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 & 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 WGI
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Antoine AKAR | HUMANIM | Sandrine FAVRE | OCTAPHARMA | Sophiane NAILI | IPSEN |
Marc BESSON | AXYS NETWORK | François GUILLOU | DELPHARM | Nicolas RESTENCOURT | SANOFI |
Nicolas BOURGEOIS | SANOFI | John HARGREAVES | JHCONSULTANTS | Emna SLAMA | SYNEXIN |
Lydia BRETEAU | LABORATOIRES BOIRON | Isabelle HOENEN | LILLY | Jonnathan TAFFORIN | A3P ASSOCIATION |
Pierre DEVAUX | THERAXEL | Eric HURTUBISE | VALIDAPRO | Julien TRIQUET | CSL BEHRING |
Jean-François DULIERE | ISPE | Guy KASDEPKA | PHARMASTER | Joelle VAN DE KERKHOVE | ZOETIS |
Walid EL AZAB | STERIS | Virginie MARTINON | BOEHRINGER INGELHEIM | Dominique WEILL | DOWELI |
Objectives & Achievements
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:
- May 2023: A3P Technical Guide “Remote Audit: Recommendations”
The group has set a new objective to work on the publication of a manual on “Preparation Practices for Audits and Inspections.” This manual would not only describe generic best practices but also highlight specific areas of focus and provide tips, such as in the field of sterile manufacturing and the new Annex 1. (Publication coming soon)
Members of the WGI
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Pierre ANDRE | LEO PHARMA | Jean-Sébastien DUFRASNE | MITHRA | Gael LE FILLIATRE | OCTAPHARMA |
Olivier ANTOINE | SANOFI | Alain EUZEN | AXYS NETWORK | Marie-Noel MAUMUS | GMPC |
Nathalie BRICARD | EXPLEO GROUP | Margot GIBERT | AMARIS | Karine PIERRE | LILLY |
Hugues DESREUMAUX | ROCHE | Anne HAYS | A3P | Cécile POIROUX | NOVONORDISK |
Alexandre DRAPIER | GSK | Sandrine KOLB | RECIPHARM | Alban RHONE | BIOELPIDA |
Objectives & Achievements
The complexity and diversity of aseptic processes require tailored Barrier Technology solutions for each of them. The development of new therapeutic alternatives, especially in the field of Advanced Therapy Medicinal Products, necessitates the search for solutions for predominantly manual processes that require high dexterity. The work and sharing of best practices by the members of the Working Group are intended for professionals to optimize their production processes, including validation standards, maintenance standards, and operational standards related to the use of barrier technologies, incorporating international recommendations (Annex 1, ISPE 2005, PHSS 2010), and identifying different “Barrier Technology” solutions.
- Sept 2021: Technical Days (conferences) in Tours.
- Oct 2020: Publication of an article in La Vague: “There is everything to gain from working in campaign mode, a breakthrough in isolator productivity.“
- Nov 2019: Creation of a practical training module: “Visual Inspection of Gloves and Sleeves under Isolators.”
- March 2019: Technical Days (conferences) in Pau.
- March 2017: Technical Days (conferences) in Pau.
- January 2017: Publication of an article in La Vague: “Secure the containment of your gloves“
- March 2015: Technical Days (conferences) in Pau.
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Franck ARETHUSE | PIERCAN | Laurent FLUHR | SKAN | Guillaume MOLLANDIN | LONZA |
Marc BESSON | AXYS-NETWORK | Eric GOHIER | JCE BIOTECHNOLOGY | Cyril MOUNIER | GETINGE – LA CALHENE |
Pascal CHAMPAGNAT | BOEHRINGER INGELHEIM | Gregory GUILLAUME | NA | Florelle TOURLET | OCTAPHARMA |
Patrick COPPENS | ISOTECXEL | Etienne HEMBERT | LILLY FRANCE | Antoine TOUSSAINT | GSK VACCINES |
Alain DESERT | EREA | Didier MEYER | DMCOMPLIANCE | Julien TRIQUET | CSL BEHRING |
Edith FILAIRE | GROUPE ICARE |
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.
