Assessment of a pharmaceutical laboratory to meet the requirements of the new Annex 1

As a result of the changes introduced by EU GMP Annex 1 on the Manufacture of Sterile Medicines and despite the fact that it has not yet been finally approved as of today, some pharmaceutical laboratories with sterile production have decided to move towards its compliance beforehand.

Although it may seem premature, given that the regulations have not yet been definitively enacted, it is clear that moving towards their implementation is highly beneficial as they are an improvement on current practices which are already applied by large reference laboratories today. Taking into account that the drafts of the new regulations do not usually vary significantly from the later official versions, proceeding before the new requirements are adopted is a prudent measure, which allows sufficient time for planning the actions that must be carried out to update procedures and practices, and to organize the investments that must be undertaken to adapt to the latest technologies.

This article illustrates how the new requirements specified in the current draft of Annex 1 have been implemented in a pharmaceutical laboratory that wanted to anticipate its entry into force, by applying a methodology based on the in-depth assessment of its facilities and its quality management system with regards to the new requirements, and culminating in the elaboration of an action plan that allows for correcting and solving the deviations and deficiencies observed.

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