News

New Version of the ECA Visual Inspection Guidance

The ECA Visual Inspection Group has completed an updated version of the ECA Guide on Visual Inspection of Parenterals.

More
New Version of the ECA Container-/Closure-Integrity Position Paper

The ECA Visual Inspection Board Members worked on a new version of the Container-/Closure-Integrity Position Paper, which has now been published.

More
New USP Chapters regarding Testing for Subvisible Particles

The USP has published the revised chapter on testing for non-visible particles <1788> as well as new monographs on the individual test methods light obscuration, membrane microscopy and flow imaging as drafts.

More
Do liquid, sterile medicinal products have to be particle-free?

According to the pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection purposes, must be 100% visually inspected. In addition to damages to the primary container, the absence of particles has also to be checked. But do these medicinal products also have to be 100% free of particles? Read more here.

More
EMA: Work on Annex 1 and Annex 21 will continue

Because of Brexit, the European Medicines Agency (EMA) further needs to reduce activities. However some EMA acitivities will continue as planned.

More
European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles

The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.

More
Successful ECA, USP and EDQM Joint Conference on Glass packaging

The "Glass meets Pharma" conference on glass packaging was held in early June in Berlin. Read more about the presentations and discussions at the first USP, EDQM and ECA Joint conference.

More
FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

More
New Ph. Eur. Developments in the Visual Inspection of Injectables

Ph. Eur. chapter 2.9.20 on the visual control of parenterals is currently being revised. There are no major changes expected. What is much more interesting is the announcement of a new advising chapter. Read more about the new chapter 5.17.2 on visual inspection.

More
How a 483 turned into a Warning Letter for Celltrion in South Korea

The South Korean company Celltrion had received a so-called 483 FDA report as a result of inspections performed in May and June 2017. Deficiencies were mainly observed in the aseptic area. Due to the - in their opinion - insufficient answer to the 483 report, the FDA has now issued a Warning Letter.

More
x
Search