GMP News - Validation


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.



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.



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. 



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.



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.



EMA Management Board adopts new Policies

The European Medicines Agency's (EMA) Management Board adopted a number of important policies at its 68th meeting. Read more.



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.



FDA Plans New Part 11 Inspections

The topic of electronic records / electronic signatures is again on the FDA's current agenda. On 8 July 2010, the Agency announced that it would increasingly focus on the implementation of the 21 CFR Part 11 requirements during upcoming inspections. Read more here.



FDA Publishes Draft Guidance on Third-Party Audits of Medical Device Manufacturers

The FDA announces the draft of a guidance for medical device manufacturers aiming at including audit results according to ISO 13485 into a risk-based working programme by the FDA. One of the objectives is a reduction in FDA inspections. Read more here.



Warning Letter Analysis for Process Validation

Because the US GMP Regulations do not address Process Validation in an own paragraph, it is not easy to immediately catch deficiencies in this area in Warning Letters issued by the FDA. For that reason you will find a detailed analysis for process validation deficiencies for the fiscal year 2009 here.



Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices

Webinars are an efficient method for imparting information. A recent webinar with John Murray, FDA, is now available. Here you can read more.



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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