1 year after the implementation of Annex 1
Forum A3P Spain
VENUE
Hotel SB Diagonal Zero, Barcelona
DATE
November 14th, 2024
Save The Date !
FORMAT
Conferences, Round Table, Workshops, Exhibition
SHARE
The new Annex 1 published on August 25, 2023, is focused on reducing the risks of product contamination in the manufacturing processes of a sterile product, especially when it is an aseptic process and not terminal sterilization. It includes regulatory updates, changes in other chapters of the GMP, use of tools described in the ICH Q9 and Q10 guidelines, aims to eliminate ambiguities and considers advances in new technologies.
The conference will address challenges, learning and experience gained one year after the implementation of Annex 1.
Recognized experts in their field will share their experience and knowledge and give details on what difficulties they have encountered in implementing the new requirements and how they have dealt with them. At the end of the day, you will be able to exchange your concerns and ideas with industry professionals during a round table to better understand the problems and innovative solutions. In this round table, the problems raised by the attendees will be discussed anonymously (attendees are encouraged to propose, beforehand or during the day itself, the issues they would like to be addressed) and the most appropriate options for their resolution will be debated.
Official language of the conferences: Spanish
🎧 Simultaneous translation service 🎧 : Spanish <-> English
🎧 Simultaneous translation service 🎧 : Spanish <-> English
Thursday 14 November
Welcome of the participants
08:15
Introduction
Frédéric PASCUAL - A3P Spain Committee
09:00
Enhancing Contamination Control: A Retrospective and Future-Oriented Analysis in Aseptic Pharmaceutical Practices
Walid EL AZAB - A3P ANNEX 1 Common Interest Group (CIG/GIC)
09:15
Experience of EU GMP Annex I implementation
Neus VALLÈS - GP PHARM
09:45
Coffee Break on the exhibition
10:15
Roadmap to implementation of new Annex 1
Jordi RUANO BOU - HIPRA
11:00
Phasing of Compliance with Annex 1 of a Drug Production Clinical Vaccine Filling Line (Multi-products, Multi-formats, Multi-presentations)
Delphine SIRVENTE & Sylvie AGUILLON - SANOFI
11:30
Partners Workshops - See the proposed workshops
ALSICO - CYTIVA - MARCHESINI - MESALABS - TISELAB
The interactive workshops organized by the partner companies are an opportunity for the participants to familiarize themselves with or deepen their technical approach.
12:00
Partners Workshops - See the proposed workshops
ALSICO - CYTIVA - MARCHESINI - MESALABS - TISELAB
The interactive workshops organized by the partner companies are an opportunity for the participants to familiarize themselves with or deepen their technical approach.
13:00
Lunch on the exhibition
14:00
Annex 1 Implementation. Regulatory perspective
Matilde MORENO GARCIA - SPANISH AGENCY FOR MEDICINES AND HEALTH PRODUCTS (AEMPS)
15:15
Partners Workshops - See the proposed workshops
ALSICO - CYTIVA - MARCHESINI - MESALABS - TISELAB
The interactive workshops organized by the partner companies are an opportunity for the participants to familiarize themselves with or deepen their technical approach.
15:45
Coffee Break on the exhibition
16:45
Round Table
Walid EL AZAB - A3P ANNEX 1 CIG / Neus VALLÈS - GP PHARM / Jordi RUANO BOU - HIPRA / Delphine SIRVENTE & Sylvie AGUILLON - SANOFI / Matilde MORENO GARCIA - AEMPS GMP Inspector
17:15
Conclusion & End of the event
18:00
Partners Sessions
Session 1 – 12:00
Risk Analysis and practical solutions for Pre-Use Post-Sterilization Integrity Testing (PUPSIT) implementation
Ana MEIRE & Marco SANVITO - CYTIVA
"With the latest revision to EU Good Manufacturing Practice (GMP) Annex 1, the need for Pre-Use Post-Sterilization Integrity Testing (PUPSIT) is more important than ever in the context of quality risk management. Implementing PUPSIT can seem daunting and requires a well detailed risk analysis. In this workshop we will review what are the risks associated to the PUPSIT implementation with a focus on the following aspects: IT method, wetting procedure, product dilution and product recovery. We will then analyze practical solution for correct implementation of PUPSIT in Single-use or traditional stain-steel installations, considering single or redundant sterilizing filtration."
