C.I.G (Common Interest Groups)

The CIG (Common Interest Groups) aim to bring together manufacturers and suppliers (pharmaceutical and biotechnology sectors) to share practices and questions. An ICG A3P must advance the issues presented. The members of the GIC will carry out a collaborative work around the same theme and will return it during an A3P event or through publications (the magazine La Vague, scientific and technical guide ...).

Objectives & achievements of the different CIG

Objectives
  • Following the publication on February 19, 2020 by the PIC / S and the EMA of the new version of Annex 1, the GIC Annex 1 created in 2015 (as part of the submission for comment of the “Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice - manufacture of sterile medicinal products ”(issued by the EMA in 2015) has been reactivated.

Achievements

September 2015: Creation of an article in La Vague magazine:

March 2018 : Comments submitted on the draft «Annex 1: Manufacture of Sterile Medicinal ProductsFrom the EMA

April 2018: Creation of an article in La Vague magazine:

March 2018 : The Wave article: EU Annex 1 draft: GIC A3P Proposals Appendix 1

January 2019: Creation of an article in La Vague magazine:

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Antoine AKARLSP2Olivier CHANCELBOEHRINGER INGELHEIMEric HURTUBISEVALIDAPRO
Sophie AMADIOLILLY FRANCEPierre DEVAUXTHERAXEL – POINT FORTY FIVEGuy KASDEPKA PHARMASTER
Patrick BALERIAUXASEPTIC TECHNOLOGYJean-François DULIERE ISPEJonnathan TAFFORINA3P
Marc BESSONMB-GMP COMPLIANCEWalid EL AZABSTERISJulien TRIQUETGSK
Nicolas BOURGEOISGSK VACCINESSandrine FAVREOCTAPHARMAEric VALENTIPIERRE FABRE
 Lydia BRETEAU LABORATOIRES BOIRON John HARGREAVES JHCONSULTANTS Dominique WEILL DOWELI
Objectives
  • GIC Cloturé
  • Review of draft regulatory texts
  • Preparation of questions on unclear or poorly understood points, so that they can be submitted to the health authorities to initiate discussions
  • Explain approved regulatory texts (production of a guide distributed throughout the sector)
Achievements

October 2016: Response to the public consultation on “Guidance on the sterilization of the medicinal product, active substance, excipient and primary container: EMA / CHMP / CVMP / QWP / BWP / BWP / 850374/2015”

November 2017: Publication of an A3P Scientific and Technical guide: “Control of supplier risks and cross-contamination, studies and summary of EU-GMP regulatory developments Part1 Chap. 3 and 5 ”

Discover the guide

GIC members
Objectives
  • GIC Active since September 2018
Achievements

March 2019: Creation of a questionnaire to publish a guide on the implementation of Continued Process Verification (CPV) or On-going Process Verification (OPV)

Discover the questionnaire

July 2019: Production of articles in the magazine The Wave:

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Guillermo José ALBANESISANOFI PASTEURValerie HERONSANOFIDaniel PIALOT
Michel ARNALNANOBIOTIXMichel HERTSCHUHAKTEHOMJulie RACAUDLABORATOIRE AGUETTANT
Stephane COULEEPIERRE FABRE MEDICAMENT PRODUCTIONDominique MONTPIEDSANOFI PASTEURMarie RODRIGUEZMERCK
Fabien DAHURONBIOMERIEUXMarinette MOREAUVETOQUINOLRomy SALVADORTEOXANE
Sabrina GALLAYASPEN NOTRE DAME DE BONDEVILLEAlain NONNLILLY FRANCEEstelle SCHUHLERLFB BIOMEDICAMENTS
Vincent GRIFFOULA3P SUISSEMurielle PERNELLILLY FRANCEMarguerite TULLISTRATEGIE SANTE
Objectives
  • CIG Active
  • This group is working on the topic of pharmaceutical waters in order to allow the various industrialists concerned to discuss these issues, and to reach common consensus in order to facilitate the implementation of this guideline
Achievements

May 2019: Response to the public consultation of the draft issued by the EMA entitled: "Guideline on the quality of water for pharmaceutical use

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Christian COLLETBECKMAN COULTERGuillaume LEDOUXEUROFINS PHARMA QUALITY CONTROLMarie-Laure REMEZYEAU-DI-C
Pierre CULLMANNBWT FRANCEMickael MALLENSANOFI PASTEURSamah RINGASUEZ
Michael DE HOVREGSK VACCINESFrédéric MONNIERVEOLIA WATER STIBrice ROBOLLABORATOIRE ICARE
Guy KASDEPKALABORATOIRES PHARMASTERAurélien PERIQUETOCTAPHARMADominique WEILLDOWELI
Objectives
  • CIG Active
  • In view of ongoing developments in technologies and data "delivery" methods (Cloud, mobile computing, etc.), the aim of the CIG's work is to optimize current methodologies to retain flexibility and control in keeping with the risks involved
  • Preparation of a workshop for the A3P Biarritz 2020 congress
Achievements