Members of the WGI
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Mohamed Ali AKKARI | UNIMED | Mélissa CHEVALIER | ASPEN NDB | Mohamed HABAZ | ATRYON |
Christophe BENOIT | ROMMELAG | Rodolphe CHOVY | THERAXEL | Michel LE CADRE | UNITHER |
Delphine BOIVIN | FAREVA EXCELVISION | Lauriane FREYCHET | FAREVA EXCELVISION | Pascal LUDAESCHER | RECIPHARM KAYSERSBERG |
Alexandra BRIAUX | BOIRON | Patrick GERVAIS | GILBERT | Claire PASTORE | AGUETTANT |
François CABOULET | ASPEN NDB |
Objectives & Achievement
One of the objectives of the Working Group will be to propose a decision tree (methodology, rationale) to support all high-value projects by listing key steps, prerequisites, and points of vigilance throughout the development of a Biopharmaceutical product.
Prerequisites and points of vigilance (non-exhaustive list):
- Process reproducibility
- Characterization of standards
- Level of qualification of analytical methods
- Analytical process validation
- Stability testing program
- Identification of raw materials/suppliers
- Regulatory strategy
- Quality documentation
- …
Members of the WGI
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
ANQUETIN Maxime | AIR LIQUIDE | GILON Nicolas | CATALENT | RIGOULOT Anne | DELPHARM |
BAZOT Quentin | ABL EUROPE | HUBERT Dorothée | AVANTOR VWR | RIOU Edwige | AKTEHOM |
BELMON Jean-Louis | VIRBAC | JUST Olivier | GENOSAFE | SANDER Peggy | ILS |
BORTOLIN Elena | FAB’ENTECH | LEROY Celine | NAOBIOS | SLAMA Emna | SYNEXIN |
CASSART Anne | LSB | MARZOUKI Farah | PK MED | SOBCZYK André | CHUV |
CECILLE Marie | MERCK CTDMO | MICHEL Sophie | SMICHEL Consulting | VAN VYNCHT Géry | QUALITY ASSISTANCE |
DESNOYER Margaux | ALTEREGO BIOTECH | MONTEMONT Lionel | POLYPLUS | VERHOEYE Francis | EXOTHERA |
DUBOIS Luc | VALIDAPRO | NERRIERE Olivier | LAPORTE EURO | ZIEGLER Thierry | HUMANIM |
DURACHER David | AMOLYT | PARIS Jérémy | SON | ||
EL GUEDDARI Morad | YPOSKESI | RACHON Alain | CORE BIOGENESIS |
Objectives & Achievements
Following the revision of Annex 15 published in 2015, A3P decided to create a Cleaning Validation Working Group to support industry professionals in understanding the expectations of Health Authorities and the aforementioned annex. The purpose of this working group was to address all major topics related to cleaning validation, including the selection of worst-case products, determination of acceptance criteria (with a significant focus on PDEs newly requested by Annex 15), equipment train, applicable sampling methods, personnel training, types of cleaning and levels of automation, and other parameters to consider in the cleaning validation exercise such as DHT, CHT, and batch sizes.
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.
- 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:
- The A3P Cleaning Validation Working Group is preparing a practical guide for autumn 2017 on Chapter 10 of Annex 15 of the European GMP: Presentation & Discussion
- Biocidal regulations applied to the disinfectants used in the pharmaceutical industry: all you need to know…
- Cleaning control strategy in the production of active pharmaceutical ingredients for clinical use Indirect visual inspection modernizes cleaning validation
- Recovery rate determination as a preliminary step required in a cleaning validation exercise
- Implementation of the “health-based approach” for setting limits in cleaning validation for Vaccines/Biotech
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
BONNEAU Guillaume | NOVO NORDISK | Agnès FRANCO | VIRBAC | Laurent SIMON | COPHACLEAN |
Sophie BOURGOIS | ASPEN NDB | Guillaume GARREAU | HALEON | Denis STREITT | ECOLAB |
Emmanuel BLANC | NOVO NORDISK | Solenn JANVIER | PIERRE FABRE | Philippe TAILLIEZ | ACM PHARMA |
Pierre DEVAUX | THERAXEL | Elsa LAJUS | FAREVA PAU | Marie-Bénédicte TESSIER | VETOQUINOL |
Soline DION | CEHTRA | Nassim OUALI | CENEXI FONTENAY | Audrey THIERY | DELPHARM |
Marion DUMONT | CHRISTEYNS | Nicolas PALLUET | CONTEC EUROPE | David UGOLINI | DELPHARM |
Stéphane DURAND | CONFORMAT | Julie RACAUD | LABORATOIRE AGUETTANT | Audrey THIERY | UPS CONSULTANTS |
Audrey FOURCADE LABEILLE | LFB | Thomas ROHAUT | AKTEHOM | Laurianne ZUCHUAT | VIFOR |
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).
