The Common Interest Groups - CIGs

The CIGs (Common Interest Groups) aim to bring together manufacturers and suppliers (pharmaceutical and biotechnology sectors) to share practices and questions. An A3P CIG must advance the issues presented. The members of the CIG 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 ...).

SHARING-CIG

OBJECTIVES & ACHIEVEMENTS OF THE VARIOUS CIG

Objectives & Achievements

Since August 22, 2022, the new version of the Annex 1 text of the EU GMP has been published. The members of the A3P Annex 1 working group (GIC) will continue their analysis work and share their experiences with the network. (Annex1 GMP EU 2022 .pdf)

  • Dec. 2022: Publication of the A3P Annex 1 CCS GUIDE (pdf in the A3P member area)
  • Oct. 2022 & 2021: Annex 1 Conferences & Workshops at the A3P International Congress (pdf presentations in the A3P member area)
  • Jul. 2020: Comments submitted on the draft “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) to the EMA
  • Jan. 2019: Article La Vague: A3P International Congress 2018: Key messages from the round table on the revision of Annex 1.
  • Mar. 2018: Article La Vague: EU Annex 1 draft: Proposals from the A3P Annex 1 GIC
  • Apr. 2018: Article La Vague: EU Annex 1 draft: Proposals from the A3P Annex 1 GIC
  • Mar. 2018: Comments submitted on the draft “Annex 1: Manufacture of Sterile Medicinal Products” by the EMA
  • Sept. 2015: Article La Vague: Specific proposed amendments to Annex 1.
Members of the CIG
NomSociétéNomSociétéNomSociété
Antoine AKARHUMANIMBenoit FRANQUINCSL BEHRINGSophiane NAILIIPSEN
Marc BESSONAXYS NETWORKFrançois GUILLOUDELPHARMNicolas RESTENCOURTSANOFI
Nicolas BOURGEOISSANOFIChristophe HAENTZLERGSKEmna SLAMASYNEXIN
Lydia BRETEAULABORATOIRES BOIRONJohn HARGREAVESJHACJonnathan TAFFORINA3P ASSOCIATION
Elodie DECONINCKGSKIsabelle HOENENLILLYJulien TRIQUETCSL BEHRING
Pierre DEVAUXTHERAXELEric HURTUBISEVALIDAPRODominique WEILLDOWELI
Jean-François DULIEREISPEGuy KASDEPKAPHARMASTERJérôme WEISZNOVONORDISK
Walid EL AZABQP PRO SERVICESVirginie LEFERELILLY
Sandrine FAVREOCTAPHARMALucile LIEGARDRECIPHARM
Béatrice FOURNIEASPEN PHARMAVirginie MARTINONBOEHRINGER INGELHEIM
Objectives & Achievements

The complexity and diversity of aseptic processes require adapted Barrière Technology solutions for each of them. The work and sharing of good practices by the members of the CIG are intended for professionals in order to optimize their production process by integrating the requirements of Annex 1 and international recommendations (ISPE, PHSS, PDA, ..).
This group is currently working in 2024 on the following 4 subjects: study on holes in gloves, the various innovations linked to barrier technologies (RTP, Biotrak, VHP, etc.), routine production under ISO or RABS, and Annex 1 (first air, smoke studies, etc.) and plans to write articles or practical guides. The group also provides qualifying training to people in the industry, example below for the visual inspection of gloves under isolator.

June 2025: Technical days (conferences) Location to be defined
June 2023: Technical Days (conferences) in Tours
September 2021: Technical Days (conferences) in Tours
October 2020: Creation of an article in La Vague: The campaign is winning! Working in campaign mode, a step forward in the productivity of insulators.
November 2019: Creation of a practical training module: Visual inspection of gloves and cuffs under isolator
March 2019: Technical Days (conferences) in Pau
March 2017: Technical Days (conferences) in Pau
January 2017: Creation of an article in La Vague: Secure the confinement of your gloves
March 2015: Technical Days (conferences) in Pau”

Members of the CIG
NameCompanyNameCompanyNameCompany
Franck ARETHUSEPIERCANEdith FILAIREGROUPE ICARECyril MOUNIERGETINGE – LA CALHENE
Léa AVERTINDELPHARMLaurent FLUHRSKANJules MOUSSATOFFTAKEDA
Marc BESSONAXYS-NETWORKEric GOHIERJCE BIOTECHNOLOGYAudrey SCHULTZNOVO NORDISK
Pascal CHAMPAGNATAXYS-NETWORKEtienne HEMBERTLILLY FRANCEFlorelle TOURLETOCTAPHARMA
Patrick COPPENSISOTECXELPaul MARNATSANOFIAntoine TOUSSAINTGSK VACCINES
Ludovic DEMOORLFBDidier MEYERDM COMPLIANCEJulien TRIQUETCSL BEHRING
Alain DESERTEREAGuillaume MOLLANDINLONZAYoann VANELAVN
Objectives & Achievement

