Instrumental method of analysis......pptx

Details of calibration and validation

1. Calibration and validation of Gas Chromatography Presented by , Manish Kumar Dalui B. Pharm , 8 th Semester 2023-2024 Subject: Advance Instrumentation Technique Sub Code: PT-810 c Roll No. 15901920079 Reg. No. -201590201910024 Of 2020-21 CALCUTTA INSITUTE OF PHARAMACEUTICAL TEACHOLOGY & A.H.S

2. CONTENT Definition of calibration and validation Difference between calibration and validation Calibration of Gas chromatography References

3. Definition of calibration & validation Validation definition as per ICH : The ICH’s guideline entitled text on validation of analytical procedures (ICH Q2A) which presents a discussion of the characteristics that should be considered during the validation of analytical procedures. Validation of analytical method may be defined as the process by which it is established by laboratory studies that the performance characteristics of the method meet the requirements for the intended analytical preparations .

4. Calibration definition as per ICH : Calibration is the set of operation that establish under specified condition the relationship between values indicated by a measuring instrument, a measuring system or values presented by a material measure and corresponding known values of measurement. Calibration cannot be Complete with out understanding of traceability in above definition the known values of measurement refer to a standard. This standard must have relationship with the calibration.

5. Difference between calibration and validation: Calibration validation 1. Calibration ensures That instrument or measuring devices producing accurate result. Validation Provides documented evidence that a process equipment method or system produces consistent result. 2. Shall be performed periodically to Identify the ‘drift’ of the measuring devices or equipment and make them accurate. No such requirement shall be performed when changes or modification happen to the existing system or once revalidation period is reached. 3. Shall be performed as per calibration SOP. Shall be performed as per validation protocol.

6. Calibration of gas chromatography Calibration of carrier gas flow setting: Touch on tool that on right hand side corner on screen of the instrument by using stick provided with instrument., Select option utilities. Later on column flow calculation. Enter column length diameter flow and column oven temperature; It will display required to set by or carriers pressure knob. Calibration of common oven temperature : Where Goggle and gloves while handling class wool. Insert the calibrated digital thermometer from top side by piercing glass wool. Now set column oven temperature on GC to 50 degree celcius . Allow to Stabilize the set temperature for 5 min and record the temperature on the digital thermometer at respective temperature.

7. References College Analytical Chemistry, Himalaya PublishingHouse , 19th Edition (2011), By K.B. Baliga et al. Chapter 4 - Optical Methods, Pages: 135-148. Raposo F. Evaluation of analytical calibration based on least-squares linear regression for instrumental techniques: A tutorial review. TrAC Trends in Analytical Chemistry. 2016;100(77):167-85.

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