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Is quality management a weak pillar of the pharmaceutical industry?


The pharmaceutical industry, including medical devices, is one of the most regulated industries in the world. It is not only subject to national constraints, but also to a series of international directives and rules, including improvements in pharmaceutical regulations through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). From a pharmaceutical industry perspective, globalisation, combined with the expansion of outsourced activities, has emphasised the importance of a sound and holistic management of Quality during the Drug Product lifecycle. Quality Management, therefore, plays a crucial role to ensure that the manufactured products are safe and meet the required quality standards for the different markets supplied.

In this context, ensuring conformity for each market during the drug product lifecycle is a real challenge for pharmaceutical industry, which must deliver products of the right quality to patients worldwide in a “cost-effective” way.

The scope of Quality Management is extensive and includes process specifications, qualification of equipment, quality of active pharmaceutical ingredients and excipients, documentation procedures and training of personnel. The control of pharmaceutical products quality can be summarised in six main pillars: Method, Material, Machine, Man, Management, and Environment.

Quality Management plays a crucial role to ensure that the manufactured products are safe and meet the required quality standards for the different markets supplied.

Over the last twenty years, the pharmaceutical industry has started a digital transformation to guarantee full-end-to-end traceability, from raw material reception to the patient and ensuring data integrity. Different electronic systems have been proposed for the different steps of the drug product manufacturing process. All analytical testing can now be managed with a Laboratory Management System, and different activities executed during the manufacturing process are described and recorded in Electronics Manufacturing Services. The traceability of the Finished Drug Product is ensured with the serialisation of each pack.

The COVID-19 pandemic underlined some of the constraints already identified in data digitalisation and it also highlighted the weakness of the pharmaceutical supply chain implemented at the end of the twentieth century. Specifically, it raised underestimated issues of third-party oversight and risk management of critical material when travel was no longer possible. Remote audits and risk management were then implemented and opened the door for new approaches that could fit with the current environment where resources and responsiveness were key, but which had not as yet been the focus ofwhereas pharmaceutical regulations.

These challenges concerning operations performed at all stages of the product lifecycle are continuously impacting Quality Management which must ensure overall compliance.

The pharmaceutical industry must seize these issues and transformations head-on. But well-trained professionals are missing.

In a nutshell, the pharmaceutical industry must address these issues and transformations head-on. However, well-trained professionals are in a short supply. Even though Switzerland is renowned worldwide as a life sciences hub in the healthcare sector and as a global centre for the pharmaceutical industry, there was not until very recently an “education curriculum” in the field of industrial pharmacy that addressed quality management. As a result, companies based in Switzerland had to look for trained professionals abroad.

To overcome this gap, the School of Pharmaceutical Sciences at the University of Geneva, in close collaboration with the Swiss Society of Industrial Pharmacists and the Groupement Romand de l'Industrie Pharmaceutique (GRIP-Pharma), as well as a diverse group of experts from companies based in Western Switzerland, has launched the very first Certificate of Advanced Studies (CAS) in Industrial Pharmacy – Quality Management.

This executive education programme was designed to train professionals in the pharmaceutical industry, a vital driver of Switzerland’s economy and innovation, to become Quality Management experts. By addressing current and new challenges, participants will strengthen the quality pillar of industrial pharmacy and actively contribute to maintaining and further developing the unique Swiss combination of historical and technical expertise in the pharmaceutical and engineering industries, the presence of leading academic institutions, and a stable financial environment capable of making significant investments.