Tag:
Cross Contamination
Latest Headlines
Latest Headlines
Issue separates bio, small molecule CMOs
The importance of cross-contamination management to drug sponsors seeking to outsource production is greater when the drugs are biologics rather than small molecules. "Because biologics tend to be
Contamination concern rises about CMOs
Managing cross-contamination has increased the most among 19 factors of great importance to drug sponsors as they evaluate contract manufacturers. That's according to consultancy BioPlan Associates'
Draft gives non-penicillin ops guidance
The FDA expects manufacturers to treat sensitizing non-penicillin beta lactam antibiotics the same way they treat penicillin: using production facilities that are separate or isolated from those used
Cleanroom wipes to see improvements
Expect more features that promote ease of use and protect against cross-contamination in that intrepid soldier of drug production, the wipe. Manufacturers are also executing on promises of
Guide gives template for handling product cross contamination
An FDA/ISPE partnership aimed at applying science- and risk-based principles to multi-product facilities is expected to bear fruit in the next few months. The Baseline Guide for Risk-MaPP aims to
Warning cites API cross-contamination
Cross-contamination has tripped up API maker ZaCh Systems in France. The company was cited in an October warning letter for lacking procedures necessary to prevent cross-contamination. Beyond the
