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 val
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
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
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.
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.
