News

USP expert answers questions regarding particulate matter testing

Scott Aldrich, member of the USP Dosage Forms Expert Committee, answered several very interesting questions regarding the USP chapters for testing of particulate matter during the ECA conference "Particles in Parenterals", 7-8 May 2013, Vienna. Please find the questions and answers here.

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Particles in Parenteralia - FDA’s perspective

An FDA representative talked about the US-American authority’s perspective as concerns particulate matter in sterile drug products at the ECA conference "Particles in Parenterals" in May this year. Read more here.

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AQL testing in the visual inspection of parenterals (FAQs)

An increasingly asked question is whether an AQL inspection is required as part of the visual inspection of parenterals. Get more details here.

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FAQs concerning the visual inspection of Parenterals

The issue manual versus fully automatic inspection with regard to a 100% visual inspection of parenterals is a frequently discussed GMP issue. Please find a list of Q&As on this subject in our GMP News Read more.

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USP's Position to the Glass Particles Issue

In response to growing product recalls due to glass particles found in injectable medications, the USP will present the new Chapter <1660> in the July-August edition of the Pharmacopeial Forum (PF). This new chapter describes methods to test the inner surface of glass containers. Read more here.

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