Parenterals, Particulates, and Quality by Design

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 … Read more

Improving Visual Inspection Practices

Improving Visual Inspection Practices, written by Jennifer Markarian with Pharmaceutical Technology, she interviews John Shabushnig, PhD and talks about the need of improving the understanding and practice of visual inspection of parenteral drugs. Their interview gives guidance of where to search for help, as well as what is recommended. PDA and USP have been working together … Read more

Particulates in Parenteral Products and the Search for the Holy Grail

Particulates in parenteral products as well as other pharmaceuticals have gained increased attention from regulatory agencies and from pharmaceutical firms who desire to be in the forefront of patient safety and effectiveness in the products they supply for patients.  Foreign particulates in parenteral products come from multiple sources and can vary widely in type, size … Read more

Controlling for Particulate Matter in Injectable Drug Products

Ever since the development of the earliest intravenous therapies, the presence of particulate matter in injectable drug products has been a concern among clinicians. In recent years, there has been an increase in the number of drug product recalls due to the presence of particulate matter. These recalls are actions taken by a company to remove … Read more