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Aide memoire of German Inspectors now also available in English

All the participants of the 4th European GMP Conference scheduled in Heidelberg on 19/20 May 2011 will receive the English version of the inspectors' guide (Aide memoire) on Qualification/Validation. Read more here.

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Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices

Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. In the following, you will find a ranking based on the evolution of the Top 5 deviations in the FDA Warning Letters (regarding Medica Devices) issued between the years 2002 and 2010. On place 1 is … Read more here.

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Detailed Analysis of FDA´s New Process Validation Guidance

Since November 2008 there is a draft for the revision of the old FDA Process Validation Guideline. On 25 January 2011 the FDA has published the final version of this new Process Validation Guidance. Read a detailed analysis here. 

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FDA publishes Final of new Process Validation Guidance

Since November 2008 there has been a draft for the revision of the old FDA Process Validation Guideline. On 25 January 2011 the FDA published the final version of this new Process Validation Guidance. Read more here.

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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.

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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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