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Showing posts from February, 2020

Quality Control Interview Questions & Answers

Quality Control Interview Questions and Answers Question 1: What is the ultraviolet invisible spectroscopy range? Answer: UV spectroscopy range 200 to 400 nanometres visible spectroscopy range 400 nanometres to 800 nanometres. Question 2: What is the use of spectroscopy? Answer: Spectroscopy used for detecting the functional group, impurities, qualitative and quantitative analysis can be done.. Question 3: What is the difference between qualitative and quantitative analysis? Answer: Qualitative analysis to be identification of the compound or chemical based on their chemical absorption emission or physical properties. Eg. Melting point, boiling point. Quantitative analysis is estimation or determination of concentration or amount of the chemical compounds or components. Question 4: Explain the principle of ultraviolet spectroscopy? Answer: UV spectroscopy uses light in the UV part of electromagnetic spectrum. Over absorption spectra arises in which molecu

Question & Answer from OOS guideline USFDA

Question & Answer from OOS guideline USFDA Question number: 1) In which section of 21 CFR 211 it is written that I need to conduct an investigation if an OS test result is obtained ? Answer: Is an investigation is required by FDA regulation as mentioned in the section 211.192 Question Number: 2) What is the purpose of an OS investigation ? Answer: To determine the cause of the OS the result. Question number: 3) Who should investigate OOS ? Answer: Investigation should be done by both manufacturing companies as well as contract laboratories. Question number:4) Which part of CGMP regulation apply to laboratory operations? Answer: part 211 sub-part  I for laboratory controls and sub-part  J stands for records and reports Question number: 5 )Which section of CGMP regulations specify is that product failing to made established standard and other relevant quality control criteria will be rejected ? Answer: It is clearly written in the section 211.165(f)