Injectable Production / Sterile process in Pharmaceutical industry l Interview Question & answers

Injectable Production / Sterile manufacturing in Pharmaceutical industry l 30 Interview Question and answers
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1. QMS - Quality Management System in Pharmaceutical industry :    • QMS - Quality Management System in Ph...  
2. QA- Quality assurance in Pharmaceutical industry. :    • QA- Quality assurance in Pharmaceutic...  
3. QC - Quality Control in Pharmaceutical industry :    • QC - Quality Control in Pharmaceutica...  
4. OSD - Tablet Manufacturing in Pharmaceutical industry :    • OSD - Tablet Manufacturing in Pharmac...  
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Questions covered:
Q.: What is NVPC limit for GRADE A and Grade B ?
Q: What are the key steps involved in injection manufacturing ?
Q: Which are the important Qualification tests for Autoclave ?
Q: How are aseptic conditions maintained during injection manufacturing?
Q.: What is the difference between Sterile and Aseptic area ?
Q.: Why only 0.5 and 5 micron particles are measured for NVPC ?
Q: What is media fill testing, and why is it essential in injection manufacturing?
Q. : In which Area / class aseptic filling shall be carried out ?
Q: What are the critical environmental parameters monitored during injection manufacturing?
Q. : What are the important parameters of WFI as per USP?
Q: How is the container closure integrity of injections assessed?
Q: How is the container closure integrity of injections assessed?
Q.: Why nitrogen gas is used for purging and overlaying?
Q: What are the regulations and guidelines governing injection manufacturing?
Q. What are the basic types of filters used in pharmaceutical industry?
Q: How do you manage the risk of cross-contamination in multi-product facilities?
Q: Can you explain the role of container closure system integrity in injection manufacturing?
Q: What are the key considerations for selecting primary packaging materials for injectable products?
Q: How do you handle deviations and out-of-specification results during injection manufacturing?
Q: How do you ensure the stability of injectable products during manufacturing and storage?
Q. : Why three batches or three test cycles are considered for equipment Qualification ?
Q: What are the requirements for environmental monitoring in injection manufacturing facilities?
Q. : What is difference between Viable and Non-viable particle count ?
Q: How do you handle the disposal of rejected or expired injectable products?
Q. What are the significance of various zones for depyrogenation tunnel ?
Q.: Which are the commonly used methods for glove leak testing ?
Q. What is endotoxin and why depyrogentaion is important ?
Q. What are aseptic interventions ?
Q.: What is frequency for media fill ?
Q.: What are the important guidelines used for media fill ?
Q.: Why 0.2 micron filter is used for aseptic filtration in the pharmaceutical industry ?
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