Workshop 1
Implementación de un sistema esterilizable para bombas peristálticas
Claudio VITI & Marco CASTALDO - MARCHESINI
Implementación de un sistema CIP/SIP en un grupo de dosificación con bombas peristálticas para asegurar esterilidad y facilidad de montaje
Workshop 2
STOPPERS LIFE CYCLE: from the autoclave to the isolator. An overview of the biological assessment of the most critical phases of stoppers treatment and transfer to an isolator.
Maria Luisa BERNUZZI, Ignacio SANTOS & Eulalia BONCOMPTE SATORRAS - MESALABS & LABORATORIO REIG JOFRE
The aseptic transfer of stoppers from the autoclave, after their sterilization, to the isolator, represents a critical procedure that has to be properly developed to ensure/preserve the sterility of the stoppers along the way. The presentation describes the equipments used for that purpose, the process and the controls done to reach that goal.
Workshop 3
Nuevos requisitos en limpieza y desinfección de salas limpias
Laura YVARS & Laura ALONSO - TISELAB
En este taller haremos una revisión de los nuevos requisitos tanto para la limpieza como la desinfección de superficies pequeñas, superficies grandes, descontaminación aérea y la desinfección en la transferencia de materiales.
Workshop 4
Dudas comunes y errores habituales en el sistema de vestimenta para Zona Aséptica.
Álvaro YEPES - VESTILAB
En esta charla, abordaremos las preguntas y errores más frecuentes en la elección y uso de vestimenta para zonas asépticas, fundamentales para mantener la integridad de los entornos controlados. Revisaremos los fallos típicos en los protocolos de colocación de la vestimenta, comentando las mejores prácticas para minimizar los riesgos de contaminación.
Workshop 5
Session 2 – 13:00
Filter Integrity Testing trouble shooting and Data Integrity compliance
Gloria PONTES & Marco SANVITO - CYTIVA
"According to Annex 1 – Manufacture of Sterile Medicinal Products (2022) - Paragraph 8.82 section vi - "The filtration system should be designed to… Permit in-place integrity testing of the final 0.22 µm sterilising grade filter, preferably as a closed system, both prior to and following filtration as necessary. In place integrity testing methods should be selected to avoid adverse impact on the quality of the product.“ If a liquid sterilizing filter fails integrity test, it could be damaged, but there may be other causes for the failure. Filter failure investigations and retest procedures should be documented. In this workshop we will review troubleshooting actions in case a filter may fail integrity test. We will also review how the Palltronic™ Flowstar V integrity test instrument has been designed with consideration to all 9 ALCOA+ principles, facilitating the detection of unauthorized record editing."
Workshop 1
Implementación de un sistema esterilizable para bombas peristálticas
Claudio VITI & Marco CASTALDO - MARCHESINI
Implementación de un sistema CIP/SIP en un grupo de dosificación con bombas peristálticas para asegurar esterilidad y facilidad de montaje
Workshop 2
Decontamination and validation of an hydrogen peroxide system
Maria Luisa BERNUZZI & Ignacio CANTERA - MESALABS & AZBIL TELSTAR
Hydrogen peroxide is a widespread sporicidal agent and it is often used to decontaminate equipments. A lot of variables can affect the final microbiological result and it is fundamental to know them and to manage them. The technologies, the process, the variables of the process, the "instrument" to validate the process itself (i.e the Biological Indicator); how to obtain the expected microbiological result with a well developed decontamination cycle.
Workshop 3
Trabajo en sistemas de Barrera.
Laura YVARS & Laura ALONSO - TISELAB
En este taller profundizaremos en las particularidades de la transferencia de materiales, puntos críticos y procedimientos de limpieza y desinfección de los sistemas de barrera.
Workshop 4
Claves del EU GMP Anexo 1 en Limpieza y Desinfección: análisis de tendencias y consultas frecuentes.
Inyaki FREIXA - VESTILAB
En esta charla analizaremos las tendencias actuales en limpieza y desinfección en entornos controlados. Analizaremos los aspectos clave del Anexo 1 de las GMP de la Unión Europea a este respecto y resolveremos las dudas más frecuentes, proporcionando claridad sobre las normativas y su aplicación efectiva para un control de la contaminación más robusto.
