News

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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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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