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?