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Pharmaceutical Interview Questions 5 blog contains questions about Q, S, E and M in the ICH, BPCR, cleaning validation, E, meaning of Q, raw material and packing material asked in pharma sector interview

41. What is the meaning of Q, S, E, and M in the ICH?
42. How many guidelines are present in Q & what are those, describe in detail?
43. How many types of raw material and packing material?
44. Define the Key raw material/ starting material & primary packing material?
45. What is cleaning validation?
46. What are the sampling techniques used in the cleaning validation?
47. What parameters considered during performance qualification of HVAC?
48. What are the contents in the BPCR?
49. What is OOT and define?
50. How will you prevent cross-contamination between two different products manufactured in the one production block?

41. What is the meaning of Q, S, E, and M in the ICH?

“Q” stands for Quality
“S” stands for Safety
“E” stands for Efficacy and
“M” stands for Multi dispensary

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42. How many guidelines are present in Q & what are those, describe in detail?

In Quality (Q), total 10 guidelines are present. Those are as follows:
1. Q1 - Stability
2. Q2 - Analytical Method validation
3. Q3 - Impurities
4. Q4 - Pharmacopoeia
5. Q5 - Biotechnological quality
6. Q6 - Specification
7. Q7 - Good Manufacturing Practice (GMP)
8. Q8 - Pharmaceutical Development
9. Q9 - Quality Risk Management
10. Q10 - Pharmaceutical Quality System
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43. How many types of raw material and packing material?

Raw materials are classified into two types. Those are as follows:
1. Key raw material
2. Other raw material
Packing materials are classified into two types. Those are as follows:
1. Primary Packing material
2. Secondary Packing material
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44. Define the Key raw material/ starting material & primary packing material?

Key raw material/starting material:
Starting material shall be defined as that which is
Incorporated as a significant structural fragment of the API / Drug Intermediate and
Having significant effect on the Quality and Yield of the product.
Starting material shall be identified in TDP.
Primary Packing material: Packing material, which come in direct contact with the
API/Intermediate is considered as Primary packing material.
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45. What is cleaning validation?

Cleaning validation is documented evidence that an approved cleaning procedure will provide equipment which is suitable for processing of pharmaceutical products or APIs.
Cleaning validation is the confirmation of reliable cleaning products so that the analytical monitoring may be omitted or reduced to a minimum in the routine phase.

It describes the validation of cleaning procedures for the removal of contaminants associated with the previous products, residues of cleaning agents as well as the control of potential microbial contaminants.
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46. What are the sampling techniques used in the cleaning validation?

Swab sampling:


Areas which are reasonably accessible & hardest to clean can be evaluated, leading to level of contamination or residue per gives surface area.

Rinse sampling:


Large areas or parts of equipment’s which could not be swabbed should be rinse sampled or directly extracted by solvent.
Tubes, nozzles, pipes or containers with surface those are not reasonably accessible for direct surface sampling have to be rinsed with solvent.
In addition, inaccessible areas of equipment that cannot be routinely disassembled can be evaluated.
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47. What parameters considered during performance qualification of HVAC?

The following parameters are to be considered during the performance qualification of HVAC:
1. Calibration test certificates of instruments
2. Training records of validation team
3. Pressure drop across the HEPA & fine filters
4. Air velocity measurement & calculation of Air changes
5. Integrity test of HEPA filter
6. Differential pressure test
7. Temperature & Relative Humidity test
8. Air flow direction test
9. Cleanliness class verification (Non-viable particle count)
10. Sound level test
11. Light level test
12. Air borne viable particle monitoring
13. Recovery Study
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48. What are the contents in the BPCR?

BPCR contains the following contents, but not limited:
1. Product Name
2. Stage
3. BPCR Document Number
4. MPCR Reference Number
5. Batch Number
6. Date of Manufacturing
7. Date of Expiry/Re-test
8. Batch release details
9. List of equipment’s used
10. List of raw materials & Quantity with UOM
11. General instructions, Control & Safety instructions
12. Detailed step wise written manufacturing procedures
13. Actual results record for critical process parameters
14. Identity of In-process & Laboratory test results
15. Signatures of person performing details along with supervising details
16. Description of Packaging details
17. Yield calculation
18. Representative of labels for intermediates / raw materials
19. Deviation details
20. Batch starting & completion date
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49. What is OOT and define?

“OOT” stands for Out Of Trend.

It means any test results obtained for a particular batch that is markedly different the results of the batches in a series obtained using a same validated method.

50. How will you prevent cross-contamination between two different products manufactured in the one production block?

By maintaining the proper pressure differential between the rooms with two Air handling units (if re-circulation) / one Air handling unit (if 100% fresh air)
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Thanks for reading - Pharmaceutical Interview Questions 5
Naitik Patel
Industrial Guide

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