In a context of increasing health authority requirements regarding BFS (Blow-Fill-Seal) technology and the growing demand for vaccines, it is crucial to understand all the necessary steps for filling injectable solutions, to grasp critical parameters, and to set the sterility assurance level at an appropriate level in order to control manufacturing costs and timelines.

Therefore, A3P has decided to create a Working Group on this subject, enabling various concerned industry stakeholders to exchange information and reach common consensus. The ultimate goal is to develop a practical guide for future BFS operators who must manage this type of process, as well as to present the results of this collaborative work in various formats such as conferences and articles.

Objectives of the A3P BFS Working Group: Define a practical guide for industry professionals to understand and effectively manage this technology and its associated processes in the long term. Publication of this guide is planned for 2024.

Members of the CIG
NameCompanyNameCompanyNameCompany
Christophe BENOITROMMELAGRodolphe CHOVYTHERAXELLaury LIVEMONTUNITHER
Delphine BOIVINN/ALauriane FREYCHETFAREVA EXCELVISIONPascal LUDAESCHERRECIPHARM KAYSERSBERG
Alexandra BRIAUXBOIRONPatrick GERVAISGILBERTClaire PASTOREAGUETTANT
François CABOULETN/AMohamed HABAZATRYON
Mélissa CHEVALIERASPEN NDBMichel LE CADREUNITHER
Objectives & Achievement

The objective of the CIG is to propose a decision tree (methodology, rational) to support all projects with high added value by listing the key stages, prerequisites and points of vigilance throughout the development of a Biotherapy product .​ This guide is being written to identify in particular the issues, levers and pitfalls to avoid in the development of biotherapies.
It will be presented at the next edition of the CIG Biotherapy Processes on November 21, 2024.
November 2023: Event dedicated to Biotherapy processes to bring together the main players in the field (Start-ups, manufacturers, CDMOs, suppliers & service providers). Address the technical and regulatory issues to be considered when of the different development phases (pre-clinical & clinical) to prepare, accelerate and succeed in industrialization.

Members of the CIG
NameCompanyNameCompanyNameCompany
ANQUETIN MaximeAIR LIQUIDEHUBERT DorothéeAVANTOR VWRRIGOULOT AnneDELPHARM
BAZOT QuentinABL EUROPEJUST OlivierN/ARIOU EdwigeAKTEHOM
BELMON Jean-LouisVIRBACLE BEC ChristineSENSORION PHARMASANDER PeggyILS
CAMEAU EmmanuelCYTIVALEROY CelineNAOBIOSSLAMA EmnaSYNEXIN
CASSART AnneLSBMARZOUKI FarahPK MEDSOBCZYK AndréCHUV
CECILLE MarieMERCK CTDMOMICHEL SophieSMICHEL ConsultingVAN VYNCHT GéryQUALITY ASSISTANCE
DESNOYER MargauxALTEREGO BIOTECHMONTEMONT LionelPOLYPLUSVERHOEYE FrancisEXOTHERA
DUBOIS LucVALIDAPRONERRIERE OlivierLAPORTE EUROVIEVILLE FrédériquePHAXIAM
DURACHER DavidAMOLYTNIVAU AudreySEQUENSZIEGLER ThierryHUMANIM
EL GUEDDARI MoradYPOSKESIPLANCHE LaureFAB’ENTECH
GILON NicolasCATALENTRACHON AlainN/A
Objectives & Achievements

Since 2022, the working group has evolved to be called “Cleaning & Disinfection” in line with regulatory expectations. It continues its work for professionals in the industry.
April 3-4, 2024: Cleaning & Biocleaning event which will therefore talk about the control of surface decontamination and will return in particular to the indirect contact parts of our Barrier Technologies without forgetting the fundamentals of cleaning validation (program link).
March 2022: A3P Cleaning Validation Conference (conference available on the A3P member area)
March 2022: Practical GMP Guideline – Annex 15 Qualification & Validation Chapter 10 Cleaning Validation
June 2021: A3P Cleaning Validation Conference (conference available on the A3P member area)
June 2018: A3P Cleaning Validation Conference (conference available on the A3P member area)
July 2017: Articles published in La Vague magazine.

