EU Makes Major Update to Drug Manufacturing Guidelines

Friday, April 3, 2015

Source: RAPS

For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation.

The update to EurdraLex Volume 4, Annex 15: Qualification and Validation goes into effect on 1 October 2015. The new version accounts for significant changes in the regulatory environment and will align with guidelines from the International Conference on Harmonisation (ICH).

Background
Annex 15 contains the requirements for qualification and validation of processes, equipment and locations used to manufacture pharmaceutical products. These requirements are part of the good manufacturing practice requirements established in EudraLex Volume 4 and require manufacturers to ensure that “critical aspects” of their operation are validated throughout the product lifecycle. This includes any changes that could impact a product’s quality.

Major Changes
The new version of Annex 15 places greater emphasis on risk management than the previous document, and adds new requirements to reflect changes in the manufacturing and regulatory environments.

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