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European Journal of Parenteral & Pharmaceutical Sciences International Circulation over 25 years of advancing pharmaceutical and healthcare sciences the pharmaceutical & healthcare sciences society European Journal of Parenteral & Pharmaceutical Sciences 2016 Volume 21 Number 2 THE JOURNAL OF THE PHARMACEUTICAL AND HEALTHCARE SCIENCES SOCIETY (PHSS) CONTAMINATION CONTROL Safety in Numbers The Number 1 Choice for Transfer Disinfection Klercide Sporicidal Alcohol has all the right vital statistics when it comes to safe transfer of items into aseptic areas. ñ Sporicidal effi cacy in 2 minutes* ñ Flash-off in 2 minutes ñ Broad spectrum effi cacy against: ċviruses in 1 minute (EN 14476)** ċbacteria in 2 minutes (EN 1276)** ċfungi in 2 minutes (EN 1650)** Make the fi rst move to improve your transfer disinfection process by dialling our number below. FOR MORE INFORMATION ABOUT OUR SINGULAR SOLUTION, CONTACT YOUR ECOLAB CONTAMINATION CONTROL EXPERT, EMAIL US AT [email protected] OR CALL +44 (0)2920 854 390 CONTAMINATION CONTROL WITHOUT COMPROMISE ECOLAB CONTAMINATION CONTROL REFERENCES * modifi ed EN 13697 sporicidal surface test - log 2 reduction achieved Brunel Way, Baglan Energy Park ** clean conditions Neath SA11 2GA UK USE BIOCIDES SAFELY. ALWAYS READ THE LABEL www.ecolabcc.com AND PRODUCT INFORMATION BEFORE USE. © 2016 Ecolab All rights reserved 8235/04.16 EDITORIAL BOARD CHAIRMAN OF THE PHSS European Journal James Drinkwater F Ziel GmbH, UK EDITOR-IN-CHIEF of Parenteral Kay O’Hagan Tecmac UK Ltd, UK Bengt Ljungqvist & Pharmaceutical Chalmers University of Technology, Gothenburg, Sweden Tim Sizer Sciences Southmead Hospital, Westbury-on-Trym, Bristol, UK 2016 Volume 21 Number 2 MANAGING EDITOR Sue Briggs T: +44 (0)1295 688028 E: [email protected] Contents PUBLISHER Euromed Communications Editorial: EU and the US – vive la différence? 35 Passfield Business Centre Liphook, Hampshire GU30 7SB Peer-reviewed Papers T: +44 (0)1428 752222 Equations for predicting airborne cleanliness in non-unidirectional F: +44 (0)1428 752223 airflow cleanrooms 38 E: [email protected] W Whyte, N Lenegan and T Eaton www.euromedcommunications.com INTERNATIONAL REVIEW BOARD Deposition velocities of airborne microbe-carrying particles 45 Rosamund Baird W Whyte and T Eaton University of Bath, UK The use of a single growth medium for environmental monitoring Stephen Denyer University of Brighton, UK of pharmacy aseptic units using tryptone soya agar with 1% glucose 50 Gordon Farquharson John Rhodes, Jennifer Feasby, Wayne Goddard, Alison Beaney and Mike Baker Critical Systems Ltd, UK Regulatory review 56 Michael Jahnke Haupt Pharma Wulfing GmbH, Malcolm Holmes Gronau/Leine, Germany PHSS activity and initiatives report 64 David Jones Rapid Micro Biosystems, USA Brian Matthews Instructions for authors in this issue or from our website: www.euromedcommunications.com South Croydon, Surrey, UK Simon McEwen Consultant, UK Didier Meyer DMCompliance, France The European Journal of Parenteral & Pharmaceutical Sciences is the quarterly journal of the Pharmaceutical and Stephen Moss Healthcare Sciences Society (PHSS). The journal provides a forum for publishing original peer reviewed papers, University of Bath, UK editorials, reviews and science & technology articles on all aspects of pharmaceutical and healthcare sciences. Papers Gerry Prout will normally be published within six to nine months of acceptance. Kennet Bioservices Ltd, Swindon, UK The European Journal of Parenteral & Pharmaceutical Sciences will also contain articles based on the proceedings of the Confederation’s scientific meetings, symposia and workshops. All submissions are subject to Berit Reinmuller peer review by members of the editorial board and external referees. Advice to contributors is available from the Chalmers University of Technology, managing editor. The journal is published quarterly and is indexed in Scopus (http://info.scopus.com) and Embase Gothenburg, Sweden (http://www.embase.com). It is provided free of charge to full and associate members of the PHSS. For non- Kirit Sanghani members the annual subscription is £90 (personal rate) or £180 (institutional rate), plus annual postage costs of Siemens Healthcare, UK £12. Back issues are available at £25 each (abstracts of back issues can be viewed on our website at Khalid Sheikh www.euromedcommunications.com). Cheques (drawn on a UK bank) should be made payable to Euromed University College London, UK Communications. Subscription orders should be sent to the publishers’ office. Reproduction of articles published in the journal, in whole or in part, is not permitted without the previous written ADVERTISEMENTS consent of the author and editor, and the usual acknowl edge ments must be made. Authorisation to photocopy items for Allan Andrews internal or personal use is granted by the PHSS. Requests for reprints should be made to the publishers, Euromed Tel +44(0)1428 752222 Communications. Fax: +44(0)1428 752223 While all reasonable care has been taken in preparing this journal, neither the publishers nor the PHSS can