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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3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
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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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[@apoorvjain4209]

Really good work 👏

[@PharmGrow]

Thanks 👍

[@rakeshrocky2126]

Thanks for this valuable information bro

[@PharmGrow]

Thanks for your comment

[@johnsondoeboy2772]

What would be a reason a parenteral device would use a hydrophobic filter? Isn’t all parenteral liquid based?

[@NileshPatil-el1kg]

Useful information

[@PharmGrow]

Thanks

[@venusankar-dh2kg]

😊🎉

[@PharmGrow]

Thanks

[@kushawahaboys2747]

What is present in pri &post nitrogen is vials dosing

[@PharmGrow]

Nitrogen purging is done to remove air / oxygen inside vials. This is done for oxygen sensitive products.

[@durgareddy3908]

What about Jishu hozen explain sir 👍👍

[@PharmGrow]

It refers to a method used in Total Peoductive Maintenance where operators take responsibility for the maintenance and care of their equipments to prevent breakdown and improve overall equipment effectiveness.

[@apaniyatra992]

Conductivity is wrong .1.3 not 0.25.pls correct.

[@PharmGrow]

Thanks for informing. I will correct👍