International Congress 1263

A3P Services22, Rue Aristide Briand

45220 Château-Renard - FranceTél. +33 2 38 071 071Fax +33 2 38 071 072

E-mail : [email protected]

Biarritz - France - October 15th, 16th & 17th, 2013SIMULTANEOUS TRANSLATION FRENCH/ENGLISH

Sterility assurance

Combination productsSingle use

➜ 16 Lectures ➜ 11 Workshops

➜ Exhibition ➜ Round table

2

Editorial

Sterility Assurance, a permanent concern!Endless topic is the STERILITY ASSURANCE, subject that will gather the 2013participants to the A3P 26th congress in Biarritz, along with the SINGLE USESYSTEMS and COMBINATION PRODUCTS, the whole being today more and morefrequently associated for the administration of treatments sometime complex. Thepresentations will put these topics into perspective, with their practical aspectswhich are daily questioning all contributors of the production chain. They are alwayslooking for improvements and innovations made possible by the evolution anddevelopment of new technologies; they force us to reopen the basics of currentpractices, what is really understood, but most and foremost what remains essential, in order to envisagethe evolutions around these practices, all to the service to the patient. Experts will share their experienceand potential perspectives.

The round table will discuss these questions in a structured manner, to review current thinking andevaluate the conditions to fulfill for the promotion of these evolutions, never forgetting that Sterility hasonly for good Company the Assurance that supports it!

Patrick TURLIER - GSK

Illustration François MOREL

Entire plant is for single use!...except the staff.

Who knows...

All the lectures are located in the Bellevue Congress Hall.

8h00 Welcome to the participants at the Bellevue Space

8h45 Introduction by the President of A3P AssociationGérard Ecotière

8h50 Opening lecturePatrick Turlier - GSK

9h00 When sterility assurance failsJean-Denis Mallet - NNE Pharmaplan

9h30 Environmental Monitoring & Process UnderstandingIan Symonds - GSK

10h00 From ionizing radiation of a MD to the sterility assurance of a combination productBruno Tissier - IPSEN

10h30 Break - Visit of the Exhibition

11h30 Rapid Microbial Methods (RMM) – The Microbiology of the 21st century?Benoit Ramond - Sanofi

12h00 VHP decontamination without Rogue BisSéverine Itier - Icare

12h30 The simulation of the aseptic process as a tool to improve the manufacturing process of the yellowfever vaccine bulkAntoine Diatta - Institut Pasteur de Dakar

13h00 Lunch

15h00 Risk analysis in aseptic process: how to quantify the aseptic risk on a conventional filling line or anisolator ?Emmanuelle Bracq - Lilly

15h30 Sterile single dose leak test by vacuum vaporisationJean Jaillot - Excelvision

16h00 Introduction of Technological Innovations for Improvement of Sterility Assurance Level of VaccineManufacturing ProcessesAntoine Akar - GSK Vaccine


17h30 cGMP requirements for Combination products: an overview of 21 CFR 4Philippe Joly - Easy Gmp

18h00 Combination Products: Trends and Emerging TechnologiesAndrew Koubatis - Altran

18h30 Exhibitors cocktail

3More informations and current events

about the Congress on www.a3p.org

Biarritz 2013LecturesTuesday October 15th

All the workshops are located in the Bellevue Hall.

8h30 Welcome to the particpants at the Bellevue Hall - Biarritz (France)

9h00 1st part of workshops (Choose your workshop from the following list and report your choice on the registration from page 11)

10h30 Break - Visit of the exhibition

12h30 Lunch

14h00 2nd part of workshops

16h00 Break - Visit of the exhibition

17h30 End of the workshops

20h00 Exclusive and unique Gala Dinner

List of workshops to choose from: The workshops are provided without simultaneous translation.

WORKSHOP N°1 (in french)

Implementation of a system of disinfection on injectable factory in biotechnologyA3P Representative: Isabelle Pautrel

Moderators: Ludovic Dreux - Genethon et Fabien Guerrin - Areco

The purpose of the workshop will be to conduct a project to install a system for decontaminating surfaces by air on a unit of production GMP on injectable productin biotech.

The implementation of this project will be to confront with the different problems of each phase, necessary for a successful installation

- From implementations plans of a production unit, define the specifications of air handling unit with its associated bio-decontamination device

- Define the monitoring needs of the system

- Define checkpoints and acceptance tests associated with setting up the system

- Define the qualification tests to establish : FAT, SAT, IQ, OQ

- Define preventive maintenance associated to be provided on the unit of injectable production, such as premises and equipment involved

At the end of the workshop, it will be presented feedback on one installation of a disinfecting system in a production of injectable in biotech.


