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Water for injection (WFI) generation system in Pharmaceutical industry l 21 basic and important Interview.
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Questions covered:
Q. What is Water for Injection (WFI), and why is it required in pharmaceutical manufacturing?
Q. How is WFI generated in pharmaceutical manufacturing facilities?
Q. What are the key quality attributes of WFI, and how are they ensured during the generation process?
Q. How is the bacterial endotoxin content in WFI controlled and monitored?
Q. What is the role of the conductivity test in assessing WFI quality?
Q. How is Total Organic Carbon (TOC) used to evaluate WFI quality?
Q. What are the various purification steps involved in the generation of WFI through distillation?
Q. How does reverse osmosis (RO) contribute to WFI production?
Q. What is the significance of the storage and distribution system for WFI?
Q. How is the microbial quality of WFI assured during the generation process?
Q. What is the typical sampling frequency for WFI testing, and what methods are used for microbial testing?
Q. How is the temperature of WFI maintained during storage and distribution?
Q. Can you explain the difference between Purified Water (PW) and WFI?
Q. How does the USP define the maximum allowable endotoxin content for WFI?
Q. What are the consequences of using non-compliant WFI in pharmaceutical manufacturing?
Q. How is the performance qualification (PQ) of a WFI generation system conducted?
Q. What are the regulatory requirements for WFI generation and distribution systems?
Q. How is the design of a WFI generation system influenced by risk assessment?
Q. What is the role of periodic requalification in maintaining the performance of a WFI generation system?
Q. How do you handle deviations or out-of-specification results in a WFI generation system?
Q. Explain the concept of Process Analytical Technology (PAT) and its application in WFI generation?
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