The GIC (Common Interest groups)

The G.I.C (Groupes d'Intérêt Commun - Common Interest Groups) aim to bring together manufacturers and suppliers (pharmaceutical and biotechnology sectors) to share practices and questions. An A3P GIC 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 (La Vague magazine, scientific and technical guide ...).

OBJECTIVES & ACHIEVEMENTS OF THE VARIOUS GIC

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 Products» from the EMA

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

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

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Closed GIC
  • 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

Members of the GIC
Objectives
  • Active GIC 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 La Vague Magazine:

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC
  • 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”

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC
  • 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 2020 A3P Biarritz Congress
Achievements

July 2016 : Realization of a practice notebook: Evaluation of suppliers in IS (Information Systems)

June 2017 : Exchange day in Lyon

April 2018 : Production of articles in La Vague magazine:

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)

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC
  • This group is working on the new text of the EMA on sterilisation: Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container.

The 2 main goals are:

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

March 2017 : 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:

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC 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 La Vague magazine:

Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC
  • Draft on best practices for heat mapping in lyphilisation
  • The group is working on the A3P Lyophilisation Day of 4th July 2019
Achievements

2013 : Exchange day

April 2014 : Exchange day

June 2015 : Exchange day

October 2017 : Exchange day in Lyon

July 2019 : Exchange day in Lyon

Members of the GIC
NameCompanyNameCompanyNameCompany
Sylvain BATIONBIOMERIEUXBenoit MOREAUGSK VACCINESDominique SIERAKOWSKIDS ASEPTIC COMPLIANCE
Vincent BIGEARDVIRBACCharles NODOTELLABDenis TIXIERAMPHENOL SENSORS
Laurent EUZETPIERRE FABREPaul POULAINLIVES INTERNATIONAL
Objectives
  • Active GIC
  • 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
Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC
  • 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
NameCompanyNameCompanyNameCompany
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
  • Establishing a guide for manufacturers on the deployment, use and maintenance (Life Cycle Management) of single-use solutions
  • Realizing an overview of the key issues of the SUS: validation, environmental impact, integrity test, extractables / relarguables …
  • Developing a collaborative platform between users and providers, in order to anticipate changes and work jointly on shared standards
  • Promoting technical solutions using closed systems and containment systems for toxic products
  • Creating an interactive tool
Achievements
Members of the GIC
NameCompanyNameCompanyNameCompany
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
  • Active GIC since October 2017
  • The group 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 La Vague magazine:

Members of the GIC
NameCompanyNameCompanyNameCompany
Meriem ABDENNOURSANOFI PASTEURMourad MELLALGSK VACCINESAnne RIGOULOTSANOFI
Sébastien LE GUILLOUASPENMarinette MOREAUVETOQUINOLCatherine TUDALSOLADIS
Caroline LEVEDERSANOFIAlice RAILLARDSANOFI
Objectives
  • Active GIC
  • Preparation of A3P Barrier Technology Days 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 : Exchange days in Pau

January 2017 : Creation of an article in La Vague magazine:

March 2017 : Exchange days in Pau

March 2019 : Exchange days in Pau

Members of the GIC
NameCompanyNameCompanyNameCompany
 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
  • Active GIC
  • New Annex 15 applicable from 1er October 2015: draft a reading guide and draft a Master Validation Plan for use as a template
  • Reviewing regulatory texts relating to Cleaning and existing international guidelines
  • Suggesting 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
Members of the GIC
NameCompanyNameCompanyNameCompany
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

Supervisor of the GIC

For any questions regarding the GICs, please contact Victoria PALOMBI:

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