Shifting the Focus from Testing to Manufacturing

July 7, 2015
BioPharm International Editors

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

The European Pharmacopoeia has incorporated new provisions that would encourage pharmaceutical manufacturers to shift focus from post-production testing, including animal testing, to the use of in-process and modern quality control methods. The goal would be to monitor consistency and variability during production.

The approach is already being used for the latest generation of vaccines, and is being studied in vaccine manufacturing, in the Vaccines Consistency Approach project, which was started by the European Partnership for Alternatives to Animal Testing (EPAA), with partners from industry, academia and government agencies. A May paper discussed the methods and approach being used in this project, and some issues involved in using this approach, especially for older vaccines whose manufacturing processes may not be that well characterized. In the end, the researchers conclude, the effort must be industry-led if it is to succeed. In the U.S., the move was originally pushed by regulators, specifically FDA, in efforts such as 21st century cGMPs and the Process Analytical Technologies (PAT) initiative. Click here to read the report.