European Commission Consults on Revised GMPs for Sterile Drugs

Regulatory NewsRegulatory News | 20 December 2017 |  By 

The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4.

The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times since its initial publication in 1971.

A 50-page consultation document was also released alongside the announcement, roughly triple the length of the current version that came into effect in March 2009.

The key changes being sought are: the addition of new guidance on utilities such as water, air and vacuum systems; environmental and process monitoring; the introduction of quality risk management (QRM) principles; and a glossary section.

According to the newly added scope section, the Annex "provides general guidance that should be used for all sterile medicinal products and sterile active substances, via adaption, using the principles of quality risk management, to ensure that microbial, particulate and pyrogen contamination associated with microbes is prevented." The consultation also notes that the recommendations can be applied to the manufacture of other non-sterile products, such as creams, ointments or low bioburden biological intermediates where controlling contamination is important.

While the previous version of Annex 1 contained a number of recommendations for utilities throughout the document, the revised version contains a section dedicated to utilities that describes a risk-based approach to utilities controls, with specific subsections for water systems, steam used for sterilization, compressed gases and vacuum systems and cooling systems.

The revised version also includes more detailed recommendations for environmental monitoring and process monitoring, including non-viable monitoring, viable monitoring and aseptic process simulation.



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