Good Manufacturing Practice (GMP) governs production sites in the healthcare sector: the pharmaceutical industry, medical devices and certain subcontractors. It sets precise requirements for the quality, traceability and safety of the products manufactured.
This guide presents the key principles of GMP, its real scope and its practical implications for the Quality, Workplace and IT teams at the sites concerned.
What exactly is GMP?
GMP is a set of rules defined at European level and transposed into the French Public Health Code (Code de la Santé Publique). It covers the entire manufacturing process: premises, equipment, personnel, documentation and traceability.
Its objective is simple: to ensure that every product manufactured meets the same quality standards, whatever the production site. This is the framework that the ANSM (France’s medicines and health products regulator) checks during its inspections, site by site, according to a schedule specific to each establishment.
Contrary to popular belief, GMP is not limited to production rooms. It also covers peripheral areas whenever they could have an impact on the manufacturing chain: changing rooms, access-control airlocks, meeting rooms located in controlled areas and the movement of contractors.
Who is responsible for applying it?
The Responsible Pharmacist (Pharmacien Responsable, the pharmacist legally accountable for the site) personally guarantees GMP compliance at their site. This responsibility requires their signature on any change affecting production, the movement of personnel or access to classified areas.
No change of organisation or tool should be decided without their involvement from the outset. This is a key difference from other sectors, where compliance is often the responsibility of a wider Quality team, without such direct individual accountability.
In practice, this means that a project led solely by the Workplace department or the IT department, without Quality approval from the scoping stage, is exposed to a late-stage blockage, often after several months of development.
Traceability requirements at the heart of GMP
Traceability is the most fundamental requirement of GMP. Every action that has an impact on the controlled area must be able to be reconstructed: who, where, when and with what authorisation.
This requirement applies to manufacturing processes as well as to related matters, whenever they involve movement within the controlled area:
- Staff access to sensitive areas
- Movement of visitors and contractors
- Booking rooms in classified areas
- Access logging for audit purposes
A paper register remains compliant in principle, but it quickly shows its limits on a multi-building site or during an inspection covering several months of history. It is often this specific point that prompts Quality teams to consider digitising their tracking.
The case of multi-site groups
A group operating several production sites faces a particular difficulty: each site is inspected separately by the ANSM, with no consolidated view at group level.
What is compliant at one site may be a non-conformity at another. Without centralised oversight, these discrepancies remain invisible until the next inspection, and therefore until they become a documented problem.
This situation creates tension for group Workplace departments: standardising practices improves risk control, but each site retains its own local specificities (architecture, history, requirements specific to its Responsible Pharmacist) that a single tool must respect without overriding them.
What a digital project must respect
Any digitisation project affecting a GMP site must meet four requirements.
- Prior Quality approval by the site’s Responsible Pharmacist
- Stronger traceability, never weakened by the new tool
- Auditability, with data export in a format that can be used during an inspection
- Consistency with existing frameworks, without duplicate documentation
A tool that does not tick these four boxes, however user-friendly it may be, will slow the project down rather than speed it up. Conversely, a tool designed with these constraints from the outset makes Quality approval easier rather than delaying it.
Why digitise despite the constraints
On a GMP site, the temptation is sometimes to keep existing practices rather than reopen a Quality approval file. This caution is understandable, but it comes at a cost: a paper register or disparate tools across sites make it harder to reconstruct a history during an inspection and lengthen the time taken to respond to ANSM requests.
A well-designed system, approved in advance by the Responsible Pharmacist, reverses this logic. It does not replace Quality governance; it provides the elements, such as time-stamped logs, documented access rights and ready-to-use exports, that make demonstrating compliance quicker, without manual reconstruction before each audit.
Groups that succeed with this type of project have one thing in common: they involve Quality from the scoping stage, not at deployment. The time saved is measured less by the installation of the tool than by how smoothly the subsequent audits run.
A point to watch
Software alone does not guarantee GMP compliance. In fact, the frameworks do not explicitly mention space or access management tools: it is their use, such as access to a classified area or movement within a controlled area, that brings them within the scope of inspection.
This classification must be confirmed site by site with the Responsible Pharmacist concerned, rather than assumed in advance on the basis of a product sheet alone.
In summary
GMP structures the compliance of healthcare production sites around three pillars: traceability, the individual accountability of the Responsible Pharmacist, and consistency between sites for multi-site groups. Every project, digital or not, must fit within this framework from the design stage rather than being adjusted to it after the fact.