cGMPs in Fill & Finish

This activity reviews the general principles of data integrity and highlights their importance, while presenting the impacts and consequences of failing to comply with these principles in a Fill & Finish context, in accordance with Good Manufacturing Practices (GMP).

This interactive activity places the user in the role of an operator facing typical situations to identify the general principles of ALCOA+, apply Fill & Finish procedures in compliance with data integrity requirements, report non-conformances, and explain the consequences of non-compliance.

This interactive activity engages the user in analyzing the benefits and risks associated with data digitization in a pharmaceutical context, while guiding them to apply the appropriate behaviors to ensure the compliance of digital data during Fill & Finish operations.

This interactive activity places the user in typical scenarios within a cleanroom to identify the appropriate behaviors to adopt in order to minimize contamination risks, and to explore the main control techniques implemented in Fill & Finish operations.

This interactive activity, structured into three missions, immerses the user in the essential steps of an intervention in a production area. It covers gowning procedures for accessing Grade C and A areas, checks in the material transfer airlocks and Fill & Finish zone before start-up, the right practices to adopt during operations under an laminar airflow hood, and the final checks to be performed at the end of the operation to ensure compliance with Fill & Finish requirements.