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Quality Control Interview questions and answers II Pharmaceuticals
What are the pharma Interview Questions for quality control analyst?
Question 1- What is Dissolution?
Answer- Dissolution is nothing but the time required to dissolve the active drug substance into a medium in a given set of conditions.
Question 2- What is the Q value in dissolution?
Answer- Q value is a % of drug release.
Question 3- What is a stability study?
Answer- A stability study is a study of the drug substance or drug product that provides evidence that the drug product or drug substance is stable over a time period (Shelf life) under the influence of environmental factors such as temperature, humidity, and light.
Question 4- What is a stability chamber?
Answer- Stability chambers are the chambers to store the stability sample at different storage conditions to understand the impact of the different climatic conditions on the drug substance or drug product.
Question 5- What is a Significant change?
Answer- Significant change is a remarkable change in any physical or chemical condition of the drug product or pharmaceutical product.
Also Read:
Question 6- What is a significant change as per ICH?
Answer- According to ICH significant change in the drug product is defined as;
1. A 5% change in assay from the initial value; or failure to meet the acceptance criteria for potency when using biological or immunological procedures.
2. Any degradation product exceeding its acceptance criterion.
3. Failure to meet acceptance criteria for appearance, physical attributes, and functionality test, ( eg. color, phase separation, Resuspendibility, caking, hardness, dose delivery per actuation). However, some changes in physical attributes,( eg. softening, suppositories, melting of creams) may be expected under accelerated conditions.
4. Failure to meet acceptance criterion for pH.
5. Failure to meet the acceptance criteria for dissolution for 12 dosage units.
Question 7- What is the stability guideline as per ICH?
Answer- According to ICH, Q1 is a Stability guideline.
Question 8- Total how many ICH quality guidelines?
Answer- Total 14 quality guidelines as per ICH.
Question 9- What are the 14 ICH quality guidelines?
ICH Q5- Quality of Biotechnological Product
ICH Q7- Good Manufacturing Practices
ICH Q9- Quality Risk Management
ICH Q10- Pharmaceutical Quality System
ICH Q11- Development and Manufacture of drug substances
ICH Q13- Continuous Manufacturing of drug substances and drug products
ICH Q14- Analytical Procedure Development
Question 10- How many types of dissolution as per USP?
Answer- Total 7 types of dissolution as per USP.
Question 11- What are the 7 apparatus of dissolution as per USP?
Answer- Apparatus 1 – Basket
Apparatus 3 – Reciprocating cylinder (Not accepted by Japanese Pharmacopoeia)
Apparatus 4 – Flow through cell
Apparatus 5 – Paddle over a disc
Apparatus 6 – Rotating cylinder
Apparatus 7 – Reciprocating Disc
Question 12 – What is S1, S2, and S3 as per USP?
Answer- The dissolution test is performed in three stages that are S1, S2, and S3.
Question 13- What is dissolution acceptance criteria as per USP?
| Stage | No. of Units to be tested | Acceptance criteria |
| S1 | 6 | No unit is less than Q+5% |
| S2 | 6 | An average of 12 units (S1+S2) is equal to or greater than Q, and no unit is less than Q-15% |
| S3 | 12 | An average of 24 units (S1+S2+S3) is equal to or greater than Q, and not more than 2 units are less than Q-15% and no unit is less than Q-25% |
Interview Questions of Top Designations
FAQ
What are the questions asked in QC interview?
- Why do you want to work in quality control?
- How did you hear about quality control?
- When do you think you should start QA for a product?
- What are your greatest skills that relate to quality control?
- What are your short-term career goals ?
What is QC in pharma?
What are the tests performed in QC?
What type of questions are asked in pharma interview?
- Tell us about yourself.
- What are some of your strengths?
- What are some of your weaknesses?
- Why should we hire you for a role as a pharma QA?
- What are your salary expectations for this position?
- Why do you want to work with us?
- Can you tell me about some of your professional achievements?