July 2016: Realization of a practice notebook: Evaluation of suppliers in SI (Computerized Systems)

June 2017: Exchange day in Lyon

April 2018: Production of articles in the magazine The Wave:

April 2019: Exchange day in Lyon

January 2020: Response to WHO request for comment on its draft data integrity guideline (QAS / 19.819 GUIDELINE ON DATA INTEGRITY)

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Aymeric BEAUSSANTUCB FARCHIMAurélien DUJARDINASPENLionel PELLETIERAKTEHOM
Fouad BENAMIRAUCB BESébastien GIRARDEUROTHERM BY SCHNEIDER ELECTRICThierry PETRUCCICVO EUROPE
Ali BENRAHOUBIOMERIEUXJean-Louis JOUVECOETICSylvain PLAGELLATMERCK
Denis BOUTEILLEEKIUMMichèle LAFAYPIERRE FABRE INGENIERIEPierre-François SAMBRONICYRNOS CONSEIL
Hervé CLUZEAUDASSYSTEM CAREDamien LANDOUARDNORGINE PHARMAAnne-Laure SOURDOTADHEX PHARMA
François CROIZETCEVA SANTE ANIMALEMarielle LE LOUARNVIRBAC
Eric DEVRETONBOEHRINGER INGELHEIM SANTE ANIMALEPascale MOSNIERLABORATOIRES SERVIER
Objectives
  • CIG Active
  • This group is working on the new text of the EMA on sterilization: Guideline on the sterilization of the medicinal product, active substance, excipient and primary container.

The 2 main goals are:

  • As a first step, review the draft of this text and send comments to make it evolve
  • In a second step, after its publication, to help the industrialists to understand it in order to respect it
Achievements

March 2017: Day 1 Day 1 Lab

October 2018: Response to the public consultation on the “Guideline on the sterilization of the medicinal product, active substance, excipient and primary container”

November 2019: Following the distribution of the final text, production of an article in La Vague explaining certain points

January 2020: Creation of an article in La Vague magazine:

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Peggy AUNEYBECTON DICKINSON MEDICALPhilippe LE GALLAPTAR STELMIJulien TRIQUETGSK
Jacqueline BESSETASSYTEM CAREJulie RACAUDLABORATOIRE AGUETTANTDominique WEILLDOWELI
Dominique DISSLILLY FRANCEJean-Luc REGAUDIESANOFI R&D
Walid ELAZABSTERISJonnathan TAFFORIN
Objectives
  • GIC Active since July 2018
Achievements

November 2018: Response to the public consultation on the ICHQ12 Guideline "Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management" at the EMA

September 2019: ICHQ12 exchange day in Lyon

January 2020: Production of articles in the magazine The Wave:

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Meriem ABADAUNION PHARMACEUTIQUE CONSTANTINOISEMaëlle DESREUMAUXASSYTEM CAREAnne RIGOULOTSANOFI
Olivier ANTOINEBOIRONAminata DIAGNEINSTITUT PASTEUR DE DAKARSabine SARBACH DETOLLELABORATOIRES SERVIER
Nadia BEAUDOUXLILLY FRANCEDelphine FORNASLABORATOIRE AGUETTANTSandrine SEGURABLUEREG PHARMA CONSULTING
Isabelle BOSQBOEHRINGER INGELHEIM SANTE ANIMALEStéphanie JABYLFBLisa SMITH-FAUVELNOVO NORDISK PRODUCTION
Frédérique CHAZOTPATHEON FRANCEAurélie MIEZE-RICHARDGUERBETCatherine ZUNEGSK VACCINES
Katia CHOHBANESANOFI PASTEURMireille PEYRACIPSEN PHARMA BIOTECH
Sylvie COTTAVOZINSTITUT DE RECHERCHE PIERRE FABREJohanne PIRIOUAKTEHOM
Objectives
  • CIG Active
  • Draft on best practices for heat mapping in lyphilization
  • The group working on the day A3P lyophilization 4th July 2019
Achievements

