Risk-Based Contamination Limits Suggested For Highly Potent Drugs
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.
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The European Commission has made a raft of revisions to its good manufacturing practice (GMP) guideline that deals with basic requirements for medicinal products.
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.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.