GMP News - Pharmaceutical Technology

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.

In June 2017, the FDA opened a docket intended for public comments on the topic of continuous manufacturing. The FDA seems mainly interested in receiving comments on the C-SOPS document which was already published in 2016. This document contains recommendations of a group of U.S. university and industrial representatives regarding continuous production.

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.

In the EU database for Non-Compliance Reports of European inspections, there is a new entry for the inspection of a pharmaceutical manufacturer in India from November 2017. Main focus of the findings: cross contamination.

The European Health Agency EMA publishes Non-Compliance Reports by GMP inspectors in their EudraGMDP database. A report of impressive deficiencies at a pharmaceutical manufacturer's site in Romania based on an inspection in summer 2017 is available there, as well.

Up-to-date monitoring systems produce vast amounts of data, e.g. pressure, humidity and temperature in clean rooms. In pharmaceutical production practice, there are different approaches to handle this electronic data - alarms especially. Not all of them are ideal from a GMP viewpoint.