In 2013: Exchange day

April 2014: Exchange day

June 2015: Exchange day

October 2017: Exchange day in Lyon

July 2019: Exchange day in Lyon

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Sylvain BATIONBIOMERIEUXBenoit MOREAUGSK VACCINESDominique SIERAKOWSKIDS ASEPTIC COMPLIANCE
Vincent BIGEARDVIRBACCharles NODOTELLABDenis TIXIERAMPHENOL SENSORS
Laurent EUZETPIERRE FABREPaul POULAINLIVES INTERNATIONAL
Objectives
  • CIG Active
  • This group first of all makes it possible to draw up an inventory of the methods proposed, envisaged, evaluated, adopted and rejected by all the laboratories of the industrialists of the pharmacy with their proven advantages and disadvantages.
  • This group is currently working on creating a validation guide
Achievements
GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Alexis BILLARDSTALLERGENESHugues DESREUMAUXGUERBETEric PETATACM PHARMA
Gaëlle BISCHGENOSCREENMargaux EISSALDEL’OREALLucile PLOURDE OWOBISANOFI PASTEUR
Hélène BLONDELSANOFISoria HAMDAOUICONSULTYS RAMehdy RATAJCZAKASPEN
Thierry BONNEVAYSANOFI PASTEURLaurent LEBLANCBIOMERIEUXPhilippe TAILLIEZACM PHARMA
Arnaud CARLOTTIEUROFINS IDMYKFélix MONTERO JULIANBIOMERIEUX
Ludovic CHAMPIEREUROFINS BPTThierry MULLERMERCK
Objectives
  • Inactive GIC
  • Technical guidelines on visible particle control drafted jointly between manufacturers and suppliers
  • The 10 golden rules of visual inspection
Achievements
Objectives
  • CIG Active
  • This group aims to provide a practical and technical guide to demystify the concepts presented in the regulation such as the establishment of the QTPP (Quality Target Product Profile), the definition of critical process parameters and critical quality attributes of the product and the "design space" to develop and validate a robust and capable process with an effective and adapted control strategy
  • This GIC will be complementary to the GIC "CPV Continued Process Verification" and "statistical methodology for the comparative assessment of quality attributes in development"
Achievements
Members of the gic
Last nameCompanyLast nameCompanyLast nameCompany
Pascal AUTHOUARTORIL INDUSTRIEVincent GRIFFOULA3P SUISSEAline MOULINSKYEPHARMA PRODUCTION
Juan BERNALSTALLERGENESArlette KANTEVETOQUINOLLaure PLANCHEFAB ENTECH
Aude COLINDEBIOPHARM INTERNATIONALElodie KEROMNESLONZAAnne RIGOULOTSANOFI
Marie-Anne COLOCOURISGSK VACCINESStephan KOPYLAVIRBACSandrine SEGURABLUEREG PHARMA CONSULTING
Sylvie COTRETNUVISAN FRANCECédric LE BARHSANOFIStephane VARLETPROCTER & GAMBLE
Nathalie DALLYALLERGAN INDUSTRIERomain LE DEUNMERCKBenjamin VITRATFERRING INTERNATIONAL
Sandrine DUCLOSCOPHACLEANFlorent MAESTRACCIAKTEHOMLinda YAHIAOUIASSYTEM CARE
Delphine FAYOLPOETISSabine MIGNOTBIOM UP
Objectives
  • Establish a guide for manufacturers on the deployment, use and maintenance (Life Cycle Management) of single-use solutions
  • Realize an overview of the key issues of the SUS: validation, environmental impact, integrity test, extractables / relarguables ...
  • Develop a collaborative platform between users and providers, in order to anticipate changes and work jointly on shared standards
  • Promote technical solutions using closed systems and containment systems for toxic products
  • Creating an interactive tool
Achievements
GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Sébastien BARRYSANOFI PASTEURCéline GUERNIERLFB BIOMEDICAMENTSCamille PERQUINTEOXANE
Vincent BECHTELLONZAValérie KANDELLILLY FRANCEPriscille PINGAULTAKTEHOM
Jean-Louis BELMONVIRBACAurélie LABOURIERRECIPHARMMarine ROUSSETTECHNIP FMC
Mehdi BOUKAMIMERCKOlivier MANCHONASPENVéronique TABONEVERDOT IPS2
Elodie CAPPONIPALL BIOTECHChristelle MARCOUXGSK VACCINESJérome TORRESASEPTIC PROCESS EQUIPMENT
Patrice COUMETTECHNIP FMCEva MASSONCELL FOR CURELaurence VAN ESPEN-BOONENUNIVERCELLS
Brigitte DELAPLACECharlotte MASYGSK VACCINESFrançois VANHERSECKEGSK VACCINES
Camille DESROUSSEAUXTHERMO FISHER SCIENTIFICKatell MIGNOTSARTORIUS STEDIM FMTPhilippe WAGHEMACKERSANOFI PASTEUR
Eric DEVRETONBOEHRINGER INGELHEIMJean-Philippe MINNEPARKER HANNIFIN
Olivier DUPUISLFB BIOMEDICAMENTSJacques NAVELLOUAXYS NETWORK
Objectives
  • GIC Active since October 2017
  • The group has commented on the Guideline "Guidance on 'Reflection Paper on Statistical Literacy for Comparative Assessment of Quality Attributes in Drug Development (EMA/CHMP/138502/2017)"
  • The group took part in the EMA workshop in May 2018 on "Guidance on 'Reflection Paper on Statistical Methodology for Comparative Assessment of Quality Attributes in Drug Development' (EMA/CHMP/138502/2017)"
Achievements

