News

EMA revises Process Validation Guideline

A News from March 2014 reported about EMA's revised process validation guideline entitled "Guideline on process validation for finished products - information and data to be provided in regulatory submissions". Now, the EMA has surprinsingly published a new revision of its Process Validation Guideline.

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ECA Validation Group: Survey Results

The ECA Validation Group which currently counts 193 members is one of ECA's seven Working/ Interest Groups. We've asked the members of the Validation Group about their topics of interest and in which direction the group should evolve. Find out more about the survey results.

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APIC updates its Guidance on Cleaning Validation with regard to the PDE Concept

A news in June 2014 already reported about the APIC "Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Now, a revision has brought the APIC guidance in line with EMA's guideline on "Shared Facilities".

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WHO publishes Qualification Guideline for Comment

The WHO is currently revising its validation guidelines and has recently published a superordinate umbrella guideline. Now, an independent chapter on qualification was published for comment.

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WHO publishes Draft of an Umbrella Guideline on Process Validation

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Please find here an analysis of this draft.

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EMA publishes finalised Process Validation Guideline for Biotech Products

Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission". 

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Medical Devices Warning Letter Statistics 2015 - Process Validation again in the Top 5

In a recent news we reported about statistics of the FDA from the first half year 2015 with regard to Warning Letters addressed to medical devices manufacturers. Please read more about the current evolution of the top 5 list regarding medical devices for the complete fiscal year 2015 (1 October 2014 to 30 September 2015, as of 10 October 2015).

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ECA publishes revised version of Good Practice Guide on Process Validation

After the FDA moved towards a life cycle approach with its Process Validation Guidance in 2011, the EU GMP Guide now followed with the revision of Annex 15, also moving to modern process aspects (e.g. life cycle approach). But how can the industry implement the new process validation requirements? The ECA's Good Practice Guide on Validation does provide answers.

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Annex 15 and FDA Process Validation Guideline: Similarities/differences from the FDA perspective

The "new" FDA Process Validation Guideline has been in force since January 2011. The revised Annex 15 has been valid since 1 October 2015. At a Conference in September 2015, which was co-sponsored by the FDA, Grace McNally, Senior FDA Official, reported about similarities and differences between the two documents from the perspective of the FDA.

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Validation - Revision of Annex 15: How does the Industry see the Changes? - Results of an ECA Survey

With the publication of a draft on the revision of Annex 15 at the beginning of February 2014, changes in the area of validation/qualification were to be expected. Even then, the European Compliance Academy (ECA) started an industry survey. Now the final document is ready and the changes will become valid on 1 October 2015. How does the industry see the new requirements in Annex 15?

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