Cleaning manufacturing equipment to prevent cross contamination of pharmaceutical products is a fundamental aspect of GMPs. Validation of cleaning processes has been required within cGMP industries for a long time and is recognized as an important activity to establish that product cross contamination is controlled to ensure patient safety and product quality.
India and China represent nearly 40 percent of the world’s population, so their domestic markets for biologics alone represent a remarkable opportunity. However, currently, the opportunities for sales of biological therapeutics remain in more developed countries.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.
A look at making GMP training more engaging and meaningful — to benefit both the business and its personnel.
What specific skills do managers and supervisors need to be successful in a GMP environment?