Aseptic process – How to answer to remarks following inspections(e.g. FDA, ANSM, ANSES)A3P Representative: Jacques Navellou

Moderators: Olivier Chancel - Merial et Benoit Ramond -Sanofi

This workshop is intended for everyone, novices or experimented, and is considered as a training, a way to discover, to enhance its « aseptic » culture or simply totest its own arguments… It will let participants design a methodology on how to answer to remarks whatever they are and then answer altogether remarks followingan inspection on the aseptic field.

The workshop begins with a short presentation of the recent trends in terms of remarks issued by FDA/ANSM/ANSES inspections.

The workshop alternates sessions in subgroups as well as common sessions in a rather fast way so as to favor the diversity:

• 10 minutes of reflection in subgroups: “ Sterile Quality control” subgroup by Benoit Ramond and “ aseptic Proceeded” subgroup by Olivier Chancel

• 2x5 minutes of collective feedback to all the participants. Remarks studied during the workshop are 3 orders: - Usual remarks: "It is a school case and my siteshould be ready to face it", - Current remarks: "My site might get this remark the next time …", - Badly formulated remark: "Great, I am going to be able to developmy critical faculty".

The workshop ends by a short presentation on a possible way to answer to FDA/ANSM/ANSES.

Workshops

4

Wednesday October 16th

COMPLETE WORKSHOP


Workshops Biarritz 2013



WORKSHOP N°3

Trending data of environmental monitoring in a bio-decontaminated cleanroomA3P Representative: Didier Meyer

Moderators: James Drinkwater - PHSS et Jules Boulicot- Bioquell

Theory talks will be provided on cleanroom environmental monitoring, including the new ISO 14644 for Cleanroom Classification, and cleanroom biocontaminationrisk management and guidance, including the new PHSS Monograph titled “Controlled Environment Biocontamination Control”. Workshops will include generalcleanroom classification and environmental monitoring programs and root cause analysis and CAPA on bio-contamination events.


From aseptic manufacturing to gamma sterilisation of a combination productA3P Representative: Vincent Griffoul

Moderators: Bruno Tissier - Ipsen et Gilles Daneyrolle - Ionisos

This case study workshop will work on the example of the re-ingeneering of an existing aseptic processed drug product, to a new combo presentation sterilized bygamma irradiation. In a second time, the option of parametric release advantages and practicability would be discussed.

Taken into account the current EU applicable reference standards, each of the three sub group will work respectively on: 1) the medical device 2) the drug Productand 3) design of the specific validation plan.

Pragmatical methodology, main critical parameters of device and process, and finally parametric release will be considered and evaluated.


Analysis of criticality function/constituent of a system of cleaning in place (CIP)A3P Representative: Sophie Amadio

Moderators: Robin Bigot - Cophaclean et Sandrine Duclos - Novartis Santé Animale

Presentation of a method of criticality analysis function/component adapted to a system of cleaning in place (CIP) in pharmaceutical industry, allowing: to define thetests of qualification to be made, to maintain the conditions of this qualified state, to simplify the process of change control.

Trough this methodology, this worshop will allow the participants to improve their knowledge on the functioning of a system of cleaning in place.

The progress of the day: presentation of the methodology, overview on a real case scenario: definition of the functions, the components and tests of associatesqualification.


Bacterial and viral biofilms prevent from production and preservation of germ freewater. These bacterial and viral communities are genuine biological fortress,bactericidal and virucidalproof. In order to obtain pharmaceutical pure waters,protected against exogenous contaminations, specific water treatment productionsystems and devices are introduced with additional instructions.A3P Representative: Arnaud Carlotti

Moderators: Henry Lerat - Burkhalter AG et Frédérique Le Bouquin - Veolia Water France

Biofilms

1-a) we’ll study their development (from birth to lysis). First particles adhesion – growth – glycocalyx forming – ripeness – and lysis. We’ll study also bacterial ADNas glycocalyx reinforcement agent.

1-b) Viral biofilm: specific analysis

2) Work shop. The participants in work shop conceive a biofilm free plant and biofilm free purified water loop from their knowledge.

3) Remedy. We’ll study participants solutions. We’ll introduce our own solutions pertaining to biofilm free purified water plant – biofilm free purified water (liquid –storage plant and loop).

4) We’ll introduce specific process to preserve production shop devices from biofilms contamination.


