News

Particles Filtration Not Acceptable

The EMA has recently added an interesting question to its Questions & Answers section. How acceptable is filtration of particles prior to the administration of a medicinal product for parenteral use? Read more.

More
ECA Working Group on Visual Inspection Founded

The European Compliance Academy now counts a new working group. In addition to the already existing working groups on validation, GDP, QC, rapid microbiology methods and the QP Association, a new group was created at the beginning of the year to address GMP Compliance in the visual inspection of parenterals. Read more here.

More
News from the US on particles in injectables

Particles in medicinal products for parenteral use as well as the 100% inspection on particles stay in the focus of the US American authorities. There are some upcoming changes in the USP with respect to particle inspection, which you can find here.

More
USP visual inspection expert answers question regarding AQL testing

Questions about the implementation or the need for AQL testing in the visual inspection of parenteral drugs are becoming more frequent. To get concrete answers to a specific question read on.

More
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.

More
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.

More
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.

More
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.

More
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.

More
x