March 2018: Response to the public consultation on the Guideline "Guidance on 'Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development' (EMA / CHMP / 138502/2017)"

July 2019: Production of articles in the magazine The Wave:

GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Meriem ABDENNOURSANOFI PASTEURMourad MELLALGSK VACCINESAnne RIGOULOTSANOFI
Sébastien LE GUILLOUASPENMarinette MOREAUVETOQUINOLCatherine TUDALSOLADIS
Caroline LEVEDERSANOFIAlice RAILLARDSANOFI
Objectives
  • CIG Active
  • Preparation of A3P Days Barrier Technology for March 2019
  • Sharing validation standards, maintenance standards and operational standards relating to the use of barrier technologies, incorporating international guidelines (ISPE 2005, PHSS 2010) and in keeping with the likely positions of the further GMP Annex 1
  • Inventory of the different "Barrier Technology" solutions on offer and identification of any unmet needs
  • Suggested guidelines (operator training, quality control and use of gloves, etc.)
Achievements

March 2015: Jexchange days in Pau

January 2017: Creation of an article in La Vague:

March 2017: Exchange days in Pau

March 2019: Exchange days in Pau

Members of the gic
Last nameCompanyLast nameCompanyLast nameCompany
 Franck ARETHUSEPIERCAN Eric GOHIERJCE BIOTECHNOLOGY Sébastien RENOUFLFB BIOMEDICAMENTS
 Céline AUXENFANTSHOPITAL EDOUARD HERRIOT Etienne HEMBERTLILLY FRANCE Florelle TOURLETOCTAPHARMA
Marc BESSONMB-GMP COMPLIANCE Pascal HILDCENTRE HOSPITALIER ROANNE Julien TRIQUETGSK
Patrick COPPENSLABORATOIRES MSDSerge LA SPINAGSK VACCINESEric VALENTIPIERRE FABRE MEDICAMENT PRODUCTION
 Philippe DUTOTNOVO NORDISK PRODUCTION Laurent LAGANIERHOPITAL NECKER APHP Julie VERANASSITANCE PUBLIQUE – HOPITAUX DE MARSEILLE
 Nicolas FERRYNF CONSULTING Didier MEYERDMCOMPLIANCE
 Laurent FLUHRSKAN Cyril MOUNIERGETINGE – LA CALHENE
Objectives
  • CIG Active
  • New Annex 15 applicable from 1er October 2015: draft a reading guide and draft a Master Validation Plan for use as a template
  • Review regulatory texts relating to Cleaning and existing international guidelines
  • Propose template strategies for:
    - researching source data used for computing PD values
    - integrating these values for computing acceptance criteria
  • The group has produced a guide
  • Preparation of 2020 Cleaning Validation Days
Achievements
GIC members
Last nameCompanyLast nameCompanyLast nameCompany
Margaux ARTHUSBAUSCH & LOMB/CHAUVINMarion DUMONTCHRISTEYNSJulie RACAUDLABORATOIRE AGUETTANT
Sophie BOURGOISASPENFrançoise DURANDLABORATOIRES ANIOSThomas ROHAUTAKTEHOM
Maryse CORROLLERCEHTRAGuillaume GARREAUGSK CONSUMER HEALTHCAREEmilie SOLLIERSANOFI PASTEUR
Alexandre DE NEEFGSK VACCINESIsabelle GONZALEZTEOXANEDavid UGOLINIUPS CONSULTANTS
Pierre DEVAUXTHERAXEL POINT FORTY FIVESolenn JANVIERPIERRE FABRELaurianne ZUCHUATVIFOR
Marilyne DOUEZNOVO NORDISK PRODUCTIONMarie-Véronique MUNERELVIRBAC
Sandrine DUCLOSCOPHACLEANJean-Baptiste NOIROT COSSONMERCK

Head of CIG

For questions regarding CIGs, please contact Victoria PALOMBI:

By phone at +33 (0)4 37 28 30 53 by email to vpalombi@a3pservices.com