Members of the CIG
NameCompanyNameCompanyNameCompany
Guillaume BONNEAUNOVO NORDISKAgnès FRANCOVIRBACThomas ROHAUTAKTEHOM
Sophie BOURGOISASPEN NDBGuillaume GARREAUHALEONLaurent SIMONCOPHACLEAN
Emmanuel BLANCNOVO NORDISKSolenn JANVIERPIERRE FABREDenis STREITTECOLAB
Pierre DEVAUXTHERAXELElsa LAJUSFAREVA PAUPhilippe TAILLIEZACM PHARMA
Maryline DOUEZNOVO NORDISKEmilie LEONECENEXIMarie-Bénédicte TESSIERVETOQUINOL
Marion DUMONTCHRISTEYNSNicolas PALLUETCONTEC EUROPEAudrey THIERYDELPHARM
Stéphane DURANDCONFORMATStéphane PIERRECEHTRADavid UGOLINIUPS CONSULTANTS
Audrey FOURCADE LABEILLELFBJulie RACAUDLABORATOIRE AGUETTANTLaurianne ZUCHUATCORDEN PHARMA
Objectives & Achievements

The members of the A3P CPV Working Group aim to further develop the first version of their practical guide with recommendations for industry professionals on the conditions for starting CPV activities, its implementation, and its use (interpretation of results).

Members of the CIG
NameCompanyNameCompany
Damien BONNETPATHEON THERMOFISHERMohamed KADEMSKYEPHARMA
Véronique BRIANTO-GABIERMAAT PHARMARim KHELIFSANOFI
Stéphane COULEEFAREVA PAUSophie METTEILIPSEN
Sabrina GALLAYASPEN NDBAlain NONNALPHA PHARMA CONSULTING
Michel HERTSCHUHAKTEHOM
Audrey IMBERT-CLIGNACVETOQUINOL
Objectives & Achievements

Faced with evolving technologies and modes of IT delivery (Cloud, mobile computing, etc.), the eCompliance Working Group’s efforts aim to optimize current methodologies to maintain flexibility and appropriate risk management. Share best practices and soon present in a guide the concept of validation applied to artificial intelligence.
March 2023: A3P Digital Transformation 4.0 Conference (PDF support conferences available on the A3P member area)
January 2023: Participation in comments on the EMA GMP Annex 11 Concept Paper
January 2020: Response to the WHO’s request for comments on its draft guideline on data integrity (QAS/19.819 GUIDELINE ON DATA INTEGRITY)
April 2019: A3P eCompliance Conference (PDF support conferences available on the A3P member area)
April 2018: Publication of articles in La Vague magazine
Data Integrity: towards the establishment of Data Management
Cloud & Data Integrity Migration
June 2017: A3P eCompliance Conference (PDF support conferences available on the A3P member area)
July 2016: Publication of a practical guide on Evaluation of suppliers in IS (Information Systems)

Members of the CIG
NameCompanyNameCompany
Olivier ANTOINESANOFILoic GUYONNEMERA
Aymeric BEAUSSANTUCB FARCHIMThibault HELLEPUTEDNALYTICS
Estelle BOROWIECLILLYJean-Louis JOUVECOETIC
Hugo BOUQUETBIOMERIEUXCedric MAUNOURRIORAVIS
Laurent CLAUSSCEVAPascale MOSNIERLABORATOIRES SERVIER
Hervé CLUZEAUDASSYSTEM CARE – EXPLEOLionel PELLETIERAKTEHOM
Alexia DEVENSCHARLES RIVERThierry PETRUCCICVO EUROPE SOCIETE NOUVELLE
Jean-Sebastien DUFRASNEMITHRAElodie RAGNEGETINGE
Aurélien DUJARDINASPEN NDBPierre-François SAMBRONICYRNOS CONSEIL
Marine GUIOUASPEN NDB
Objectives & Achievements

The work of this Working Group has been completed.

