Thursday, 21 July 2016

Managing Regulatory Inspections


When it comes to being prepared for an inspection from a regulatory authority, the combination of practice and preparation will often make the difference between success and failure.

Pharmaceutical Manufacturing are hosting a useful article by Joachim del Boca on regulatory inspections.

Here is an extract:

“Regulatory agencies are increasing their vigilance on the (bio-)pharmaceutical industry with greater scrutiny placed upon aseptic manufacturing facilities. Perhaps one of the most significant changes in this attentiveness has been in the area of data integrity. A recent increase in the number of incidents where a company’s data was falsified or poorly documented has led to new regulations.”

The article can be accessed here.

Posted by Dr. Tim Sandle