- Nov. 2021: Publication of the A3P CPV Guideline Operational guidance Continued Process Verification (CPV)
- June 2021: A3P Process Control Conference (PDF conferences available on the A3P member area)
- July 2019: Articles published in La Vague magazine:
Members of the GIC
Name | Company | Name | Company |
---|---|---|---|
Damien BONNET | PATHEON THERMOFISHER | Audrey IMBERT-CLIGNAC | VETOQUINOL |
Véronique BRIANTO-GABIER | MAAT PHARMA | Mohamed KADEM | SKYEPHARMA |
Stéphane COULEE | FAREVA PAU | Alain NONN | ALPHA PHARMA CONSULTING |
Sabrina GALLAY | ASPEN NDB | Sophie METTEIL | IPSEN |
Valerie HERON | SANOFI | Murielle PERNEL | LILLY FRANCE |
Michel HERTSCHUH | AKTEHOM |
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. They participate in regulatory text comments (e.g., Annex 11) and share best practices (CSV, etc.).
- 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
- 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 GIC
Name | Company | Name | Company |
---|---|---|---|
Aymeric BEAUSSANT | UCB FARCHIM | Jean-Louis JOUVE | COETIC |
Estelle BOROWIEC | LILLY | Cedric MAUNOURRI | ORAVIS |
Hugo BOUQUET | BIOMERIEUX | Pascale MOSNIER | LABORATOIRES SERVIER |
Laurent CLAUSS | CEVA | Lionel PELLETIER | AKTEHOM |
Hervé CLUZEAUD | ASSYSTEM EXPLEO GROUP | Thierry PETRUCCI | CVO EUROPE |
Jean-Sebastien DUFRASNE | MITHRA | Elodie RAGNE | GETINGE |
Aurélien DUJARDIN | ASPEN NDB | Pierre-François SAMBRONI | CYRNOS CONSEIL |
Loic GUYON | NEMERA |
Objectives & Achievements
The work of this Working Group has been completed.
- November 2017: Publication of an A3P Scientific and Technical Guide: “Control of supplier risks and cross contamination Survey and summary of regulatory changes EU-GMP Part.1 Chap. 3 and 5“
- October 2016: Response to the public consultation on “Guidance on the sterilisation of the medicinal product, active substance, excipient and primary container: EMA/CHMP/CVMP/QWP/BWP/850374/2015”
Members of the GIC
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 & Achievements
- January 2020: Publication of articles in La Vague magazine:
- 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 GIC
Name | Company | Name | Company |
---|---|---|---|
Olivier ANTOINE | SANOFI | Romain LE DEUN | MODERNA |
Nadia BEAUDOUX | LILLY FRANCE | Aurélie MIEZE-RICHARD | GUERBET |
Frédérique CHAZOT | PATHEON FRANCE | Johanne PIRIOU | AKTEHOM |
Sylvie COTTAVOZ | INSTITUT DE RECHERCHE PIERRE FABRE | Anne RIGOULOT | DELPHARM |
Aminata DIAGNE | INSTITUT PASTEUR DE DAKAR | Sabine SARBACH DETOLLE | LABORATOIRES SERVIER |
Stéphanie JABY | LFB |
Objectives & Achievement
The management of the lifecycle of analytical methods emerged in the Pharmacopeia Forum in 2013 (PF39(5)) and has received several stimuli related to the concepts of ATP (Analytical Target Profile), method performance (measurement uncertainty, Chapter <1210> of the USP), and control strategy.
