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The Proposed Changes to Annex 1 draft February 2020: Review of impacts on the requirements for Cleaning and Disinfection

April 21, 2020

It is worth taking a moment to review the road that led to the long‐awaited update of Annex 1 of EudraLex Volume 4 ‐ Good Manufacturing Practice (GMP) guidelines.

In 1989 the first edition of the guide ‘EudraLex The Rules Governing Medicinal Products in the European Union’ which amongst its volumes included Volume 4 ‘EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use’ was published, and included an annex on the manufacture of sterile medicinal products.

A second edition was published in 1992, and further updating and re‐structuring of the guide followed.

Annex 1 was also revised during the 2000s, but no complete review of the annex has been carried out since the last revision issue in 2008 – over 10 years ago. A complete rewrite has therefore been long overdue.

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