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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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Frequent GMP Question: How many Signatures are required for Validation Protocols/ Reports?

As part of the validation and qualification activities for the production of medicinal products, the following question often arises: how many signatures have to be put under the respective protocols and reports? Which part do the Heads of Production and QA play for the signatures? Read more about the answers provided by the EU GMP Guide.

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WHO publishes second Draft on the Revision of its Process Validation Guideline

Comments to the first draft on the revision of the current process validation guideline (for non-sterile processes) from April 2014 have now flowed into the second one. This is obvious at one point or another. Read more.

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Austrian QP Association (aqpa) publishes Comments on the Annex 15 Draft

The publication of the revised draft of the EU GMP Guide's Annex 15 is the opportunity for the EMA to get comments on it. The opportunity has been used by the Austrian QP Associaton (aqpa). Read more about the comments.

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APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants

An APIC multinational working group has compiled a new guidance on cleaning validation with the title "APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Publication date is May 2014 and the document can be downloaded from the APIC website. Here you will find a summary description of the document.

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