Members of the CIG

Authors

  • Alexandre Drapier, Global Quality Compliance Support – GSK Vaccines
  • Sophie Michel, General Manager – Validapro
  • Lionel Montémont, Business Manager – Hedinger
  • Anne Rigoulot, Global Quality Validation Leader – Sanofi

Contributors

  • Caroline Benguerel, IPSEN
  • Stéphane Chabanon, MSD
  • Marie Lamothe, Pierre Fabre
  • Ineke Nackaerts, UCB Pharma
  • Anthony Olivier, Laboratoires Aguettan
  • Karine Vergnaud, Delpharm
  • Ornella Binazon and Etienne Michel, GSK Vaccines

Acknowledgments

  • AFMPS, for hosting us in their premises and dedicating 2 hours to answer our questions. Special thanks to: Jean-Luc Golnez, GMP inspector participating in a working group on Chapters 3 & 5; Aurélie Pol, GMP inspector; Sébastien Herman, GMP inspector trainee; Ahian Zouhir, GMP inspector trainee.
  • ANSM, MHRA and SWISSMEDIC for kindly answering our questions during the conferences.
  • IPEC Europe, and particularly Dr. Frank Milek, President of IPEC Europe.
Objectives

The creation of an CIG on Environmental Performance responds to a growing awareness of the ecological impact of the pharmaceutical industry.
The group aims to bring together experts and key actors to collaborate on initiatives to reduce the environmental footprint of pharmaceutical production.
Objectives include promoting the decarbonization of processes, preserving water and energy resources, sustainable waste management and encouraging circularity.

The working group’s ambition is to develop measurement and assessment tools specific to the pharmaceutical industry, to enable their environmental impact to be analyzed and understood. In addition, it will seek to develop a practical guide to help implement effective strategies for reducing ecological impact.
The aim of the CIG is to establish a fruitful collaboration between stakeholders, fostering innovation and the implementation of best practices to make the pharmaceutical industry more sustainable and environmentally friendly.
the CIG, which was launched on February 08, 2024.
It has 22 members and is currently organized into 4 sub-groups: Assessment, Water, Energy and Waste.

Members of the CIG
NameCompanyNameCompany
Christophe ASSIREQP PHARMANabila KHALOLAFRICPHAR
Vincent BALANDREAUFAREVA EXCELVISIONCéline MARCANDELLILFB
Nadia BALDOINFAMARMarina MARTIN CURRANHALEON
Fabrice BLOQUELASPENPaul Adrien MATHONAQE
Jean Pierre BOVEEAXYS-NETWORKYves MOINARDHUMANIM
Didier COLLAUDINLAB’CONSEILElia MOLINAROCHRISTEYNS
Laure DUCHATELLAPORTE SUISSEFabrice MORELFORTIL
Mickael FORMETVETOQUINOLYann NOIRJEANINCYTE BIOSCIENCES
Stephanie GAYOTEXPLEOMarie-Laure REMEZYEAU-DI-C
Guillaume GENTYSYNEXIN STERIGENESamah RINGAVEOLIA
Abdel KHADIREKOPEBernard RIOUXV3IE
A3P-Logo-CIG
Objectives

The objective of the A3P Lyophilization Working Group is to enable professionals to share best practices and address the concerns of the industry related to the lyophilization process: Annex 1, APS, contamination control, thermal mapping, silicone leaks, optimizing energy consumption, robotics and automation, risk analysis, CIP, SIP, thermal mapping, campaign mode, etc.

Members of the CIG
NameCompanyNameCompany
Sylvain BATIONBIOMERIEUXStéphane GORGERATFERRING
Vincent DAVIDLIVES INTERNATIONALBenoit MOREAUGSK
Elodie DECONINCKGSKPhilippe SELSISIMA
Laurent EUZETFAREVA PAUDominique SIERAKOWSKIDS ASEPTIC COMPLIANCE
Sandrine FAVREOCTAPHARMADenis TIXIERAMPHENOL SENSORS
Objectives & Achievement

The transport of pharmaceutical products has major challenges for pharmaceutical companies in terms of meeting their commitments on drug availability, financial issues (cost of destruction, handling of transport anomalies by quality assurance, control of logistics costs, efficiency of their internal processes, etc.) and also a risk in terms of the company’s public image; carriers, for their part, must demonstrate their reliability and rapid control of transport anomalies in order to win and secure their market share.
CIG A3P BPD proposes to tackle some of these issues and the practical means of resolving them through one or more working groups, by taking stock of applicable international regulatory requirements, procedures for alerting and controlling the risk of transport anomalies (temperature excursions, for example), and feedback from participating laboratories.
The main objective of CIG A3P BPD is to develop recommendations and improve Good Practices to optimize transport processes and compliance with regulatory requirements.

