The interview is a challenge for the newbies as well as experienced candidates also, but here I am going to make you relax with respect to interview questions for quality control analysts for pharmaceutical.
Generally, the interviewer can check your knowledge or can check how you are capable to handle the situation while working on the shop floor or can be both reasons.
Here I am going to share pharma interview questions and answers for quality control analyst. Interview questions for fresher and experienced candidates may be:
The questions such as validation, Data integrity, Audit trail, significant change in stability, Alcoa Plus, ICH Guidelines, and many more.
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?
Answer-
ICH Q1- Stability
ICH Q2- Analytical Validation
ICH Q3- Impurity
ICH Q4- Pharmacopeia
ICH Q5- Quality of Biotechnological Product
ICH Q6- Specification
ICH Q7- Good Manufacturing Practices
ICH Q8- Pharmaceutical Development
ICH Q9- Quality Risk Management
ICH Q10- Pharmaceutical Quality System
ICH Q11- Development and Manufacture of drug substances
ICH Q12- Lifecycle Management
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 2 – Paddle
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?
Answer-
| 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 for quality control analyst for experienced
Question 14- What is Standard?
Answer- Standard is a known concentration solution.
Question 15- Why KBr used in IR?
Answer- 1. KBr is an inactive substance in IR range
2. KBr dipole moment is zero.
3. KBr is a temperature substance.
Question 16- Why is water not used in IR spectroscopy?
Answer- 1. Water is a strong polar solvent
2. In the IR region water shows two strong peaks
Question 17- What is Karl Fischer’s Principle?
Answer- The principle of Karl Fischer is “The titrimetric determination of water is based on a quantitative reaction of water with anhydrous Sulphur dioxide and iodine in the presence of a suitable base.”
Question 18- What is a correction?
Answer- Any repair, modification, adjustment, relabeling, destruction or inspection of a combination product without its physical removal from its point of use to some other location.
Question 19- What is recall?
Answer- Recall is an action to remove of specific products or batches of the product from the market.
Question 20- What is Mock recall?
Answer- Tracing specific batches of the product in the market to access the preparedness and efficacy of the distributor/carry and forwarding agents/global distribution center to get back details of the product in the shortest possible time.
Question 21- What is Quality Defects in Pharmaceutical?
Answer- Attributes of the medicinal product or component ( which may affect the quality, safety, and efficacy of the product) which are not in line with the approved product specifications.
Question 22- What is the full form of NDA, ANDA, and IND?
Answer- NDA- New Drug Application
ANDA- Abbreviated New Drug Application
IND- Investigational New Drug
Question 23- What is 21 CFR?
Answer- 21 CFR is Code of Federal Regulation Title 21 which represents “Food and Drugs”.
Question 24- What is Data Integrity in pharma?
Answer- Data integrity is the complete, consistent, and accuracy of the data throughout the lifecycle.
Question 25- What is Audit Trail?
Answer- Audit trail is nothing but secure, time-stamped, computer-generated electronic records that allows for reconstruction of the course of events relating to the creation, modification or deletion of electronic records. It is a chronological record of the activity that happened such as what, when, why, where etc.
Question 26- What is 21 CFR part 11?
Answer- FDA 21 CFR Part 11 represents “Electronic signature and Electronic Records”
Question 27- What is Validation?
Answer- Validation is a process of establishing documentary evidence demonstrating that a process, procedure or activity carried out in the testing and then production maintains the desired level of compliance at all stages.
OR
Process validation is defined as the collection and evaluation of data from the process design stage throughout the production, that establishes the scientific evidence that a process is capable to produce consistently delivering quality products.
Question 28- What are the types of Validation?
Answer- i. Prospective Validation
ii. Retrospective Validation
iii. Concurrent Validation
iv. Revalidation
Question 29- What are LOD and LOQ?
Answer- LOD is the lowest amount of analyte that can be detected but not necessarily quantitated.
LOQ- is the lowest amount of analyte detected and can be quantified at a defined level.
Question 30- What is Alcoa Plus?
Answer- Alcoa plus is an acronym of
A- Attributable
L- Legible
C- Contemporaneous
O- Original
A- Accurate
C- Complete
C- Consistent
E- Endurance
A- Available
Question 31- What is the Full form of ICH?
Answer- International Council for Harmonization of technical requirements for pharmaceuticals for human use.
The person who going to attain the interview for quality control can visit in between provided links or else can visit the Pharmabeejpro channel
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