Monthly Archives: May 2015

When the FDA Inspector visits your firm, What are the Chances of a Really Bad Outcome?

It’s generally nerve-wracking when the US Food and Drug Administration (FDA) shows up at your door for an inspection. Even if you’re confident that everything is in good shape around every corner. To ensure compliance with regulations, the FDA conducts … Continue reading

Posted in Drug regulatory and guidelines | Leave a comment

Protected: USCGMP Member List

There is no excerpt because this is a protected post.

Posted in Pharmaceutical and Biotechnological

Interview Questions for Pharmaceutical industry related jobs (QA,QC,Production,RA,f&d) for B.pharma /M.pharma (Part 8)

Requested By: for KVR SudhirOrganization: PharmaceuticalsCategory : Parenterals Questions A.     VIAL WASHING  MACHINE QUESTIONS 1. What is purpose of vial washing machine? Objective: Cleaning of Vial externally and internally to reduce the bio-burden. Note:  It is used as a primary … Continue reading

Posted in Pharmaceutical and Biotechnological | 5 Comments

HVAC Control and Monitoring System Validation

The control and monitoring systems are considered the core of the environmental control system. The final performance of the environmental control system can be evaluated only after these have been validated. PQ protocols covering this system, in general, include the … Continue reading

Posted in Air Handling System | 2 Comments