Members of the CIG
NameCompanyNameCompany
François ANDROP & GStéphanie HERBOMELSTALLERGENES GEER
Alassane BACHMPJean-Louis JOUVECOETIC
Jerome CRITTINFRESENIUS KABINicolas KAUFFMANSAPIOCHAIN
Alexandra GOUAZEPIERRE FABREGuillaume LE DOUXEUROFINS
Delphine HECHTEXPLEOMarion PEDOTAGUETTANT
Objectives & Achievements

The group works on the review of the ICH M4Q(R2) concept paper for the preparation of the public consultation scheduled for June 2024.
ICH M4Q guideline provides a harmonized structure and format for presenting Quality data in the CTD, registration file for pharmaceutical products (Module 2 Quality Overall Summary (QOS) and Module 3 Quality).
Revision 1 of this guideline (ICH M4Q(R1)) was created in 2002 and today requires changes to meet current challenges: the modernization and efficiency of these registration and life cycle management processes pharmaceutical products are major challenges in accelerating patient access to products and innovations.
May 2022: ICHQ12 conferences during the A3P Suisse Forum in Lausanne.
October 2021: Conference “Potentializing the QbD approach in the product life cycle: Regulatory Opportunities / ICH Q12” during the Process Control event in Lyon.
January 2020: Publication of articles in La Vague magazine:
ICH Q12: the basics. Review of the work of the A3P ICH Q12 GIC
Sept 2019: ICH Q12 Conference Day in Lyon. (PDF conference A3P member)
Nov 2018: Response to the public consultation on the ICH Q12 Guideline “Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management” at the EMA

Members of the CIG
NameCompanyNameCompany
Olivier ANTOINESANOFIStéphanie JABYLFB
Nadia BEAUDOUXLILLY FRANCERomain LE DEUNN/A
Frédérique CHAZOTPATHEON FRANCEAurélie MIEZE-RICHARDGUERBET
Katia CHOHBANEELSALYS BIOTECHJohanne PIRIOUAKTEHOM
Sylvie COTTAVOZINSTITUT DE RECHERCHE PIERRE FABREAnne RIGOULOTDELPHARM
Aminata DIAGNEINSTITUT PASTEUR DE DAKARSabine SARBACH DETOLLELABORATOIRES SERVIER
Objectives & Achievements

Continuing the CIG ROUGING, this CIG INOX aims to present to manufacturers a practical approach to ensure the management of stainless steel production equipment. This group, launched at the beginning of January 2024, is made up of 5 sub-groups:
Subgroup 1 – Stainless Steel: The theory
Subgroup 2 – The different stages allowing the proper management of stainless steel equipment (from 3a to 3e)
Subgroup 3 – The different steps for properly managing stainless steel equipment (from 3f to 3i)
Subgroup 4 – The different analytical methods and tests
Subgroup 5 – Contaminations encountered and associated treatments”

Members of the CIG
NameCompanyNameCompany
Frederic BERTHEUXMERCKFrederic GROULARDTECHNOCHIM
Laurence BRAZHALEONAbdel KHADIREKOPE
Coraline CLAEYSTECHNOCHIMElia MOLINAROCHRISTEYNS
Maxime CODEVELLETAKEDAGabriel SCHWARZBORER
Benjamin CONSTANTHUAYRUROJonnathan TAFFORINA3P
Florent DELERISSANOFIMarc VERNIERATECO TOBLER AG
Lionel DUBRAYGSK VACCINESDelphine VINCENTDIAGAST
Walid EL AZABQP PRO SERVICES
Objectives & Achievements

Following on from the GIC Remote Audit and the publication of the corresponding Guide, a new need was identified concerning Regulatory Inspections by health authorities and audits. A working group has been formed to address the Inspections & Audits lifecycle and their impact on the healthcare products industry. The main objective of the working group is to develop recommendations and improve Good Practices to optimize inspection and audit processes, whether scheduled or unannounced, and to move towards inspection readiness.

Due to the COVID-19 pandemic, remote audits and inspections have become more widespread. This new mode of evaluation presents advantages beyond health constraints, indicating that it will become more common and complementary to traditional practices. This evaluation format requires adopting new practices, which has raised numerous questions that the members of the working group (GIC) have attempted to address by creating a reference document for both auditors and auditees in the form of a Technical Guide:

Members of the CIG
NameCompanyNameCompanyNameCompany
Pierre ANDRELEO PHARMAAlain EUZENAXYS NETWORKMarie-Noel MAUMUSGMPC
Olivier ANTOINESANOFIMargot GIBERTCONSULTYSAnthony OLIVIERIPSEN
Nathalie BRICARDEXPLEO GROUPAnne HAYSA3PKarine PIERRELILLY
Hugues DESREUMAUXROCHESandrine KOLBRECIPHARMCécile POIROUXNOVO NORDISK
Alexandre DRAPIERGSKGael LE FILLIATREOCTAPHARMAAlban RHONEBIOELPIDA
Jean-Sébastien DUFRASNEMITHRA
Objectives & Achievement

