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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).
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.
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.
One of the significant changes to Annex 15 is the addition of principles developed in ICH guidelines Q8, Q9, Q10 and Q11:
In the past, companies were able to validate their cleaning methods by conducting three consecutive successful cleaning procedures. The updated guidelines now require companies to conduct a risk assessment to determine the appropriate number of times a cleaning procedure must be performed.
The section on “Process Validation” is updated to include provisions for ongoing process verification during a product’s lifecycle. Companies should demonstrate that “a state of control is maintained throughout the product lifecycle,” and periodically assess the “extent and frequency of ongoing process validation.”
The new versi
EudraLex, Volume 4, Annex 15 (New Version), (Current Version)
Tags: Qualification and Validation, Good manufacturing practice, GMP