IPEC e-newsletter - Excipients Insight January 2018 - 20-01-18


Inside this issue


EC unveils draft revisions to sterile drug GMP guidelines

Towards the end of 2017, the European Commission published a draft revision to its Good Manufacturing Practice (GMP) guidelines on the production of sterile drugs.

The EC has drawn up a new draft of Annex 1 ‘Manufacture of Sterile Medicinal Products’ - the first revision to the document since 2008 – and has published a consultation document that is open for comments until 20 March 2018.

The purpose of the revision is to add clarity to the Annex, introduce the principles of quality risk management (QRM), cover new technologies and processes, and change the document structure to a more logical flow.

Some of the changes include changes to the recommendations on clean rooms - taking revisions to ISO 14644 standards into account – as well as single-use systems. It also includes dedicated sections on utilities (water, sterilization, filtration and cooling systems used in the production of sterile drugs) as well as environmental and process monitoring.

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 EC also notes that the recommendations can be applied to the manufacture of some non-sterile products, such as creams, ointments or low bioburden biological intermediates where controlling contamination is important.

The new revision has been prepared in collaboration with the World Health Organization and PIC/S, who will have a say in the finalised version.




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