Lifecycle management of analytical methods appeared in the Pharmacopeial Forum in 2013 (PF39(5)).
The USP proposed a USP 1220 draft chapter in 2020, which was the origin of the creation of this CIG.
The objectives of the CIG A3P Life Cycle of an analytical method are to present in 2024, in the form of 4 to 5 webinars, the main points of the guide published in June 2023 and the new ICH texts.
• webinar #1 – April 26, 2024: ICH Q2(R2) – Validation of analytical procedures
• webinar #2 – June 14, 2024: ICHQ14 – Analytical procedure development
• webinar #3 & #4 – 2nd semester: ICH Q2R2 / ICHQ14: valorization and sharing of knowledge, routine monitoring of methods.
The opportunity to collect your expectations for the 2nd version of the guide planned soon.
The GIC will also participate in the drafting of comments on new regulatory texts (for example USP chapter <1220> “Analytical Procedure Life Cycle”, which will follow the edition of the ICH guidelines).

The main area of ​​work concerns the management of the life cycle of analytical procedures, confirmed by the recent ICH Q2(R2) and Q14 guidelines, in order to replace the development/validation/transfer trilogy with a continuous approach, based on knowledge, mastery of established analytical technique, as well as risk analysis, to control critical product attributes.

June 2023: Publication of a guide based on the tools proposed by USP1220 and was published before the final version of the ICH texts (ICHQ14 and ICHQ2(R2)).
March 2022: Comments on the ICH texts (ICHQ14 and ICHQ2(R2)) step 2
November 2021: Comments on USP chapter <1220> “Analytical Procedure Life Cycle”

Members of the CIG
NameCompanyNameCompanyNameCompany
Pascale AUTHOUARTORIL INDUSTRIEJean-François DIERICKGSK VACCINESIsabelle MOINEAUAKTEHOM
Jean-François BOECATALENTMarc FRANCOIS-HEUDESANOFIJean-Marc ROUSSELJM ROUSSEL
Eric CHAPUZETQUALILABMuriel LONDICHEBAYERDominique SOTTYTECHNOLOGIE SERVIER
Philippe CIRERAAR2ICyril MEUNIERNUVISANMyriam ZEBINASTALLERGENES GREER
Gérald DE FONTENAYCEBIPHAR
Objectives & Achievements

CIG Microbiologie – Alternatives Methods version 1, whose aim was to take stock of the use of so-called “modern” alternative microbiological methods, was created in 2019.
This work led to a survey of the current situation of AMMs in our industries, presented at the 2022 Microbiology Meetings (link to event presentation).
In parallel with these collective reflections, we have also been able to identify a number of subjects relating to the day-to-day running of microbiology laboratories which raise questions or justify the pooling of experience to enable the various players to respond to changing needs (bacterial identification strategy, good practices, applicability of alternative methods, etc.).
In the light of these factors, we propose to launch a new version of the “Microbiology Laboratory” CIG, to address all the work involved in the day-to-day running of microbiology laboratories.
This working group will bring together all those involved in industrial microbiology, in order to continue the work and draw up a practical guide. The call for new members closes on 03/11/2024.

Members of the CIG
NameCompanyNameCompanyNameCompany
Alexis BILLARDBRACCO Guillaume GUIBERTGUERBETFélix MONTERO JULIANBIOMERIEUX
Hélène BLONDELSANOFIKurt JAECQUESGSK VACCINESThierry MULLERMERCK
Thierry BONNEVAYSANOFI PASTEURLaurent LEBLANCBIOMERIEUXEric PETATACM PHARMA
Arnaud CARLOTTIEUROFINS IDMYKValérie LE JUEZIPSENIlaria SCARFONETHERMO FISHER
Séverine GAUBERTSARTORIUSMarine MARIUSSANOFIPhilippe TAILLIEZACM PHARMA
Objectives & Achievements

After publication of the guide in 2022, the group will continue its work and has identified 3 themes for 2024 :
1. Control Strategy (implementation and follow-up) & Sampling Plan (strategy/justification)
2. Critical Material Attributes (CMA): How to manage them?
3. The level of detail in the regulatory file & QbD
An event is also being prepared for 2025 on Product life cycle