The objective is to replace the traditional trilogy of method development/validation/transfer with a continuous approach that allows for iterative steps based on the knowledge and control of the analytical technique implemented to monitor critical attributes of products.
The objectives of the A3P Analytical Method Lifecycle Working Group are:
- Contribute to the drafting of comments, for example, on the revision of the USP Chapter <1220> “Analytical Procedure Life Cycle.”
- Define a practical guide for industry professionals that will help them understand the expectations of this phenomenon and manage it in the long term.
- Continue the work based on future ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) texts (ICHQ14 and ICHQ2(R2)).
Members of the WGI
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Pascale AUTHOUART | ORIL INDUSTRIE | Philippe CIRERA | INNATE PHARMA | Isabelle MOINEAU | AKTEHOM |
Alexandra BELVEZE | EUROFINS AMATSI ANALYTICS | Gérald DE FONTENAY | CEBIPHAR | Soraya SLIMANI | STALLERGENES GREER |
Jean-François BOE | CATALENT | Jean-François DIERICK | GSK VACCINES | Dominique SOTTY | TECHNOLOGIE SERVIER |
Bruno BOULANGER | PHARMALEX BELGIUM | Marc FRANCOIS-HEUDE | SANOFI | ||
Eric CHAPUZET | QUALILAB | Cyril MEUNIER | NUVISAN |
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.
- April 2023: A3P Lyophilization Conference Days (PDF conferences available in the A3P member area).
- April 2022: Release of the infographic “Keys to Successful Qualification and Energy Exchange.“
- March 2021: Publication of the A3P Lyophilization Guide: Temperature mapping: a checklist for successful qualification
- July 2019: A3P Lyophilization Conference Days (PDF conferences available in the A3P member area).
- October 2017: A3P Lyophilization Conference Days (PDF conferences available in the A3P member area).
- June 2015: A3P Lyophilization Conference Days (PDF conferences available in the A3P member area).
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Sylvain BATION | BIOMERIEUX | Sandrine FAVRE | OCTAPHARMA | Philippe SELSIS | IMA |
Vincent DAVID | LIVES INTERNATIONAL | Stéphane GORGERAT | FERRING | Dominique SIERAKOWSKI | DS ASEPTIC COMPLIANCE |
Elodie DECONINCK | GSK | Benoit MOREAU | GSK | Denis TIXIER | AMPHENOL SENSORS |
Laurent EUZET | FAREVA PAU | Charles NODOT | ELLAB |
Objectives & Achievements
This group first allows for an assessment of the methods proposed, considered, evaluated, adopted, and rejected by all pharmaceutical industry laboratories, along with their proven advantages and disadvantages. This group is currently working on the creation of a validation guide.
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Alexis BILLARD | STALLERGENES | Guillaume GUIBERT | GUERBET | Félix MONTERO JULIAN | BIOMERIEUX |
Hélène BLONDEL | SANOFI | Kurt JAECQUES | GSK VACCINES | Thierry MULLER | MERCK |
Thierry BONNEVAY | SANOFI | Laurent LEBLANC | BIOMERIEUX | Eric PETAT | TERANGA |
Arnaud CARLOTTI | EUROFINS IDMYK | Valérie LE JUEZ | IPSEN PHARMA BIOTECH | Ilaria SCARFONE | THERMO FISHER SCIENTIFIC |
Séverine GAUBERT | SARTORIUS | Marine MARIUS | SANOFI | Philippe TAILLIEZ | ACM PHARMA |
Objectives & Achievements
This group aims to create a practical and technical guide to demystify the concepts presented in regulations, such as establishing the QTPP (Quality Target Product Profile), defining critical process parameters and critical quality attributes of the product, and the design space, in order to develop and validate a robust and capable process with an effective and appropriate control strategy. This GIC will complement the “CPV Continued Process Verification” and “statistical methodology for the comparative assessment of quality attributes in development” GICs.
