When Pharmaceutical Companies Become Food Business Operators: Quality Management from Different Perspectives!

Pharmaceutical companies are increasingly expanding their portfolios to include food products such as dietary supplements. With this expansion comes an immediate and far-reaching obligation to comply with all regulatory requirements in the food sector. This raises a central question: How can a food quality management system (QMS) be sensibly integrated into an existing pharmaceutical QMS, or is it better to develop them in parallel? 

A Brief Overview of the Regulatory Framework in the Food Sector!

The General Food Law Regulation (EC) No. 178/2002 defines the basic principles of food law in the EU. It stipulates that food must be safe and traceable back to the primary production stage. This regulation is complemented by the Hygiene Regulation (EC) No. 852/2004. Together, they establish Good Hygiene Practice (GHP) and Hazard Analysis and Critical Control Points (HACCP) as mandatory standards. The Codex Alimentarius, an international reference by FAO/WHO, provides global guidelines for hygiene standards and food quality.

When is a Food QMS necessary?

In the pharmaceutical sector, the GxP environment prevails: GMP, GDP, GVP. It focuses on clinical trials, manufacturing practices, batch release, and vigilance. In contrast, the food sector prioritizes consumer protection, hygiene, and traceability. Processes must be documented, but not to the same extent as for pharmaceuticals. Responsibilities also differ: there is no "Qualified Person," but rather the food business operator who is liable for compliance.

Pharmaceutical companies that include dietary supplements in their portfolio – whether through manufacturing, storage, or distribution – automatically become food business operators. This means they are subject to food law requirements, regardless of their internal structure or production level. A functioning food QMS is not only legally required but also crucial for product safety and consumer protection.

The heart of every food QMS is the HACCP concept (Hazard Analysis and Critical Control Points). Companies must identify, assess, and control potential hazards to food safety through suitable control points. This involves not only microbiological, chemical, or physical risks but also hazards that play a minor role in the pharmaceutical sector, such as allergens.

Those coming from the pharmaceutical field will recognize a lot in Good Hygiene Practice (GHP): documented procedures, training, hygiene concepts, incoming goods inspections, and more. However, GHP is less formalized than GMP. The lack of strict protocols may give the impression of significant freedom in interpretation. In many cases, adapting to the complexity of one’s own operation is not only possible but even desired. However, this flexibility also harbors risks in the event of a crisis, especially since the food business operator cannot be released from liability.

Conclusion: Integration with Strategy!
A food QMS cannot simply be seen as a "light" version of GMP. Anyone looking to merge both systems must understand where the regulatory priorities lie. For pharmaceutical companies, this means: new roles, new responsibilities, but also opportunities through the HACCP perspective. With the right approach, an integrated QMS can be built that covers both worlds – efficiently, safely, and in compliance with the law.

Are You Planning to Enter the Food Market?
We support you in establishing and/or integrating a legally compliant food QMS into your existing structures. Contact us – we bring together expertise in both food and pharmaceutical quality management.