6.4. The long term perspectives for a comprehensive PQS serving both, drug development and design & development of medicinal devices

Another identified threat is the lack of a management system complying with a PQS as described in ICHQ10. This is essential to establish a systematic approach for Knowledge Management, change management, management review and continual improvement and needs to be built in the organisation. A continuous interaction between QA and development is an additional backbone to the traditional QA driven quality system, which every company already has to achieve CGMP compliance.

An extended PQS is very much also to the heart of the relevant ISO guidelines for the design & development of medicinal devices. A joint system approach can thus be selected for both, medicinal devices and drug products, thereby avoiding problems with the definition of interfaces, reducing duplication or an overlap of processes and systems and improving the overall impact of such a joint Pharmaceutical Quality System on the quality of all products. The approach selected to do so is described in Figure 13, which demonstrates the symbiotic approach pursued by a PQS that can handle both needs and also fulfils the regulatory requirements for both, QbD driven development of drug products and ISO13485⁶⁷ compliance for the design and development of medicinal devices. The roll out of such a PQS can also be planned as a stepwise approach serving both product groups and employing joint SOP systems where applicable while clearly differentiating between drug product specific SOPs and SOPs for medicinal devices. This will achieve the integration of the essential QbD aspects of management review, management responsibility, change control, process monitoring, Knowledge Management and Continual Improvement into the architecture of the organisation. At the same time it enables development of medicinal devices and/or drug/device combination products which have to comply with the ISO guideline.

development - a R&D quality management system" class="wp-image-10049 size-full" height="352" src="https://sgbs.ch/wp-content/uploads/Figure-13-Integrated-PQS-for-drug-products-and-medicinal-device-development-a-RD-quality-management-system.png" width="601"> Figure 13: Integrated PQS for drug products and medicinal device development - a R&D quality management system⁶⁸

⁶⁷ ISO 13485 Medical Devices
⁶⁸ Source: author