- February 2022: Technical and Scientific Guide “QbD: An approach to better understand the process, to better control it rather than being subject to it (Stages 1 & 2).“
Members of the GIC
Name | Company | Name | Company |
---|---|---|---|
Isabelle BONNAVENTURE | SKYEPHARMA | Christelle LOURD | SANOFI |
Nathalie BRICARD | EXPLEO | Viviane NERON DE SURGY | VETOQUINOL |
Aude COLIN | DEBIOPHARM INTERNATIONAL | Laure PLANCHE | FAB ENTECH |
Nathalie DALLY | ABBVIE | Morgane SPAGNOL | AKTEHOM |
Eric DREVETON | BOEHRINGER INGELHEIM | Damien STEFANELLI | MEDINCELL |
Sandrine DUCLOS | VIRBAC | Chung TRINH | PATHEON THERMOFISHER |
Elodie KEROMNES | STALLERGENES | Stephane VARLET | PROCTER & GAMBLE |
Stephan KOPYLA | VIRBAC | Benjamin VITRAT | FERRING INTERNATIONAL |
Romain LE DEUN | MODERNA |
Objectives & Achievements
The main objectives of the A3P Rouging / Dérouging working Group (GIC) are:
- Define a practical guide for industrial professionals that will help them understand and manage this phenomenon in the long term.
- Presentations during a themed day and other A3P events.
- Provide a space for technological watch and innovation through scientific articles and synthesis files for members, via certain existing media.
- May 2023: A3P Rouging & Dérouging Webinar (PDF conferences A3P member area)
- Sept 2022:
- A3P Rouging & Dérouging Conference Day (PDF conferences A3P member area)
- Publication of the Practical guide on Rouging / Derouging management
- Sept 2019: A3P Rouging & Dérouging Conference Day (PDF conferences A3P member area)
Members of the GIC
Name | Company | Name | Company |
---|---|---|---|
Laurence BRAZ | HALEON | Elia MOLINARO | CHRISTEYNS |
Coraline CLAEYS | TECHNOCHIM | Jonnathan TAFFORIN | A3P |
Lionel DUBRAY | GSK VACCINES | Marc VERNIER | ATECO TOBLER AG |
Walid EL AZAB | STERIS | Delphine VINCENT | DIAGAST |
Abdel KHADIR | EKOPE |
Objectives & Achievements
Establishing recommendation guides for industry professionals: deployment, use, and maintenance (Life Cycle Management) of Single-Use solutions. Conducting an overview of key issues related to Single-Use Systems (SUS): validation, environmental impact, integrity testing, extractables/leachables, etc. Facilitating information exchange and sharing between users and suppliers to anticipate developments and collaborate on shared standards. Promoting technical solutions using closed systems and containment systems for toxic products.
- Oct 2021: A3P Annual Congress (PDF conferences A3P member area)
- December 2020:
- March 2019: Technicals Day Conferences in Italy (PDF conferences A3P member area)
- October 2018: Technicals Day Conferences in Lyon (PDF conferences A3P member area)
- July 2018: Articles published in the magazine La Vague:
- Continuous Processing. Performance Enhancements for Perfusion Applications in 50L to 500L Single-Use Bioreactors: A Technical Comparison of Performance Characterization, Cell Culture & Scale-Up Modeling
- Single use connection technologies: current situation and trends
- Extractables and Leachables from SUS – aspects beyond Extractables Measurement & standardization
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Sébastien BARRY | SANOFI | Jean-Yves DUVAL | SANOFI | Priscille PINGAULT | AKTEHOM |
Jean-Louis BELMON | VIRBAC | Valérie KANDEL | LILLY FRANCE | Laurent RODRIGUEZ | ST GOBAIN |
Pierre-Michel BODSON | UNIVERCELLS TECH | Aurélie LABOURIER | RECIPHARM | Marine ROUSSET | TECHNIP FMC |
Marie-Agnès BOL | LFB BIOMEDICAMENTS | Charlotte MASY | GSK VACCINES | Jérôme TORRES | ASEPTIC PROCESS EQUIPMENT |
Mehdi BOUKAMI | MERCK | Katell MIGNOT | SARTORIUS STEDIM FMT | Philippe WAGHEMACKER | SANOFI |
Brigitte DELAPLACE | PHARMASEP | Jean-Philippe MINNE | PARKER HANNIFIN | ||
Aurélie DOWNES | ASPEN NDB | Wouter PALMAERTS | THERMO FISHER SCIENTIFIC | ||
Eric DEVRETON | BOEHRINGER INGELHEIM | Camille PERQUIN | LAPORTE EURO |
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).”
