GMP 3 and 5 chapters

Blog Miguel Ruiz Clean rooms, Pharmaceutical support 0 comentarios 8 - 04 - 15

PHARMACEUTICAL FACILITIES TO FACE THE NEW GMP CHAPTERS 3 AND 5

Last modifications on European GMP, which are taking effect on Mach 15th, (Chapter 3 and especially Chapter 5) are going to impact on existing facilities and equipment, and they are going to force a rethinking of all steps and measures to be taken in order to avoid cross contamination; not just for these products so-called “high potency” but in general for all pharmaceutical products. Every pharmaceutical product must have a risk analysis based on a toxicological assessment. Measures to be taken in order to avoid cross contamination will be determined in accordance with a risk analysis, based on the Quality Risk Management principles and they should be commensurate with the risks