Pharmaceutical Technology Europe-12-01-2010

What are the current expectations for cleanroom operations? And are these realistic?

A review of warning letters from the last 10 years relating specifically to cleanrooms has indicated several concerns with the appropriateness of cleanroom design - primarily regarding air flow and laminarity.

Biotech has had a profound impact on the pharma industry by helping to develop new medicines that treat patients more effectively; however, despite its achievements, it hasn't made a significant difference to the number of new treatments reaching the market.

A European-wide awareness initiative hopes to tackle the issue of antibiotic over-prescription, but industry must also be encouraged to make further investments.

So 2010 is nearly over and what a year it's been for our industry.

With the increasing need for businesses to reduce costs and demonstrate value, there is a requirement to look at all aspects of bio/pharma drug development and manufacturing to achieve efficiency improvements.

Contamination in all its forms should be identified and reduced whenever and wherever possible.

A case study describes how a software control system can manage training needs across an international company and improve GMP compliance.