COMSER & ASEPTIC ACADEMY

20th September

12:00 – 14:00

Farmaforum Workshop Room 2

Como tener el proceso de fill and finish de un producto liofilizado controlado (GMP Anexo 1). Des de la cualificación del diseño al desarrollo del proceso de liofilización y la validación del proceso

Speakers:

Ricard Castillejo (Founder and CEO of ASEPTIC ACADEMY)

Alfons Ubach (Business Development Director at COMSER)

María Aguilar (Head of Lyophilized Product Development Services at COMSER)

Jaume Vallet (CEO at COMSER)

Summary:

The control of the fill and finish process of a freeze-dried product has two major challenges:
1.- The maintenance and demonstration of the asepsis of the process.
2.- Ensuring the non-degradation of the product during the whole process.

This workshop aims to analyze all the concepts to be taken into account to achieve these challenges in the simplest and most robust way possible with a very practical approach based on our experience in four key areas of knowledge:

– Regulatory knowledge: providing criteria for the implementation of a robust system following the criteria defined in the GMP Annex 1 regulations.
– Knowledge of lyophilized products: Provides criteria to identify the conditions that the product can withstand and therefore define and validate the appropriate manufacturing processes.
– Process knowledge: Provides criteria to identify the main risks to be taken into account during manufacturing and to define the critical qualification and requalification tests to be performed on the equipment.
– Equipment knowledge: provides criteria to identify the limits of industrial equipment to take into account for the development of the appropriate formulation, as well as the design of the lyophilization process.

We will address the following topics:

– Implementation of the contamination control strategy (CCS).
– Impact of manufacturing area design for contamination control.
– Main tests to be considered for the qualification and requalification of critical equipment.
– Formulation and development of the freeze-drying process.
– Validation of the main processes.
– Qualification of personnel.
– Validation of the media fill process (APS).