A new standard for bioburden testing

The USP has proposed a new standard for bioburden testing (USP chapter 1115). The main basis of the chapter is setting out a risk based approach to monitor and control a manufacturing facility for the processing of non-sterile products.

To examine the implications of the proposed chapter, and in a review of bioburden issues in general, Tim Sandle has written an article for the GMP Review.

The reference is:

Sandle, T. (2013). A new standard for bioburden testing: USP chapter in development, GMP Review, 12 (3): 10-12

For further details, please contact Tim Sandle

Posted by Tim Sandle