Annex1 GMP EU - V12 . 2020

Revision: Manufacture of Sterile Medicinal Products

Time

5pm to 7pm

Date

December 2020

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Format

Webinar

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Substantial changes were introduced in several sections of this new version 12 of Annex 1 published on February 20th,  2020 (Annex1 GMP Eu v12 .pdf).

The EMA has engaged several associations, and in particular A3P, to support this new stage of consultation which aims to gather the experience of manufacturers.

The A3P Annex 1 WGI, composed of experienced industrials, worked for several months on all the chapters open for comment in version 12. With over 120 proposals, the work of WGI A3P Annex 1 covers the entire text and reflects the point of view of manufacturers who want to guarantee patients an optimal level of quality in the production of sterile medicines.

The final version of these comments was sent to the EMA on 16 July 2020.
A3P is holding webinars led by its experts to present its comments, explain the process, the objective and the analysis of the associated risks.

INFORMATION
  • Each webinar is accessible independently
  • Compulsory registration
  • Time slot : 5pm to 7pm (presentation + Q&A)
Webinars A3P : Annex1 GMP EU - V12 2020
Revision: Manufacture of Sterile Medicinal Products (Draft)
#1 Revision of GmP EU Annex1 V12 2020 : Overview
Speakers - Julien Triquet (GSK) & Sandrine Favre (OCTAPHARMA)
Nicolas Bourgeois (GSK VACCINES) & Pierre Devaux (THERAXEL)
Global review of the work of the A3P Annex1 working group: Review process and consolidation of comments before sending to the EMA. Main changes compared to the current 2008 version. Key comments made by WGI A3P Annex 1 (cover letter).
03 Dec. 2020
05pm to 07pm
#2 Contamination Control Strategy (CCS)
Speakers - Nicolas Bourgeois (GSK VACCINES) & Pierre Devaux (THERAXEL)
Sandrine Favre (OCTAPHARMA) & Julien Triquet (GSK)
  • Review of a major new element of Annex 1 "Contamination Control Strategy": principles and requirements
  • Other significant comments of Annex 1 related to CCS (critical process times, decontamination process...)
10 Dec. 2020
05pm to 07pm
Webinars A3P : Annexe 1 GMP EU - V12 2020
Revision: Manufacture of Sterile Medicinal Products (Draft)
#1 Revision of GmP EU Annex1 V12 2020
-> Support de présentation disponible dans l'espace adhérent A3P
Animateurs - Nicolas Bourgeois (GSK VACCINES) & Sandrine Favre (OCTAPHARMA)
Pierre Devaux (THERAXEL) & Julien Triquet (GSK)
Présentation générale des travaux du GIC A3P Annexe 1 : processus de revue et consolidation des commentaires avant envoi à l’EMA. Principales évolutions par rapport à la version actuelle de 2008. Commentaires clés formulés par le GIC A3P Annexe 1 (cover letter). Introduction des thèmes spécifiques qui seront détaillés au cours des 5 prochains webinars (commentaires consolidés):
10 Sept. 2020
17h à 19h30
#2 Contamination Control Strategy (CCS)
Animateurs - Nicolas Bourgeois (GSK VACCINES) & Pierre Devaux (THERAXEL)
  • Retour sur un nouvel élément majeur de l’Annexe 1 « Contamination Control Strategy » : principes et exigences
  • Autres commentaires significatifs de l’Annexe 1 en lien avec CCS (temps process critiques, processus de décontamination…)
17 Sept. 2020
17h à 19h30
#3 Filters & Sterilization
Animateurs - Pierre Devaux (THERAXEL) & Julien Triquet (GSK)
  • Présentation des travaux (commentaires formulés / risques associés) du GIC A3P Annexe 1
  • Evolutions et clarifications apportées par Annexe 1 (filtration stérilisante et PUPSIT)
24 Sept. 2020
17h à 19h30
#4 Clarification on requirements for classification and monitoring of cleanrooms
Animateurs - Nicolas Bourgeois (GSK VACCINES) & Sandrine Favre (OCTAPHARMA)
  • Présentation des travaux (commentaires formulés / risques associés) du GIC A3P Annexe 1
  • Evolutions et clarifications apportées par Annexe 1 (ex : qualification/classification vs monitoring, chapitres 4 et 9)
01 Oct. 2020
17h à 19h30
#5 APS / MediaFillTest & Sterility Testing
Animateurs - Julien Triquet (GSK) & Pierre Devaux (THERAXEL)
  • Présentation des travaux (commentaires formulés / risques associés) du GIC A3P Annexe 1
  • Evolution importante du chapitre 9
08 Oct. 2020
17h à 19h30
#6 Barrier Technologies
Animateurs - Sandrine Favre (OCTAPHARMA) & Julien Triquet (GSK)
  • Présentation des travaux (commentaires formulés / risques associés) du GIC A3P Annexe 1
  • Evolution importante du chapitre 4 (VHP…)
15 Oct. 2020
17h à 19h30

Registration form

Webinars A3P
Revision Annex1 GMP EU  –  v12 . 2020

Once you have filled in this form, you will receive by email all the details on how to connect to the webinar(s).

Price : 1 webinar : 250 € (EXCL. VAT)   //  2 webinars : 500 € (EXCL. VAT)
A3P membership not included

All our webinars are conducted via videoconferencing, which requires a computer with a stable internet connection.

Accessibility

We use TEAMS (Microsoft Office) or ZOOM software to conduct our webinars. These secure and free collaborative platforms allow you to follow and interact with our expert, guests and other participants in the best conditions. These software are compatible with all operating systems (Windows / ios) and offer an online version compatible with many browsers (Internet Explorer, Chrome, Firefox, Safari, etc.).).

The A3P team is at your disposal to accompany you and ensure the proper functioning of your system remotely. To do so, all you need is a computer, ideally with a headset (optional you can use your computer’s micro/audio system) and a stable internet connection.

A few days before the date of the webinar, you will receive an email invitation to access the TEAMS or ZOOM platform. On the “D” day, you will just have to connect via the link. Please make sure to have a quiet and comfortable place to follow this module in the best conditions.

Contact

For further information please contact A3P :

Téléphone : +33 (0)4 37 28 30 40
Email : info@a3pservices.com
Courrier : A3P Formation, 30 rue Pré-Gaudry – Lyon 69007