GMP News - Validation


ISPE Guide assists modern Qualification

When the FDA Process Validation Guidance mentioned the ASTM Standard E2500-07 in connection with modern approaches to qualification, interest was raised in this document. But the Standard is relatively short and not very specific. Now, interpretation is offered by an ISPE-Guide.



European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation

To find out what the European pharma industry thinks about the announced revision of the Process Validation Note for Guidance by the European Medicines Agency, the European Compliance Academy (ECA) together with Concept Heidelberg conducted a survey in September 2011. Read more here.



Technical Report - Assistance for Biotechnology Cleaning Validation

Since the Nineties, cleaning validation has been a topic in the area of GMP. Most guidelines cover the topic of cleaning validation only in a general way. The PDA's Technical Report No. 49 focuses on biotechnologically-manufactured products. This document consists of 68 pages, divided into 16 chapters. Read more here.



FDA publishes Analysis of 2010 Warning Letter Statistics regarding Medical Devices

The FDA Center for Devices and Radiological Health (CDRH) has recently published the Warning Letter Statistics for Medical Devices. Read more here.



FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The document should … Read more here.



Why did FDA change their Guideline on Process Validation?

The 4th European GMP Conference took place in Heidelberg on 19/20 May 2011. During the Conference, Grace McNally, co-author of the new FDA Process Validation Guidance presented the reasons for the revision of this Guidance. Read more here.



New EMA Concept Paper on Process Validation of Biotechnology derived active Substances

On 19 May 2011, the EMA published a "Concept Paper on the need for a guideline on process validation of medicinal products containing biotechnology derived proteins of active substances". For the EMA, it was necessary to develop a Guideline, ... read on here.



EMA's answers to FAQ on Computerised Systems

The EMA (European Medicines Agency) has just published answers to questions on computerised systems under "Q&A: Good Manufacturing Practices (GMP)". Read more here.



FDA Warning Letter Statistics 2010 regarding Process Validation and Qualification

In Warning Letter evaluation, the topic of process validation/qualification is not frequently observed since it is not an independent item of the cGMP Guide (21 CFR 210/211). In the following, you will find an evaluation of the Warning Letters 2010 on GMP deviations in regard to process validation and qualification in the manufacturing environment. Read more here.



Requirements on Validation of Sterilisation Procedures according to ISO 17665-1

Qualification of a steriliser and validation of sterilisation procedures are essential GMP requirements for the manufacture of sterile medicinal products. Requirements on these topics can be found in the pharmacopoeia and in Annex 1 of the EU GMP Guide. However, there are no further executive regulations. In case of sterilisation procedure using moist heat, the EN ISO 17655-1 standard can be helpful. Read more here. 



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.


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