Continued Process Verification: how to improve your process control by acomprehensive and integrated approach?A3P Representative: Jean-Louis JouveModerators: Claire Choplin - Aktehom et Anne Rigoulot - Sanofi Pasteur

Regulatory authorities’ evolutions in terms of process validation integrate the concepts of continual improvement and knowledge management described in thedifferent ICH guidelines. Even if Annex 15 still remains the main reference for process validation, it is however no more in line with these concepts. Continuedprocess verification integrates these regulatory changes described in the Guidance for Industry (FDA), but also in the European reference (EMA). On the basis of thesenew regulations, authorities are moving towards an integrated approach of validation, based on a Quality by Design approach. This implies the identification ofcritical parameters and quality attributes to perform product and process characterization. In the case of existing products, the aim is not to question the initialvalidation but to continuously monitor, using relevant indicators, the product quality and process performance in a continual improvement objective. Regarding thisregulatory evolution, manufacturers must implement the adapted mechanisms, tools and organization to monitor and evaluate their existing or new processes.Ultimately, the purpose is to prove the process robustness by identifying sources of variability, their impact on the product quality, and to implement regularly andproactively, appropriate improvement or corrective actions. To introduce this workshop, the regulatory context and the main principles of continued process verificationwill be presented. Gains and difficulties in its implementation will be also shared. Then a pragmatic and operational implementation of continued process verificationbased on an existing pharmaceutical manufacturing process will be worked on in small groups. Finally, each group will propose an organization and a procedure toimplement this new approach. Each proposal will be commented and challenged by all participants, providing a comprehensive and practical overview of themaintenance of the state of control process (validated state).


Daily Risk Management: From identification to follow up and review on EHS / Quality& Business risks in vaccines production A3P Representative: Roland GuinetModerators: Antoine Maximillien et Francis Leclercq - GSK Saint Amand

The workshop on Daily Risk Management will address several aspects: Identification of Business / EHS & Quality risks from an example about vaccines processes.Assessment: the formalization and the way to proritize will be treated, with risks identified from the example and the method to calculate their scoreRemedial actions: root cause analysis tools will be used in order to identify the appropriate actions to be implemented with for example, root cause analysismethodology and the tool “5 why”.Follow up and review: examples of operational management tools such as Risk register and Key Performance Indicators (KPIs) will be developed.


“Quality by Design” for the management of pharmaceutical water using loopsA3P Representative: Hervé TasseryModerators: Samah Ringa - BWT Permo et Robert Neri - Sanofi

The objective of the workshop is to apply the approach of "Quality by Design" (ICH Q8) to an installation of water production for pharmaceutical use. This will bedeployed for optimal mastery of the installation. Particular attention will be paid to the following points: Qualifications: from design to performance measurement,The conduct of everyday facilities (monitoring, log book, preventive maintenance... etc), The management of microbial contamination (flora card, microbiologicalmonitoring, treatment results "Out Of Specifications" biofilm and disinfection).The purpose of this workshop is to realize that the implementation and monitoring of a water facility for pharmaceutical use should be discussed with methodology.The goal is to understand all aspects of management time and resources, to identify the key steps to consider the technical aspects of design, qualifications andmonitoring of water pharmaceutical use.After a review of the regulatory framework, the steps followed by a draft of a water facility for pharmaceutical use and the main techniques of water treatment,participants will work on a specific case of processing water system design from the drafting of specifications to performance qualification.They will also discuss a case of microbial contamination.They will be invited to set up a rational investigation and will establish a working document to process results OOS approach.Following this work in small groups, a restitution and a summary of work in the form of a flow chart will be presented.An area for debate is also expected in order to address topics suggested by the participants themselves during the sessions.

Workshops

6


Non-destructive headspace oxygen monitoring

Rapid non-destructive lyo moisture determination

www.lighthouseinstruments.com

Laser-based headspace analysis for:

100% container closure integrity testing

WORKSHOP N°10

Single use systems in routine production, advantages and drawbacksA3P Representative: Patrick TurlierModerators: Georg Roessling - PDA et Olivier Boizet - GE Healthcare Life Sciences

1 - PDA Technical Report Single Use Systems Summary (incl. overview of the technology).2 - Technical aspects in relation to QbD and qualification.3 - Single Use System from the clinical trial manufacturing in view of the commercial product.4 - Regulatory aspects and suppliers agreements.5 - Economic aspects and risks.


