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Analytical Services
Research Library
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Lancaster Laboratories
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Profiling of impurities in biopharmaceuticals and their associated intermediates and excipients is a regulatory expectation. Since residuals are typically present at low levels in difficult sample matrices, development and validation of assays can be quite challenging. Matrix types can vary greatly due to the fact that sampling at a variety of process steps is required to accurately monitor ...
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Lancaster Laboratories
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The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices and components utilized in the manufacturing of the product. Packaging includes components such as vials, caps and stoppers. Drug delivery devices include nebulizers, syringes, medical devices and various types of inhalers. ...
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Blue Grotto Technologies, Inc.
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“Which product in a class should be on formulary?” “What are the economic benefits and risks to adding a product to Tier 2?” Managed care organizations (MCOs) have numerous decisions to make each day. Many of these impact their bottom line. Therefore, it is necessary for the information being used to make the decisions be correct and presented in a fashion that is easy to understand. ...
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SafeBridge Consultants, Inc.
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In the manufacture of potent active pharmaceutical ingredients (APIs) and products, there is a need to conduct qualitative and/or quantitative healthbased risk assessments for both occupational and product (patient) safety purposes. When performed from an occupational standpoint, qualitative health-based risk assessments involve the categorization (“banding”) of the API based on toxicity and ...
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Lancaster Laboratories
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In August 2009 the Food and Drug Administration released a guidance for industry titled, Pharmaceutical Components at Risk for Melamine Contamination. The document, identifying various raw materials that are considered high risk for melamine contamination, recommends monitoring of these raw materials for the presence of melamine prior to release into production. The FDA also provided links to ...
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