- July 2019: Articles published in the magazine La Vague:
- 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).”
Members of the GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Meriem ABDENNOUR | SANOFI | Mourad MELLAL | GSK VACCINES | Anne RIGOULOT | DELPHARM |
Sébastien LE GUILLOU | ASPEN | Marinette MOREAU | VETOQUINOL | Catherine TUDAL | SOLADIS |
Caroline LEVEDER | SANOFI | Alice RAILLARD | SANOFI |
Objectives & Achievements
The work of this GIC is completed.
- Jan. 2020: Publication of an article in the magazine “La Vague”: New EMA Sterilization guideline Guideline on the sterilisation of the medical product, active substance, excipient and primary container (EMA/CHMP/CVMP/QWP/850374/2015)
- Oct. 2018: Response to the public consultation on the “Guideline on the sterilization of the medicinal product, active substance, excipient, and primary container.”
- March 2017: Technical Day Conferences (PDF conferences A3P member area)
Members of the GIC
Name | Company | Name | Company |
---|---|---|---|
Peggy AUNEY | BECTON DICKINSON | Julie RACAUD | AGUETTANT |
Jacqueline BESSET | ASSYSTEM CARE | Jean Luc REGAUDIE | SANOFI R&D |
Dominique DISS | LILLY | Jonnathan TAFFORIN | A3P |
Walid EL AZAB | STERIS | Julien TRIQUET | CSL BEHRING |
Philippe LE GALL | APTAR STELMI | Dominique WEILL | DOWELI |
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).
Objectives
In a context of increasing regulatory requirements for defect detection, providing producers with the tools to enhance the value of visual inspection processes in the middle of the injectables production chain.
- 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 GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Delphine AMOURET | ASPEN | Aurélien GENET | GSK | Chiara SINITO | WILCO |
Cécile CHOPINET | SANOFI | Alban LANGLOIS | ASPEN NDB | Jonnathan TAFFORIN | A3P ASSOCIATION |
Sabrina DI VICO | LEO PHARMA | Steven MAZOUIN | NOVONORDISK | Jean-Michel TASSERIT | AVI CONSULTING |
Gregory DUVAL | TEOXANE | Valérie RAUTUREAU | LILLY | Elise TOURLET | CATALENT |
Brahim ELHOSAYNY | CENEXI | Djonny RIGOT | SYNTEGON | Jeremy UDE | LEO PHARMA |
Objectives & Achievements
This group works on the topic of pharmaceutical water in order to facilitate exchanges among the various concerned industrial stakeholders and reach common consensus to facilitate the implementation of this guideline.
- 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 GIC
Name | Company | Name | Company | Name | Company |
---|---|---|---|---|---|
Virgile CADOREL | SANOFI | Olivier LAMBERT | SANOFI | Aurélien PERIQUET | OCTAPHARMA |
Christian COLLET | BECKMAN COULTER | Guillaume LEDOUX | EUROFINS PHARMA QUALITY CONTROL | Marie-Laure REMEZY | EAU-DI-C |
Pierre CULLMANN | BWT FRANCE | Mickael MALLEN | SANOFI | Samah RINGA | VEOLIA |
Michael DE HOVRE | GSK VACCINES | Frédéric MONNIER | VEOLIA WATER STI | Konrad SAEGESSER | SWAN ANALYTICAL |
Guy KASDEPKA | LABORATOIRES PHARMASTER |