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this is voices invalidation brought to you by ivt network ivt network is your expert source for life science regulatory knowledge voices and validation brings you the best in validation and compliance topics we interview industry experts from pharma biotech med devices and laboratories here is the host of voices invalidation stacy thank you and welcome to another episode of voices and validation brought to you by the ivt network the much discussed revision to the eu gmp annex one is expected to be published early this year bringing some major changes to drug developers current process and manufacturing methods for sterile products although the draft revision has been widely shared and commented on it is still unclear of the total impact this document may have across regulated industries so here to share his perspective on the annex one revision document is patrick newenhausen from pharmalex welcome patrick great to have you with us today thank you stacy thank you absolutely absolutely so i really appreciate your insights uh into this as annex one although a uh european document you know definitely has impact globally um and the last revision to this document came in 2017 with a draft revision in the works for the past couple of years so people have had time to look at this and ask their questions and make their comments but my question to you is what is annex one and what's the importance in pharmaceutical manufacturing okay well uh annex one it's part of a of a bigger collection of documents of the usual x at the moment usually x volume four and it basically translates or interpret the basic principles of gmb from what is now the european directive what is it 2003 94 eec it's it's quite old document it was first published in 1971 and it was revised a few times on some point but never fully revised and as the title of the annex one implies it is the european guidance document for the manufacturing of stellar products and it provides guidance on the minimum controls that pharmaceutical companies are required uh to have implemented to produce medicinal products that are required to be sterile and so all these manufacturers they have to comply with these requirements to minimize basically the risk of microbial particulate and pyrogen contamination that comes from microbes in the final product so um it's a very important document as you as you can imagine as it as it outlines all these different requirements that ultimately uh gives a higher level of assurance that your final product is sterile excellent thank you just for the little bit of background on that and so patrick some of the greatest proposed changes to annex one are seen with clean rooms clean air systems and environmental monitoring um why is that so important now why are those items do you think so important now well as i said the the document itself it comes is originated from 1971...