News

Indian Sterile Manufacturer receives a second Warning Letter

In March 2017, the FDA published another Warning Letter to an Indian pharmaceutical manufacturer due to GMP violations. The letter describes findings with regard to complaint handling, leaking of sterile products and the corresponding CAPA processing as well as on the non-compliance with quality agreements.

More
Visual Control by Doctor and Patient?

To avoid a supply shortage, batches of a lyophilisate manufactured by the company Jazz Pharmaceuticals which possibly contain visible particules are to be visually checked before administration and additionally filtered through a 5 µm strainer.

More
Warning Letter to Pharmaceutical Manufacturer in Singapore due to Leaking Sterile Containers

A manufacturer of sterile ophthalmics in Singapore has recently received a Warning Letter of the US FDA. Container leaks and the associated risk of microbial contamination were the main points of criticism.

More
FDA Warning Letter: Visible Particles and Visual Inspection

During an FDA inspection at the Kansas-based company Hospira in mid 2016, the FDA encountered several GMP violations which resulted in a Warning Letter. The GMP deficiencies concerning visual inspection as well as the handling of distributed batches which were contaminated with particles even lead to the assertion that the company's process of manufacturing injectable products was out of control.

More
FDA presentation at the ECA Conference Particles in Parenterals

At the Particles in Parenterals Conference Dr Stephen Langille from the US FDA gave a talk on the FDA's current thinking with regard to the visual inspection of medicinal products for parenteral use.

More
New Q&A Document on the Visual Inspection of Parenterals available

The ECA's Visual Inspection Group has developed a new document with answers to frequently asked questions. This new Q&A document is now available for download on the Group's website. Read more about frequently asked questions in the visual inspection.

More
Is AQL Testing required within the 100% Visual Inspection?

One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspection of parenterals. The answer is: basically, "yes".

More
ECA Visual Inspection Groups works on new FAQ Document

The advisory board of ECA's Interest Group for Visual Inspection is working on a revision of a document with frequently asked questions with regard to visual inspection of parenterals.

More
EU GMP Annex 1 Revision 2016 - what does the pharmaceutical industry expect?

Dr Friedrich Haefele, Vice President Fill & Finish Biopharma at Boehringer Ingelheim talked in his keynote speech at the Pharma Congress 2016 about the revision of Annex 1 of the EU GMP Guide. Read here what the pharmaceutical industry expects form the new Annex 1.

More
Revised USP Chapter <1790> on Visual Inspection published

After the long-awaited Chapter <1790> on visual inspection of injections was first published in the PF 41(1) as a draft the USP has now submitted a revised draft in the PF41 (6). Read more about the revised draft of the USP Chapter <1790>.

More
x
Search