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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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New EU GMP Annex 15 Revision published - Valid as of 1 October 2015

In February 2014 the draft for the revision of Annex 15 was published. Compared with the currently valid version the changes were partly significant. Now the draft was published as final document and will be valid as of 1 October 2015. Read more about the Changes in Annex 15.

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Detailed Requirements concerning the DOE in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

The EMA has published together with the FDA a new question & answer (Q&A) paper at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Among others it contains the answer to the question "What level of detail should be considered for design of experiments (DOEs) in a regulatory submission?"

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Requirements for Risk Analyses in the Regulatory Submission Dossier: EMA's and FDA's Recommendations

The EMA has published a new question & answer-(Q&A) paper together with the FDA at the end of 2014. This document answers questions on detailed requirements in connection with the documents concerning regulatory submissions. Read the answers to the topic risk analysis here.

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