By Carmen Garcia
The Quality Innovation Group (QIG) is an operational expert group of the EMA set up to support the translation of innovative approaches to the design, manufacture, and quality control of medicines, to develop new therapies, and to help improve the supply of existing medicines to patients.
The QIG holds listen-and-learn focus group meetings with stakeholders from industry, academia, and international regulators to discuss the regulatory challenges developers face regarding innovative products, processes, control strategies, and facilities and identify potential solutions together.
Carmen Garcia, EIPG Vice-President of Technical and Professional Development, attended the third listen-and-learn focus group meeting on “process models for pharmaceutical manufacturing” as a representative of the EIPG.
The objective of the meeting was to discuss critical points identified from the stakeholder’s comments and case studies showing the applicability of the considerations included in the document published last February on the EMA website.
The document addressed preliminary considerations (general principles) for process models, reflecting the use of performance-based approaches in pharmaceutical manufacturing processes, as how should the risk to product quality be considered when determining what data is to be included in the dossier in terms of model justification; what data is expected in the dossier in terms of model description and scope; what data is expected to be included in the dossier in terms of model validation and what data is expected in the dossier in terms of process model lifecycle. After the first overview of major comments received during the public consultation presented by a member of the QIG, several representatives of the EFPIA, ISPE, and some pharmaceutical companies presented and discussed the detailed points of the document in a very proactive way, including several examples of specific case studies. As in previous meetings, the minutes of this meeting will be posted on the EMA website.