipment/system in presence of vendor to ensure that the equipment / system is in good state, no components are damaged and meeting the design as per URS. It involves inspection of major or sub components in packed or unpacked condition, alignment checks of various components.
- 20. SAT alsoverifies the supporting utilities, pendants availability and adequacy etc at site. Points which are left out in FAT can be assessed in SAT test.
- 21. IQ documentshall be prepared by Engineering department in coordination with user and QA. IQ is carried out to ensure the premises supporting utilities and equipment have been built and installed in compliance with their approved design specification (DQ) and manufacturers manual and recommendations.
- 22. The documentsused for IQ should contain but not limited to ◦ Equipment description & identification ◦ List of reference documents & drawings ◦ Pre-requisites ◦ Checklist for inspection of Equipment on receipt ◦ List of Spares received ◦ Location suitability ◦ Verification of major components ◦ Verification of installation ◦ Identification of equipment / instrument for calibration and preventive maintenance.
- 23. ◦ Material ofconstruction ◦ Utilities/service connection checks ◦ Cleaning & passivation ◦ Manufacturer certificates ◦ Identification of product contact surfaces ◦ Deficiency sheet Any non compliance observed during Installation qualification shall be recorded.
- 24. OQ shallbe performed to verify that the equipment, instrument, utility and system, operates in accordance with design specification, manufacturer recommendations and cGMP requirements. Operational Qualification shall be prepared by user department in coordination with Engineering department and Quality assurance.
- 25. OQ shallbe prepared based on the DQ and manufacturers manual and recommendation. Operational testing to be done, whenever possible to challenge the system, to the limits of anticipated operating conditions. OQ shall be done without any load, if its not possible then loaded trials can be taken. It also should test the performance of the equipments components such as motors, blowers, sensors, functioning of interlocks, safety features.
- 26. The OQdocument should contain but not limited to ◦ Equipment operating principle ◦ Pre-requisites for operational qualification ◦ Methodology for operational qualification ◦ Calibration review of critical instruments like sensor, probes, gauges, recorders, air flow rates. ◦ Directions, pressure, temperature etc and referring to standard test instrument. ◦ Operational verification of equipment i.e operational testing as per process and system.
- 27. ◦ Verifications ofDraft SOPs & training. ◦ Testing of safety features and interlocks ◦ Power failure verification ◦ Validation of PLC ◦ Training to personnel for maintenance and operation ◦ Deficiency sheet ◦ When OQ documents compiled by vendor the documents shall be evaluated by the QA. ◦ The completion of successful OQ should allowed the finalization of SOPs and cleaning procedures, operator training and PM requirement.
- 28. PQ demonstratesthat how the equipment/system will perform when challenged under simulated or actual production conditions. A series of tests are designed to demonstrate that the equipment/system are capable to perform consistently and meet required specifications under routine production operations.
- 29. Performance qualificationdocument shall be prepared by QA (Validation) in coordination with user department and Engineering department. Performance qualification of the equipment shall be prepared based on User’s requirement and design qualification/ technical specification provided by the manufacturer.
- 30. PQ documentshould contain but not limited to ◦ Pre-requisites for PQ ◦ Methodology for performance qualification ◦ Performance verification tests ◦ Deficiency sheet Any significant changes it approved DQ/IQ/OQ/PQ documents during execution should be documented as a deviation and the same should be justified.
- 31. Conditional approvalfor proceeding to next phase of qualification can be given when certain acceptance criteria or deviation is not fully addressed, the same shall be addressed through documented evidence of no significant impact on the next activity. Qualification activities wherein location needs to be identified for placement of data loggers or sensors, the schematic layouts for sensor location should be mentioned in validation protocol for better clarity.
- 32. Requalification shallbe carried out in case ◦ Modification in the equipment which directly or indirectly affects the quality of the products processed in the equipment ◦ Relocation of the equipment ◦ Equipment up gradation ◦ Any other changes that deemed necessary for requalification through change management system.
- 33. Guideline –SOP.com ICH, Q9 Quality risk management