Most Important Quality Control Interview Questions & Answers in Pharma
Q1. Which schedule of Drug & Cosmetics Act do we refer for Good laboratory practices?
Answer: Schedule L1
Q2. Why do we perform calibration of lab instruments?
Answer: Calibration of lab instruments is necessary to ensure the accuracy of instruments & to increase confidence on results get from measurement. Calibration is done by the measurement of known results of any reference standard.
Q3. Which edition of Indian pharmacopeia is in use currently?
Answer: 8th Edition (IP 2018)
Q4. Which ICH guideline helps to establish the shelf life of any pharmaceutical product?
Answer: Q1E: “Evaluation of stability data”
Q5. Difference between working standards & Reference standards?
Answer: Reference Standards: A reference standard is traceable & has a known quantity of drug substance which we get from regulatory bodies. These references are compendial (mentioned in IP/USP/BP/JP other pharmacopeia).
Working Standards: These are the highly characterized in house raw materials qualified against the reference standards & are use in place of the reference standard to perform your routine testing.
Q6. Specify the testing parameters for checking “Uniformity of dosage unit”?
Answer: Content uniformity and Weight Variation
Q7. How do we decide validity for volumetric solutions?
Answer: By doing stability study of that particular volumetric solution.
Q8. Why don’t we store NaOH solutions in glass bottles?
Answer: It is recommended to store Sodium hydroxide in plastic bottles instead of glass bottle because Sodium present in solution reacts with silica of glass bottle and form sodium silicate which affects purity of NaOH solution.
Q9. How do we check level of analytical balance?
Answer: By bubble leveler.
Q10.Why do we check dissolution of any drug product?
Answer: We perform dissolution to ensure the release rate of drug in the solution from the tablets. We have to check dissolution of any product because of use of excipients, & different in process activities (like granulation compression or coating) can affect the dissolution of drug from the tablet. Dissolution testing is done by use of six tablets.
Q11.What is the significant change in stability studies?
Answer: (i) A change 5% of more in assay from its initial value.
(ii)Any degradation product exceeding it acceptance criteria.
(iii) Fail in Appearance, physical test, pH, functionality test (phase separation, caking, hardness; dissolution.
(iv)As appropriate for the dosage form. Failure to meet the acceptance criteria for dissolution for 12 dosage units.
Q12. India lies under which stability zone?
Answer: Zone III (Hot & dry) & Zone IV b (Hot & higher humid).
Q13.How do we decide storage conditions for stability studies?
Answer: Nature of API used in formulation & the climatic zone of the country to which we are planning to market our product. To know more about the storage conditions, we can refer ICH guidelines stability studies which are accepted worldwide.
Q14.What is the difference between LOD & water content?
Answer: Water content is the quantity of water contained in a material & can be determined by the karl fischer titration method whereas LOD (loss on drying) is the quantity of all volatile matters including water content. It is determined by oven method.
Q15.What is the principle of HPLC?
Answer: The separation of HPLC is based on the distribution of sample between mobile and stationary phase. It depends upon the chemical structure of the sample. The components of the sample/analyte travels according to their affinities towards the stationary phase. The component which has more affinity towards absorbent (stationary phase) travels slow & retain more .Other components having less affinity towards absorbent (stationary phase) travels fast and retain for short time resulting elute first from stationary phase.
Q16.What is isocratic & gradient mode in HPLC operation?
Answer: In isocratic mode the mixture of mobile phase is consistent throughout the complete testing time whereas in gradient mode mixture of mobile phase changed during testing.
Q17.Which test we perform during calibration of UV Spectrometer?
Answer: Control of Absorbance
Limit of stray light
Q18.What is the difference between qualitative & quantitative analysis?
Answer: Qualitative analysis is performed to identify any chemical substance present in the sample while Quantitative analysis is done to evaluate the quantity/amount of that substance present in the sample.
Q19.Why do we use inert gases as mobile phase of carrier gas in the Gas chromatography?
Answer: We should use inert gases like helium, nitrogen or hydrogen as mobile phase or carrier gas in GC so that they do not react with sample components.