News

FDA Warning Letter Statistics 2011 with regard to Process Validation / Qualification and Calibration

In the Warning Letter Report 2011, statistics have been published about FDA’s Warning Letters (issued to drugs and API manufacturers) during the fiscal year 2011 (from October 2010 to September 2011). The topics Process Validation / Qualification haven’t been considered separately. In the following, you will find a summary from the 39 Warning Letters 2011 on GMP deviations regarding Process Validation, Qualification and Calibration in the manufacturing environment.

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ISPE Guide bridges traditional Qualification and risk- and science-based Qualification

In last week's news we talked about an ISPE Mapping Document that illustrates relationships to other ISPE Guides on qualification. One of these ISPE Guides, the ISPE Good Practice Guide "Applied Risk Management for Commissioning and Qualification" is used as bridge in order to connect traditional qualification approaches according to ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&Q) to a modern risk- and science-based qualification approach. Read more.

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ISPE Mapping Document explains Relationship between different Qualification Guides

The ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&G) has been available since 2001. Now, an ISPE mapping document explains the relationship between the ISPE Baseline Guide Volume 5 and the new ISPE Guide "Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment" (FSE Guide). The mapping document also presents an ISPE Guide (Applied Risk Management Guide) which has the function of a "bridge" between these two documents. Read this news to get an overview of this "Mapping-Document for ISPE Specification and Verification Guides" that explains the relationship of different ISPE Guides with regard to qualification.

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Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA

In our news from 4 July 2012 we reported on a publication on the results of inspections carried out by the MHRA (Medicines and Healthcare Products Regulatory Agency, MHRA). It is worthwhile to take a look at this publication also beyond the actual top ten list of deficiencies, since there are relatively few publications on GMP deficiencies by European authorities. The following observations focus on the topics process validation/equipment qualification/calibration.

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New EMA Guideline on Real Time Release Testing

The concept of parametric release has been primarily used for the sterility testing of products terminally sterilised. Now, the new EMA Guideline will extend this alternative release strategy - Real Time Release Testing - to all types of APIs and finished products testing. Read more here in the News.

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New ECA Working Group on Process Validation starts first Project

Many members of the European Compliance Academy (ECA) have recognised that there is a paradigm shift in Process Validation. Therefore, the new ECA Process Validation Working Group has defined its first project: A Good Practice Guide with the goal to provide assistance relative to the new Process Validation requirements and specifically to "what to do" and "how to do it". Read more.

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Detailed Analysis of EMA's new Draft on Process Validation

We already informed about the availability of the new EMA Draft Guideline on Process Validation in one of our previous newsletters. Today we publish a detailed and comprehensive analysis of the document's content, the new requirements and the differences to the FDA Guide on Process Validation. Read more here.

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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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