accept E: [email protected] any responsibility for the accuracy of the advice or information contained in the journal. PHARMACEUTICAL AND HEALTHCARE Statements and opinions expressed in the articles and communications herein are those of the author(s) SCIENCES SOCIETY and not necessarily those of the PHSS, the editor or the publishers. Tamsin Marshall The PHSS, the editor and the publishers disclaim any responsibility or liability for such material and do not 6A Kingsdown Orchard, Hyde Road, guarantee, warrant or endorse any product or service advertised or mentioned in the publication nor do they guarantee Swindon SN2 7RR any claim made by the manufacturer of such product or service. Tel: +44 (0) 1793 824254 © 2016 Pharmaceutical and Healthcare Sciences Society Fax: +44 (0) 1793 832551 A publication of the Pharmaceutical and Healthcare Sciences Society E: [email protected]; W: www.phss.co.uk The journal is published quarterly and indexed in Embase and Scopus ISSN: 0964-4679 OUR TEST, YOUR CURE... ENSURING A HEALTHY WORLD YOUR Endotoxin Experts! Associates of Cape Cod Int’l., Inc. Deacon Park, Moorgate Road Knowsley, Liverpool L33 7RX, United Kingdom Tel: (44) 151–547–7444 * [email protected] * www.acciuk.co.uk European Journal of Parenteral & Pharmaceutical Sciences 2016; 21(2): 35-36 © 2016 Pharmaceutical and Healthcare Sciences Society Editorial: EU and the US – vive la différence? Will the differences in legislation and culture Regulatory Agency (MHRA) inspector for advice between the US and Europe mean that mutual or clarification is common. I have never heard of recognition agreement (MRA) will never happen? this sort of informal discussion with FP batch Mutual recognition is about accepting that the approval within the US industry and the US Food competent authority good manufacturing practice and Drug Administration (FDA) but it is becoming (GMP) standards and expectations leading to batch more common place to approach the FDA for manufacture, testing and approval are equivalent. informal guidance. The difference in approach of If the UK leaves the EU, a UK/US and UK/EU the agencies is often generally described as: the MRA are possible. But what is the value of the FDA are investigators – the MHRA (as an EU MRA? For the company, there are huge financial example) assist towards compliance. benefits. This cost saving is mainly in the With site approval in the US, there is annual laboratory retest requirements. For the competent company registration (once the company has been authorities, there are huge benefits as the global inspected and approved) which is independent of an audit workload is greatly reduced. For the qualified inspection program. FDA inspections are scheduled person (QP), there is not so much benefit. There and based on risk (as with Europe), but typically will always be a spectrum of GMP compliance in short notice or no notice inspections are held. There any country and the existence of an MRA means are differences in approach between the EU and the that each party to the agreement has equivalent US to FP batch release, MA and MIA and GMP standards. It does not mean that each approachability of investigators/inspectors. company invariably meets the standards. However, my understanding of the lack of an The EU situation with batch approval of a MRA between the EU and the US is the US finished product (FP) for market release is about a perception of EU diversity in EU member state personal responsibility. A release site is named on a GMP standards and the enforcement of these marketing authorisation (MA), certifying QPs are standards within the 28 EU member states. While named on the site manufacturing and importation the US would be comfortable with a number of the licence (MIA). The named QP must be approved by member states, they are not happy with the GMP the EU competent authority before being approved standards of all 28. This unhappiness is not only to certify FP batches for release. with some of the new member states, but with some In the US, a person is deemed to be suitably of the founder members of the EU. qualified to approve FP batches by company The same pharmaceutical directives apply to all appointment. However, the 21CFR211 requires the 28 EU member states and although they are locally person to have appropriate training, education and interpreted into law, the same GMP guidelines are experience and this would be verified on audit. In applicable. The European Medicines Agency has the EU, it is both by the company who submit the made it clear that any MRA must be applicable to variation and by the relevant competent authority all countries or not at all. who approve the MIA. In my experience of auditing in the EU member In the EU, QP certification is about personal states, there is a spectrum of site GMP compliance. responsibility and the QP essentially performs the This compliance spectrum is more a function of the task independently of the company. The site ownership and management than the country in certification of batch compliance by a QP is as which it is situated.
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