New ema guide - Ingelyt Clean Room Engineering - GMP Consulting

Blog Sin categoría 0 comentarios 13 - 01 - 15

New EMA Guide: Definition of the limits of exposition for the risk analysis in multiproduct installations

1.Introduction   The EMA has approved on the 20th of November 2014, the new guide “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. Once approved, this guide will have to […]

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Dedicated facilities versus multiproduct - Ingelyt Clean Room Engineering - GMP Consulting

Blog Pharmaceutical support 0 comentarios 23 - 10 - 14

Dedicated facilities versus multiproduct facilities

In pharmaceutical manufacturing plants there is always the doubt related to when it is necessary to have a dedicated facility or when it is possible to manufacture in a same area different products specially when some of them are steroids, sexual hormones, corticoids, cytostatics, high potency, prostaglandins, …
FDA and EU required dedicated facilities for betalactamics antibiotics and when manipulating pathogenic alive organisms. For the rest of products the segregation and dedicated facilities should be required when the physical and procedural controls cannot demonstrate the capacity to keep under acceptable control limits the risk of cross contamination

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