Particulate matter in parenteral drugs has been a known issue for over two centuries. Particular matter could come from any little thing that is involved in the process of making the drug product. Contaminants could come from the environment, packaging for the product, ingredients in the product, reactions of the formula and anything that could…
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Particles in Parenterals: 2019 Update
FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019? Visual inspection of parenteral drug packaging remains a priority for manufacturers and the FDA, as explained by John Shabushnig, PhD of Insight Pharma Consulting and Richard Watson of Merck at the 2019 Parenteral Drug…
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