Posted by Michael Wonder on 11 Aug 2016
Data integrity: key to public health protection
11 August 2016 - New guidance is now available on the EMA website.
The EMA has released new good manufacturing practice guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benefit-risk profile throughout their life span.
Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities.