Workshop 5
Session 3 – 15:45
Developing a sterilising grade filter for high concentration biologics
Victor TOMÁS & Marco SANVITO - CYTIVA
The share of subcutaneous administration over intravenous infusion is increasing. Careful consideration is required when selecting a sterilizing grade filter for drug product filtration. With the development and manufacture of subcutaneous biologics come challenges in the sterilizing or bioburden reduction filtration of drug substance that is both highly concentrated (>100 g/L) and viscous (10-30 cP). In this workshop we will review the main challenges of the manufacture of high concentration biologics, introducing Supor™ Prime sterilizing grade filters, which have been developed to meet these challenges. The high throughput of Supor Prime filters allows for reduced filtration area. By reducing the filter area, a smaller filter can be used resulting in increased product recovery per batch. Supor Prime filters are best suited for sterile filtration in the most critical process steps: post ultrafiltration/diafiltration (UF/DF), bulk fill of drug substance, and final fill of drug product.
Workshop 1
Implementación de un sistema esterilizable para bombas peristálticas
Claudio VITI & Marco CASTALDO - MARCHESINI
Implementación de un sistema CIP/SIP en un grupo de dosificación con bombas peristálticas para asegurar esterilidad y facilidad de montaje
Workshop 2
STOPPERS LIFE CYCLE: from the autoclave to the isolator. An overview of the biological assessment of the most critical phases of stoppers treatment and transfer to an isolator.
Maria Luisa BERNUZZI, Ignacio SANTOS & Eulalia BONCOMPTE SATORRAS - MESALABS & LABORATORIO REIG JOFRE
The aseptic transfer of stoppers from the autoclave, after their sterilization, to the isolator, represents a critical procedure that has to be properly developed to ensure/preserve the sterility of the stoppers along the way. The presentation describes the equipments used for that purpose, the process and the controls done to reach that goal.
Workshop 3
Monitorización Ambiental: elemento clave en la Estrategia de Control de la Contaminación
Santi TINTORÉ & Silvia ASTURIAS - TISELAB
En este taller revisaremos cómo un programa de Monitorización Ambiental que integre los diferentes métodos de monitorización proporciona información sólida, que permite evaluar y tomar decisiones fundamentadas sobre la Estrategia de Control de la Contaminación
Workshop 4
Dudas comunes y errores habituales en el sistema de vestimenta para Zona Aséptica.
Álvaro YEPES - VESTILAB
En esta charla, abordaremos las preguntas y errores más frecuentes en la elección y uso de vestimenta para zonas asépticas, fundamentales para mantener la integridad de los entornos controlados. Revisaremos los fallos típicos en los protocolos de colocación de la vestimenta, comentando las mejores prácticas para minimizar los riesgos de contaminación.
Workshop 5
Map of the exhibition
| Company | N° Stand | Company | N° Stand | |
| MARCHESINI | 1 | STERIS | 12 | |
| ELIS CLEANROOM | 2 | CONTEC | 13 | |
| QUALIPHARMA | 3 | CHARLES RIVER | 14 | |
| NOVATEK INTERNATIONAL | 4 | LITEK PHARMA | 15 | |
| OPTIMA | 5 | MESALABS | 16 | |
| COMSER & ASEPTIC ACADEMY | 6 | VESTILAB | 17 | |
| NETSTERIL | 7 | BECTON DICKINSON | 18 | |
| BIOMÉRIEUX | 8 | REDDITCH MEDICAL | 19 | |
| CYTIVA | 9 | STAXS | 20 | |
| IZASA SCIENTIFIC | 10 | TISELAB | 21 | |
| INSTRUMENTACIÓN ANALÍTICA | 11 | ALBIAN GROUP | 22 |
Services included with the Table Top stand
- The participation of 1 person
- A dedicated exhibition area where you can install your products and communication tools: umbrella stand, roll-up, display, product, …
A basic equipment including a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker - Breaks and meals as indicated in the program
- Illimited Wifi
- A badge that gives you free access to the entire technical and scientific programme.
- The list of participants to the event
Registration form
Participate in A3P event 1 year after implementation of Annex 1
Registration fee: 500€ without VAT (VAT 20%)
CONTACT
Sébastien BOYER:
Phone number: +33 (0) 4 37 28 30 51
Email: sboyer@a3pservices.com
Hotel SB Diagonal Zero
Address: Plaza de Llevant, s/n, Sant Martí, 08019 Barcelona
VENUE
