Friday, August 26, 2016

Regulatory guidace on Smoke study

Air pattern or “smoke” studies demonstrating laminarity and sweeping action over and away from the product under dynamic conditions should be conducted.  

The studies should be well-documented with written conclusions.  Videotape or other recording mechanisms have been found to be useful in assessing airflow initially as well as facilitating evaluation of subsequent equipment configuration changes.  However, even successfully qualified systems can be compromised by poor personnel, operational, or maintenance practices.

Thursday, August 25, 2016

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 the management only.

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Complication in Pharma industry with stability issue and salary expectation in Indian scenario

Now a days the pattern of interview is very interesting in pharma industry. The main argument comes with following points, Exp...