How to implement a matrix approach for the performance qualification of anautoclaveA3P Representative: Patrick Hibon de FrohenModerators: Thomas Pothier - Récipharm et Damien Poupry - Qualis Expertise

Qualification/Validation teams are frequently faced with a multitude of formats to qualify.The goal of this workshop is to think about validation strategies by sharing experiences.The case study will be based on Recipharm and Qualis Expertise’s experiences. Recipharm and Qualis Expertise participated in the implementation of a sterile orfinal aseptic filling line for 2 ml to 100 ml vials. The aim of the workshop is to define validation strategy to optimize qualification runs.This thought is about three types of load: - porous load (stopper), - no porous load (material), - liquid load (finished product).The workshop’s participant will work on the best validation/qualification approach in line with BPF/cGMP.

20h00 Exclusive and unique Gala Dinner

Workshops Biarritz 2013




In 2012, the 25th International Congress A3P receiveda Commercial Events Certification by the Institut Infora

Lectures

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Thursday October 17th

Congrès A3P

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915 visites de

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589 m²

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8h00 Welcome to the participants at the Bellevue Space

9h00 Process development and manufacturing: Single Use versus Glass and Stainless Steel Laure Valognes - Merck Biodevelopment

9h30 Innovative raw material management and product design strategy for enhanced quality, assuranceof supply, validation & change control of single use systemsJean-Marc Cappia - Sartorius Stedim Biotech

10h00 Single-use: the right choice for “Fill & Finish” applications?Florelle Tourlet - Octapharma


11h30 New regulatory framework for Cell and Gene TherapyIsabelle Pautrel - CELLforCURE - Groupe LFB

12h00 Control criteria of class A/B for filling processes with terminal sterilisation Julien Triquet - GSK

12h30 Lunch

14h00 ROUND TABLE:

• Systems Ready To Use (RTU) / Single Use (SUS) for aseptic pro-cesses: what are the consequences for the product quality (particles,leachables, relargables, others) and on sterility assurance (verifica-tion of the integrity of sterilized materials at the point of use) ?

• Modification of Annex 1: the last version dated 2008 includes somepoints to correct and some others to better explain. New require-ments could also probably be proposed in order to include all currentaspects.

Under the supervision of Jacques Navellou (A3P) each topic will be discussed during around onehour after a short introduction indicating some pending questions (Roland Guinet, RGmpCompliance, A3P). The discussion will include experts on each topic either end users, speakers orworkshop leaders at the congress or ex members of NRA. The possible experts include for RTU:SUSDominique Sierakowski (Octapharma, A3P), Anne Rigoulot (sanofi pasteur, A3P) et Georg Roessling(PDA Europe) and for the revision of Annex 1 Jean-Denis Mallet (NNE Pharmaplan), Patrick Turlier(GSK, LEEM quality leader, A3P) and Frédéric Laban (Laban Consultants). You will be able to raiseany question either during the discussion or by communicating to the Organising Comitee beforethe round table.

16h00 End of the A3P Congress 2013

Biarritz 2013



It’s still possible to take part as an exhibitor, please contact Sophie Cornu at 33(2) 38 071 071 or on [email protected] LIST TO DATE:5M PARTNER 63AAF 56ACM PHARMA 50AFTON SCIENTIFIC 37ALTRAN 105AMILABO 41APTAR STELMI 83ARECO 116ASSOCIATE OF CAPE COD 51-52AWEL INTERNATIONAL 42BATIMPRO 34BAUSCH ADVANCED TECHNOLOGYGROUP-BAUSCH SWITZERLAND 106BCMI Guide de l'Ultra Proprete Kiosque 10BECTON DICKINSON C8BELIMED 67BIION 111BIOMERIEUX 92-93BIOPRACTIS TRAINING CENTER 33BIOQUELL 88-89BLEZAT C4BRUNO COURTOIS SA 66BURKERT CONTROMATIC SAS 20BWT PERMO 91CHARLES RIVERS 102-103COFELY AXIMA 43COMECER 86CONFARMA 13CONTEC INC 16DISPOSABLE LAB 5ENNOV 109

ERMAFLUX 36EUROFINS 32FURNESS CONTROLS 9GE MEASUREMENT & CONTROL 55GEA LYOPHIL 44GERFLOR 30GETINGE 107GRONINGER & CO 11ICARE 64IMA France 112INENTECH 46INITIAL SAS 45INTERTEK 85JB TECNICS-Groupe JBT C1JCE BIOTECHNOLOGY 100-101KIMO 31LABORATOIRES ANIOS 15LABWARE 118LAPORTE EURO 114LIGHTHOUSE INSTRUMENTS 65LONZA 94MERCK MILLIPORE 17-18METTLER TOLEDO ANALYSE INDUSTRIELLE 61MICROSCAN SERVICE 117MRB Automatismes Industriels C7NNE PHARMAPLAN 104NOVATEK INTERNATIONAL C3OPTIMA PACKAGING France 95PALL LIFE SCIENCES 60-90PAMAS 14PARKER HANNIFIN 7

