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EMA publishes Draft on the Process Validation Guideline

On 15 March 2012, the EMA published the long-awaited revision of the Process Validation Guideline. The finalised document will replace the current valid guideline entitled "Note for Guidance on Process Validation". Comments to the draft can be sent until 31 October 2012. Click here to read more.

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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.

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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.

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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.

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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.

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FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices

In May, the FDA published a Draft Guidance for Industry and FDA Staff entitled "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".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

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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.

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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.

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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.

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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. 

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