Interview Questions for Quality Control / Assurance in Pharmaceuticals

To prepare for an interview a mock interview can help a lot. It can improve your interview skills if practice is done. Following are the generally asked questions about pharmaceutical quality control and quality assurance interviews.
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 between vacuum pressure and vapor pressure?
5 In the stability testing, if a significant change occurs then what will be the action plan?
6 What do you mean by MKT (Mean Kinetic Temperature) in the stability?
7 What are the stability zones and stability conditions?
8 What do you mean by Bracketing and Matrixing in the 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 the limit of cleaning validation?
14 What do you mean by MACO?
15 What is NOEL?

16 What is the 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 the limit of disintegration for Enteric coated tablets?
29 What should be the sampling point in the 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 the reference standard?
35 How impurity is analyzed in any tablet?
36 Why we use the placebo in the analysis?

37 What is the procedure to prepare the placebo?
38 What is the 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 excipients 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 is 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 photostability?
50 What is the pooled sample and why it is required in dissolution test?
51 Why we use disodium tartare for determination of factor in Karl Fischer titration?
52 What are closely monitor parameters in the 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 Tartrate?
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 a polarimeter lamp and IR lamp?
68 What is the difference between sonication and homogenization?
69 What is the difference between uniformity of content and content uniformity as the official test for all tablets?
70 What is the limit of uniformity of content as per USP?

71 How related substance method is developed for a new compound which is not official in the pharmacopeia?
72 If calibration of 12 bowl dissolution apparatus does not meet single-stage procedure, how can you precede calibration?
73 What is the capacity factor?
74 How will you calculate telling in any HPLC peak?
75 What do you mean by end-capping?
76 What is the wavelength of the polarimeter lamp?
77 Which gasses 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 the stationary phase?
81 What is hold time period for swab samples?