PHARMTEC 53

PIERCAN C9-C10

PIERRE FABRE MEDICAMENT PRODUCTION 108

PLUMAT 96

PMT France 40

ROBERT BOSCH GmBH 19

ROMMELAG AG 6

ROVI CONTRACT MANUFACTURING 54

SAPIC C11

SCHOTT AG 97

SCHREINER MEDIPHARM 98

SCHULKE France 84

SGS LIFE SCIENCE 99

SHIELD SCIENTIFIC 35

SKAN AG 12

SNDI ELIS 68-82

SOPAC 8

STERIGENE 69-70

STERILINE 10

STERIS SA C5-C6

SWAN 113

SYMBIOSE ENVIRONNEMENT 110

TECHNIP 62

TELSTAR 87

VAISALA 115

VEOLIA WATER STI 71

WILCO AG C2

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Exhibition

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ACCUEIL

STAND LIBRE

STAND RÉSERVÉ 15-17 octobre 2013 à BiarritzExhibition mapFree space

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A3P has selected hotels for you.Best prices have been negociated by A3P,included room and breakfast.Find the reservation file on www.a3p.org withthe selected hotels.We built a partnership with «TourismeBasque» which will help you with yourbooking ;

the partner Agency will be pleased to advise you on your choise.

24, avenue Foch – 64200 BiarritzTél. : 05 59 24 01 10 - Fax : 05 59 26 18 82Mail : [email protected]

Appointments 2014!Do not miss it! Vinci Congress Centre in Tours, France.The biennial meeting of microbiology. The "Workshops" organized with the partnercompanies will review various existing alternative techniques and present several devices.Conferences - Workshops - Exhibition.

18th & 19th

March

Pa r t i c u l e sv i s i b l e sv i s i b l e sPa r t i c u l e sv i s i b l e sPa r t i c u l e sPa r t i c u l e s

Particulary interesting! “Pavillon des Aulnes” in Vaudreuil - France.The presence of particles of different natures endogenous intrinsic or extrinsic is a concernfor all industrial producing parenteral products. Presentation of the progress of the A3PInterest Group (CIG A3P).Conferences - Workshops - Round Table - Exhibition.

2nd

July

Freeze Drying meeting! “Espace Tête d'Or” in Lyon - France.Second year around the Freeze drying with a refund of the work of the A3P Interest Group(CIG A3P) and always a visit of a production site.Conferences - Workshops - Round Table - Exhibition.

1st & 2nd

April

Now it is a convention! “Espace Tête d'Or” in Lyon - France.Lecture of experiences upstream downstream from opinion biotechnology leaders andinteractive workshops.Conferences - Workshops - Round Table - Exhibition.

3th & 4th

June

Already thinking about 2014! Bellevue Congress Hall, Biarritz- France.A date, a place for sharing this unmissable moment for the professionals of Pharmaceutical industry and Biotech.Conferences - Workshops - Round Table - Exhibition.

14th to 16thOctober

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Pour plus d’informations : A3P Formation - Tél. +33 (0)2 38 071 071 - E-mail : [email protected] - www.a3p.org

Note in your agenda for your french speaking people and partners some training sessions !

17 septembre 2013Comment bâtirun programme debio-nettoyagedes Salles Propres enenvironnement GMP ?Animateur :Frédéric LabanLaban ConsultantsLieu : Novotel Paris BercyDurée : 1 journée (8h30 - 17h30)

18/19 septembre 2013Développerses connaissancesdans le domainede la lyophilisation

Animateur :Dominique Sierakowski OctapharmaLieu : Novotel Paris BercyDurée : 2 jours (8h30 - 17h30)

27/28 novembre 2013L’annexe 1 des GMP Eu les points critiques,leur analyse etleur interprétation

Animateurs :Frédéric Laban - Laban ConsultantsRoland Guinet - RGmp ComplianceLieu : Novotel Lyon La Part DieuDurée : 2 jours (8h30 - 17h30)

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Benefit from Altran’s two-foldexpertise in medical devicesand pharmaceuticals to developyour combination products.

Join Altran’s conference on Tuesday 15th October

For more information, please contact Mr. Xavier Duburcq, Global Business Development Director:

[email protected]

altran.com

Documents

International Congress 1263