With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
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 revised versions of two Ph. Eur. general packaging chapters have been published for comment in Pharmeuropa. Read more about 3.2.8. Sterile single-use plastic syringes and 3.2.6. Sets for the transfusion of blood and blood components.