Qualification of UV Visible Spectroscopy-1.pptx

Presentation on Validation of uv visible spectroscopy

1. Mahatma   Gandhi   Vidyamandir’s   Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Pharmaceutical Validation Prepared By Guided by Miss. Punam Uttam Borde Miss. Harshda Patil Mam Roll No: 37 Presentation on QUALIFACTION OF UV SPECTROMETER 1

2. Vision To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process’ Mission: Impart high quality education to graduates Contribute to all spheres of professional activities Uphold human values and ethics Nature them into globally competent professional

3. Content: Introduction Qualification of uv spectroscopy DQ IQ PQ OQ References

4. Introduction: Validation: Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. It is a requirement for Good Manufacturing Practices and other regulatory requirements.

5. Calibration: Calibration is a necessary component to ensure of the authenticity of Qualification and Validation. Calibration is a process that demonstrates a particular instrument or device produces results within specified limits, as compared to those produced by a definite standard over an appropriate range of measurements .

6. Qualification Action of proving and documenting that any equipment, utilities, and systems actually and consistently leads to the expected results. Qualification should be completed before process validation is performed. Type of Qualification Design qualification(DQ) Installation qualification(IQ) Operational qualification(OQ) Performance qualification(PQ)

7. Design Qualification: Documented evidence which shows that the plant design agrees with the design specifications of the customer. Installation Qualification: Written evidence is given that allparts of equipment are installed according to the equipment supplier's and purchase specifications. Operational qualification: Documented evidence which showsthat all parts of the plant and equipment work within their specifications and process parameters. Performance Qualification: Provides documented evidence that all parts of a plant and other processes produce products of specified quality under conditions of normal production for a longer period of time

8. Qualification of UV Spectrophotometer: UV Visible spectroscopy is concerned with ultra violet and visible regions ranges from 200-780 nm Ultraviolet-visible (UV-Vis) spectrophotometry is a technique used to measure light absorbance across the ultraviolet and visible ranges of the electromagnetic spectrum. • When incident light strikes matter it can either be absorbed, reflected, or transmitted • The absorbance of radiation in the UV-Vis range causes atomic excitation, which refers to the transition of molecules from a low-energy ground state to an excited state

9. Design qualification: Documented evidence which shows that the plant design agrees with the design specifications of the customer.

10. Installation Qualification IQ is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified, and is properly installed in the selected environment, and that this environment is suitable for the instrument. According to USP, the IQ requirements provide evidence that the hardware and software are properly installed in the desired location. While the UV instrument was shipped after the precise adjustment and inspection at the factory, it is recommended to install according to the following procedures so as to provide its optimum performance and to meet the user’s demands.

11. Installation site to be… Room temperature during use of 15 to 35 °C. Out of direct sunlight. No strong vibration or continuous weak vibration. No strong magnetic fields or electromagnetic fields. Humidity of 45 to 80%. No corrosive gases or organic or inorganic gases with absorptivity in the ultraviolet range. Small amount of dust.

12. Operational Qualification: OQ is the documented collection of activities necessary to demonstrate that an instrument will function according to its operational specification in the selected environment. Following are the test performed during Operational Qualification for UV Spectrophotometer Wavelength Accuracy Control of Absorbance Limit of Stray Light Resolution Noise Stability

13. Performance qualification: Performance of instrument may change gradually over time because of normal wear of parts, failure or change of its components. The purpose of the PQ is to provide evidence that instrument is fit for its routine use Generally, performance of spectrophotometer measurements are performed under identical conditions for the test specimen and the reference substance (e.g. USP Reference Standard)

14. Refernces : Gouthami B, Venkateshwarlu G, Venkateshwarlu P. Calibration and Validation of HPLC, GC and UV-VIS Spectroscopy. Int J Mdrn chem Appl Sci. 2014,1(4);27-34Ultraviolet-Visible Spectroscopy. https://hmc.usp.org/sites/default/files/documents/HMC/GCs- Pdfs/c857.pdf [Accessed on 2019 Feb 18].Calibration of UV/Visible Spectroscopy. https://www.pharmaguideline.com/2010/05/calibration-of-uv-visible.html [Accessed on 2019 Feb 18].

15. Thank you