2023: Article La Vague n°78 “”How to build a risk-adapted sampling strategy“” + presentations at the Biarritz International Congress : 2 conferences + 2 workshops
February 2022: Technical & Scientific Guide “QbD: an approach aimed at gaining a better understanding of the process, so as to better manage it rather than suffer from it (Stages 1 & 2)”

Members of the CIG
NameCompanyNameCompany
Nathalie BRICARDEXPLEOViviane NERON DE SURGYVETOQUINOL
Aude COLINDEBIOPHARM INTERNATIONALLaure PLANCHEFAB ENTECH
Nathalie DALLYABBVIEMorgane SPAGNOLAKTEHOM
Eric DREVETONBOEHRINGER INGELHEIMDamien STEFANELLIMEDINCELL
Sandrine DUCLOSVIRBACChung TRINHPATHEON THERMOFISHER
Elodie KEROMNESVIRBACStephane VARLETPROCTER & GAMBLE
Stephan KOPYLAVIRBAC
Christelle LOURDSANOFI
Objectives & Achievements

Draw up recommendation guides for manufacturers: deployment, use and maintenance (Life Cycle Management) of Single-Use System (SUS) solutions. Provide an overview of key SUS issues: validation, environmental impact, integrity testing, extractables/relarguables, etc. Facilitate exchanges and information sharing between users and suppliers, in order to anticipate developments and work jointly on shared standards. Promote technical solutions using closed systems and containment systems for toxic products.

In 2024, 5 sub-working groups will be responsible for the following topics, among others:

– Updating A3P SUS guides – state of the art, Technical Report creation

– SUS standardization (multi-component & like for like & “how to make the SU less operator and supplier dependent”)

– Technology watch / help in defining needs & expectations (probe, sampling)

– SUS-related contamination (nitrosamines / Reach / PFAS: ICHQ3D and Q3C / RNase): state of the art and recommendations

– Comparative XRay / Gamma / Electron Beam irradiation (ebeam) (impact, efficiency, sourcing, …)

Members of the CIG
NameCompanyNameCompanyNameCompany
Muzeyyen AYDOGMUSABL EuropeGuillaume DUPONTASPENCamille PERQUINLAPORTE EURO
Jean-Louis BELMONVIRBACCédric HAEMERSUCBPriscille PINGAULTAKTEHOM
Pierre-Michel BODSONUNIVERCELLS TECHValérie KANDELLILLY FRANCEPascal REBOULETRAUMEDIC
Marie-Agnès BOLLFB BIOMEDICAMENTSAurélie LABOURIERRECIPHARMLaurent RODRIGUEZST GOBAIN
Mehdi BOUKAMIMERCKDelphine LALLEMENTCYTIVAMarine ROUSSETTECHNIPFMC FRANCE
Fabien DEBRASZOETISCharlotte MASYGSK VACCINESJérôme TORRESASEPTIC GROUP
Brigitte DELAPLACEPHARMASEPKatell MIGNOTSARTORIUS STEDIM FMTPhilippe WAGHEMACKERSANOFI
Aurélie Camille DESROUSSEAUXFORTILJean-Philippe MINNEPARKER HANNIFIN FRANCE
Eric DEVRETONBOEHRINGER INGELHEIMWouter PALMAERTSTHERMO FISHER SCIENTIFIC
Objectives & Achievements

The group provided comments on the Guideline “Guidance on ‘Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development’ (EMA/CHMP/138502/2017).” The group participated in the EMA workshop in May 2018 on the “Guidance on ‘Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development’ (EMA/CHMP/138502/2017).”

Members of the CIG
NameCompanyNameCompanyNameCompany
Meriem ABDENNOURSANOFI PASTEURMourad MELLALCATALENTAnne RIGOULOTDELPHARM
Sébastien LE GUILLOUSOLADISMarinette MOREAUCEVA SANTE ANIMALECatherine TUDALSOLADIS
Caroline LEVEDERSANOFI
A3P-Logo-CIG
Objectives & Achievements

The work of this GIC is completed.

Members of the CIG
NameCompanyNameCompany
Peggy AUNEYBECTON DICKINSON MEDICAL PHARMACEUTICAL SYSTEMSJulie RACAUDAGUETTANT
Jacqueline BESSETASSYSTEMS CAREJean-Luc REGAUDIESANOFI
Dominique DISSLILLY FRANCEJonnathan TAFFORINA3P
Walid EL AZABSTERISJulien TRIQUETGSK
Philippe LE GALLAPATAR STELMIDominique WEILLDOWELI
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Objectives & Achievements

Particulate Risk Management in Injectable Products

The Particles GIC is the first one created within A3P. It served as a model, and the statutes were drafted to function as other GICs, with the collaboration of experts and the possibility to create sub-working groups. The GIC delivered various outputs, including recommendations, technical documents, and monographs.

