Monthly Archives: August 2016

Regulatory guidace on Smoke study

Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditionsshould be conducted.   The studies should be well-documented with written conclusions.  Videotape or other recording mechanisms have been found to be useful … Continue reading

Posted in Pharmaceutical and Biotechnological | 1 Comment

Untouched area of Data Integrity in Pharmaceutical Industry

Now a days the topic “Data integrity and non compliance” is the hot topics. Lots of references available online that deals with the Data integrity issue. One of the major example am going to give today, that can be control by … Continue reading

Posted in audit, Drug regulatory and guidelines, News Updates | 1 Comment