GMP News - Validation


EMA revises its Process Validation Guidelines

In a draft paper, the European Medicines Agency (EMA) announced the reworking of their guidelines on process validation. Is this an attempt at European convergence with the FDA life cycle model? Read more here.



New EU Requirements in the Validation Process in the Form of a Revision of Section 1 of the EC GMP Guidelines?

In the draft revision of Section 1 (Quality Management System) of the EC GMP Guidelines, the topics of "process performance" and "state of control" also play a major role. These topics are also referred to in Step 3 of the process validation life cycle in the new FDA Guidance on Process Validation draft. Are the Europeans beginning to come into line with the FDA? Read more here.



Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?

In a recent questions-and-answers paper, the question if, according to cGMP, the manufacture of 3 validation batches is required before a new active pharmaceutical ingredient or medicinal product can be marketed is answered by the FDA in the negative. The reasons for the no can be found here.



Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA

An information sheet by the VDMA (German Process Plant and Equipment Association) gives recommendations on the standardisation of the riboflavin test (test of cleanability). Read more here.


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