The Particles GIC was established in 2013 and was led by Alain EUZEN until 2017. Throughout its existence, the GIC obtained the real collaboration of over 70 experts, whom we sincerely thank for their contributions. They were willing to share their practices, engage in technical discussions, and review and work on tests related to standardization. It was a substantial and beneficial effort for the entire A3P community and beyond. Participants from different European countries (France, Belgium, Switzerland, Germany) showed great commitment.

Given the magnitude of the task and numerous requests following regulatory inspections, the GIC structured itself into four sub-working groups:

  • Sub-Group 1: Primary packaging and transportation, distinguishing between glass articles, elastomers, and disposables or single-use systems (led by François FONVIELLE – Sanofi Pasteur and Benoît LUX – Lilly France).
  • Sub-Group 2: Manufacturing and distribution (led by Alain EUZEN – Sanofi Pasteur).
  • Sub-Group 3: Visual inspection (Romain VEILLON – GSK Vaccines).
  • Sub-Group 4: Complaints, market recalls, and overall statistical data (Patrick TURLIER – GSK).

Thus, the GIC developed a comprehensive understanding of the particulate issue in injectable products.

Knowledge and progress sharing by the GIC took place during four Particles Forums in Le Vaudreuil (Eure) and Lyon between 2013 and 2016, as well as through numerous publications in La Vague and conference presentations (Biarritz Congress, Pharmaceutical Industry Days in Lille, SFSTP seminar in Paris).

A3P-Logo-CIG
Objectives

Providing the tools to implement visual inspection processes in the middle of the injectables production chain. A new guideline will present the work of the CIG such as: the qualification of operators for manual visual inspection, the management of a new or the disappearance of an old defect, the matrix approache throughout the qualification of an automatic machine, and the management of a batch potentially heterogeneous. The CIG is also working on organizing an event on visual inspection during which some of the topics in the guide, and many others, will be presented.
November 19-20, 2024: visual inspection event in Lyon
Sept. 2024: publication of new guideline
Oct. 2022: Publication of A3P Guideline : Good practices for the implementation of an automatic visual inspection process for injectable products
Oct. 2022: A3P Annual Congress (PDF conferences workshops A3P member area)

Members of the CIG
NameCompanyNameCompanyNameCompany
Delphine AMOURETASPEN NDBAlban LANGLOISASPEN NDBJonnathan TAFFORINA3P
Cécile CHOPINETSANOFISteven MAZOUINNOVONORDISKJean-Michel TASSERITAVI CONSULTING
Sabrina DI VICOLEO PHARMAValérie RAUTUREAULILLYElise TOURLETUCB
Gregory DUVALTEOXANEDjonny RIGOTSANOFIJeremy UDENOVONORDISK
Aurélien GENETGSKChiara SINITOWILCO
Objectives & Achievements

This group works on the subject of water for pharmaceutical use in order to allow the various manufacturers concerned to discuss these questions, and to reach common consensus in order to facilitate the implementation of the EMA Guideline entitled: “Guideline on the quality of water for pharmaceutical use”.

  • January 2024: the group continues its work on the theme of controlling contamination of water loops
  • November 2023: publication of the Water Guide bringing together all applicable regulations and management of production facilities (design, production and monitoring).
  • December 2020: Conducted two webinars on the latest regulatory developments, their impacts on the design and maintenance of production and distribution systems, as well as the latest trends in monitoring (PDF materials available in the A3P member area)
  • May 2019: Response to the public consultation on the draft issued by the EMA titled “Guideline on the quality of water for pharmaceutical use”
Members of the CIG
NameCompanyNameCompanyNameCompany
Virgile CADORELSANOFIOlivier LAMBERTSANOFIMarie-Laure REMEZYEAU-DI-C
Christian COLLETBECKMAN COULTERGuillaume LEDOUXEUROFINS PHARMA QUALITY CONTROLSamah RINGAVEOLIA
Pierre CULLMANNBWT FRANCEMickael MALLENSANOFIKonrad SAEGESSERSWAN ANALYTICAL
Michael DE HOVREGSK VACCINESFrédéric MONNIERVEOLIA WATER STI
Guy KASDEPKALABORATOIRES PHARMASTERAurélien PERIQUETMERCK