EMA consults on tackling cross-contamination at shared drug manufacturing facilities
This article was originally published in SRA
The European Medicines Agency is inviting feedback on a draft guideline that explains how companies that make different medicinal products at shared manufacturing facilities should review and evaluate pharmacological and toxicological data of individual products to tackle cross-contamination issues1.
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The European Medicines Agency on April 30 issued a
As more highly potent and highly toxic drugs are being developed, regulators are looking into risks posed by contamination of non-contact surfaces, yet until recently, there was scant guidance on how to assess these risks.
Aging plant in Worthing, UK, must either dedicate building solely to penicillin or undergo wrenching decontamination before US distribution of non-penicillin products could resume.