Difference between calibration & validation

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1. 1 TITLE : DIFFERENCE BETWEEN CALIBRATIOPN AND VALIDATION Presented By : NAME : SUSMITA GHOSH. COURSE : B.PHARM. YEAR : 4 th . SEM : 8 th ROLL : 19301920115 SUBJECT NAME : ADVANCE INSTRUMENTATION TECHNIQUES SUBJECT CODE : PT810C

2. INTRODUCTION The primary difference between Calibration and Validation is the documentation . Where calibration is just checking an apparatus’s accuracy in results , validation is written proof that the equipment , process , or system provides a consistent outcome. So one is done only to assure precision while the other needs to be adequately documented. 2

3. CALIBRATION 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 precision and accuracy so that its reading come in accordance with established standard. Calibration is important for justifying the process of qualification and validation. 3

4. NEED FOR CALIBRATION With a new instrument. When a specified time period elapsed. When a specified usages (operating hours) has elapsed. When an instrument has had a shock or vibration which potentially may have put it out of calibration. Whenever observation appear questionable. SCOPE OR PURPOSE OF CALIBRATION To make sure that the reading of equipment or instruments are consistent with measurement and display the correct reading every single time. To determine the accuracy , precision , reliability and deviation of the measurement produced by all the instrument. Ensuring that the industry standards , quality assurance benchmarks such as cGMP and government regulations are adhere to. 4

5. validation Validation is an integral part of Quality Assurance. It involves systematic study of systems , facilities and processes aimed to determining whether they perform their intended functions adequately and consistently as specified. A validation process is one which has been demonstrated to provide high degree of assurance that uniform batches will produce the product meet the required specifications. Validation is itself does not improve processes but confirms that the process have been properly developed and are run under control. 5

6. DEFINITION OF VALIDATION According To USFDA : “To establish documented evidence which provides a high degree of assurance that a specific process will consistantly produce a product meeting its pre-determined specifications and quality attributes.” Need of validation Validation is needed before introduction of a new method into routine use. Whenever the conditions change for which a method has been validated e.g. instrument with different characteristics. Whenever the method is changed and the change is outside the original scope of the method. 6

7. IMPORTANCE OF VALIDATION During validation knowledge of process increases. Assures the repeatability of the process. Decrease the risk of the manufacturing problem. Decrease the risk of failure in GMP. Decrease the expenses caused by failures in production. Scope of validation Validation requires an appropriate and sufficient infrastructure including : organizational , documentation , personnel and finance. Validation need involvement of management and quality assurance personnel. Validation program covers all the important areas of pharmaceutical processing. Like : Equipment Validation (Qualification). Process validation , Analytical validation , Cleaning validation , Facility and utility validation. etc. 7

8. CALIBRATION v/s VALIDATION Calibration and validation are two processes in manufacturing to guarantee the quality of the product or related apparatus. With the calibration the measurements are compared with an accepted reference measurement , to assure the considered measurements comply with the requirements. With the validation , the performance , quality and other operating parameters of a system are tested to verify that they comply with the requirements. 8

9. CALIBRATION v/s VALIDATION 9 CALIBRATION VALIDATION Calibration is a demonstration that , a particular instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements. In calibration performance of an instrument or device is comparing against a reference standard. Validation is a documented program that provides high degree of assurance that a specific process , equipment , method or system consistently produces a result meeting pre-determined acceptance criteria. No such reference standards are using in validation program.

10. CALIBRATION v/s VALIDATION 10 CALIBRATION Calibration ensures that instrument or measuring devices producing accurate results. Shall be performed periodically , to identify the ‘drift’ of the measuring device or equipment and make them accurate. Shall be performed as per calibration SOP. VALIDATION Validation provides documented evidence that a process , equipment , method or system produces consistent results. (in other words , it ensures that uniforms batches are produced.) No such requirements shall be performed when changes or modifications happen to the existing system or once revalidation period is reached. Shall be performed as per validation protocol.

11. ACKNOWLEDGEMENT I would like to express my gratitude to Mr . Biswanath Ghosh & Mr. Dipra Dastider , for their guidance and support. 11

12. REFERENCES 1. Jain N. K. “Pharmaceutical Product Development” , CBS Publishers & Distributors , 2008 , PP – (524-549 ) 2. Dr. Deepak , December 8,2017 , Difference between calibration and validation , 14.01.2023. 3. PharmaEducation , December 12,2020 , Difference between calibration and validation , 14.01.2023. https://pharmaeducation.net/difference-between-calibration-and-validation/ 12

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