GMP News - Validation

02.02.11

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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27.01.11

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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19.01.11

New EU GMP Guide Annex 11 "Computerised Systems"

In Europe the EU GMP Guide Annex 11 "Computerised Systems" is the regulatory basis for GMP regarding IT systems in the pharmaceutical industry. The new version was issued on 3 January 2011 together with the EU GMP Guide Chapter 4 "Documentation". It will become effective on 30 June 2011. Read more.

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15.09.10

The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way

Alongside validation, the (GMP-compliant) operation of computerised systems is also becoming an increasingly higher priority. A new GAMP Good Practice Guide gives comprehensive support on this matter. Read more here.

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08.03.10

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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13.01.10

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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