Calibration vs Qualification
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The document presents a seminar on calibration and qualification of analytical instruments in the pharmaceutical field, outlining the need, importance, and processes involved in these practices. It categorizes instruments into three groups based on their qualification requirements and describes the phases of qualification: design, installation, operational, and performance. Overall, it emphasizes the significance of calibration and qualification for accurate and reliable measurements in pharmaceutical applications.
Calibration vs Qualification
- 1. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1 CALIBRATION vs QUALIFICATION A Seminar as a part of curricular requirement for M. Pharm I year I semester Presented by A.Siddartha Tharun Teja Reg. No. 20L81S0804 Department of Industrial Pharmacy Under the guidance/Mentorship of Dr. Hindustan Abdul Ahad M.Pharm Ph.D FAGE Professor & Head of Dept. of Industrial Pharmacy
- 2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2 • Calibration • Need for calibration • Importance of calibration • Qualification • Categories of Analytical Instruments. • Phases of Qualification • References Contents
- 3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3 • Calibration of an instrument is the process of determining its accuracy. • The process involves obtaining a reading from the instrument and measuring its variation from the reading obtained from a standard instrument. • Calibration of an instrument also involves adjusting its accuracy and precision. • Calibration achieves 2 main objectives— (a) It checks the accuracy of an instrument. (b) It determines the traceability of the measurement. Calibration
- 4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4 Need for Calibration Calibration can be done when •With a new instrument. •When a specified time period is elapsed. •When a specified usage (operating hours) has elapsed. •When an instrument has had a shock or vibration. •Sudden changes in weather. •Whenever observations appear questionable.
- 5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5 Importance of Calibration • When you regularly calibrate your instrument, you can eliminate drift in its budding stage before it affects your measurements. • Calibration helps in controlling errors and uncertainties to an acceptable levels. • It helps in improving accuracy of the instrument. • Finally in a single word, it allows pharmaceutical companies to have confidence in their results.
- 6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6 Qualification •It is the action of providing and documenting that equipment or ancillary systems are properly installed, work correctly, and actually leads to the expected results. •Qualification is a part of validation, but the individual qualification steps alone do not constitute process validation. •Qualification of analytical instrumentation is essential for accurate and precise measurement of analytical data.
- 7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7 Categories of Analytical Instruments •Users are establishing the level of qualification needed for an instrument. •On the basis of level, the instruments are categorized into three groups i.e., A, B, and C. •These categories should be determined by the user for their specific instrument or applications. •Depending upon the individual user requirements, the same instrument may appropriately fall into one group for one user and another group for another user.
- 8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8 Group A : •Group A includes standard equipment with no measurement capability or usual requirement for calibration, where manufacturer’s specification of basic functionality ids accepted. •Conformance of Group A equipment with user requirement may be verified and documented through visual observation of its operation. •Examples of equipment in this group includes Nitrogen Evaporators, Magnetic Stirrers, Microscopes etc.
- 9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9 Group B : •It includes standard equipment and instruments providing measured values as well as equipment controlling physical parameters that need calibration. •Conformance of Group B instruments or equipment to user requirements is determined according to the standard operating procedures for the instruments or equipment, and documented during IQ and OQ. •Examples of instruments are Balances, pH meters, Refractometers, Viscometers, Thermometers etc. •Examples of equipment are Ovens, Pumps, Water baths, Dilutors etc.
- 10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10 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 this instruments to user requirement is determined by specific function tests and performance tests. •Installing this instruments can be complicated undertaking and may require the assistant of specialists. •A full qualification process should apply to this instruments. •Examples of this type are Atomic Absorption Spectrometers, Differential Scanning Calorimeters, Dissolution Apparatus, HPLC, Mass Spectrometers etc.
- 11. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11 Phases of Qualification •Qualification of instruments is not a single, continuous process. •It results from many discrete activities. •These activities have been grouped into 4 phases. 1. Design Qualification (DQ). 2. Installation Qualification (IQ). 3. Operational Qualification (OQ). 4. Performance Qualification (PQ).
- 12. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12 1.Design Qualification (DQ) : •It is the documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose. •It should be performed when new equipment is being purchased, or when existing equipment is used for a new application. •It also serves as a precursor for defining the equipment installation qualification and operational qualification.
- 13. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13 2.Installation Qualification (IQ) : •Installation qualification is a documented collection of activities needed to install an instrument in the user’s environment. •IQ applies to a new, pre-owned or an existing onsite but not previously qualified instrument. •The activities and documentation associated with the IQ are as follows: System description. Utilities/Facility/Environment. Network and data storage. Assembly and verification. Installation verification.
- 14. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14 3.Operational Qualification (OQ) : After a successful IQ the instrument is ready for OQ testing. The OQ phase may consist of these test parameters. •Fixed Parameters : These tests measure the instrument’s non-changing, fixed parameters such as length, height, weight etc. •Secure Data Storage, Backup, and Archive : When required, user may check secured data handling, such as storage, backup, and archiving as per the written procedures. •Instrument Function Test : This can be done to verify that the instrument operates as intended by the manufacturer and required by the user.
- 15. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15 4.Performance Qualification (PQ) : •After the IQ and OQ have been performed, the instrument’s continued suitability for its intended use is proved through performance qualification. •It includes following parameters: 1. Performance Checks: Set up a test or series of tests to verify an acceptable performance of the instrument. PQ tests are performed routinely on a working instrument, not just only on a new instrument. PQ tests are typically based on its applications at the installed place.
- 16. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16 2. Preventive Maintenance and Repairs: When the instrument fails to meet specifications in PQ tests, it should require maintenance or repair. The relevant PQ tests are also performed after its repair or maintenance. 3. SOP and Log Book: Establish standard operating procedure for operation, calibration, and maintenance. Use a log book, binder, or electronic record to document each maintenance and calibration activity.
- 17. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17 References 1. Bansal, Surendra & Layloff, Thomas & Bush. Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach. AAPS PharmSciTech. 2004; 5. E22. 10.1208/pt050122. 2. Rohit Bhatia: Calibration and Qualification of Analytical Instruments. Health & Medicine, Slideshare, 2018. 3. Princy Agarwal: Pharmaceutical Calibration, Qualification and Validation. Education, Slideshare, 2017.
- 18. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO- DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18 Thank You