Sunday, March 27, 2016

Interview Question for QC & QA


  • 1 Can any deviation be changed into the change control?
  • 2 What is the difference between Humidity and Relative Humidity?
  • 3 What should be the temperature and humidity for the tablet compression?
  • 4 What is the difference of vacuum pressure and vapor pressure?
  • 5 In Stability testing if significant change occurs then what will be the action plan?
  • 6 What do you mean by MKT (Mean Kinetic Temperature) in stability?
  • 7 What are the stability zones and stability conditions?
  • 8 What do you mean by Bracketing and Matrixing in stability?
  • 9 How to select HPLC column for a particular product?
  • 10 What is the composition of a C18 column?
  • 11 What is validation, validation protocol and validation master plan?
  • 12 What is the process validation?
  • 13 What is limit of cleaning validation?
  • 14 What do you mean by MACO?
  • 15 What is NOEL?
  • 16 What is recovery factor?
  • 17 How much the minimum recovery should be in swab sampling?
  • 18 What is the acceptance criterion for detergent washing?
  • 19 What do you mean by LOD and water content?
  • 20 What is the difference between LOD and water content?
  • 21 What is the difference between Calibration & Validation?
  • 22 What is the difference between Validation & Qualification?
  • 23 What is the disintegration time of coated tablets?
  • 24 What is the limit for friability of tablets?
  • 25 What is disintegration time for dispersible tablets?
  • 26 What do you mean by Q+5 in dissolution?
  • 27 What is the disintegration time for Hard Gelatin Capsule?
  • 28 What is limit of disintegration for Enteric coated tablets?
  • 29 What should be the sampling point in dissolution test?
  • 30 Which will give more drug release paddle or basket in dissolution?
  • 31 Tablets of which drug are used in dissolution calibration?
  • 32 What is the difference between Drug Purity and Drug Potency?
  • 33 What should be the minimum limit of a working standard?
  • 34 What is the storage condition for reference standard?
  • 35 How impurity is analyzed in any tablet?
  • 36 Why we use the placebo in analysis?
  • 37 What is the procedure to prepare the placebo?
  • 38 What is difference between method validation and method verification?
  • 39 What is the technology transfer and how is it done?
  • 40 What are the steps for the sterilization procedure for Dry Powder injection facility (from Starting)?
  • 41 What exepients are used in dry powder injections?
  • 42 What should be the LOD of dry syrup?
  • 43 How can you fix the known and unknown impurity limit for any drug substance?
  • 44 What is the relative response factor in related substances?
  • 45 How do we choose HPLC or Gas chromatography for a sample analysis?
  • 46 Why 3X sampling plan are implemented in process validation?
  • 47 What is the difference between temporary change control and deviation?
  • 48 Why we use toluene for resolution in UV calibration?
  • 49 What is photo stability?
  • 50 What is pooled sample and why it is required in dissolution test?
  • 51 Why we use disodium tartare for determination of factor in karl ficher titration?
  • 52 What are closely monitor parameters in stability study?
  • 53 What are the limits for LOD and LOQ?
  • 54 Why should we not dispatch the reprocess material to export?
  • 55 What is the formula for KF standardization?
  • 56 How we fix the validity period of a volumetric solution and re-standardization due date?
  • 57 How quantitative stability studies are done?
  • 58 What do you mean by CAPA?
  • 59 In KF Standardization why we use Disodium Tartarate?
  • 60 What is the difference between Deviation and Out of Specification?
  • 61 What is the difference between mix-up and cross-contamination?
  • 62 What is GMP, cGMP and GLP?
  • 63 What is the calibration of HPLC?
  • 64 How polarimeter is calibrated?
  • 65 What is the difference between Analytical method validation and Analytical method transfer?
  • 66 How melting point apparatus is calibrated?
  • 67 What is the difference between polarimeter lamp and IR lamp?
  • 68 What is the difference between sonication and homozinization?
  • 69 What is the difference between uniformity of content and content uniformity as official test for all tablets?
  • 70 What is limit of uniformity of content as per USP?
  • 71 How related substance method is developed for new compound which is not official in the pharmacopeia?
  • 72 If calibration of 12 bowl dissolution apparatus does not meets single stage procedure, how can you precede calibration?
  • 73 What is capacity factor?
  • 74 How will you calculate telling in any HPLC peak?
  • 75 What do you mean by end capping?
  • 76 What is the wave length of polarimeter lamp?
  • 77 Which gases are used in gas chromatography?
  • 78 Which gas is used as a mobile phase in GC?
  • 79 What types of columns are used in GC?
  • 80 What is stationary phase?
  • 81 What is hold time period for swab samples?

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