Good Manufacturing Practices (GMP) provide a framework for production sites in the healthcare sector, including the pharmaceutical industry, medical devices, and certain subcontractors. They establish specific requirements regarding the quality, traceability, and safety of manufactured products.
This guide outlines the key principles of GMP, their actual scope, and their practical implications for the Quality, Workplace, and Information Systems teams at the relevant sites.
What exactly are GMPs?
GMPs are a set of rules established at the European level and incorporated into the Public Health Code. They cover the entire manufacturing process: facilities, equipment, personnel, documentation, and traceability.
Their goal is simple: to ensure that every product manufactured meets the same quality standards, regardless of the production site. It is this set of standards that the ANSM monitors during its inspections, site by site, according to a schedule specific to each facility.
Contrary to popular belief, GMPs are not limited to production areas. They also cover peripheral areas whenever they have a potential impact on the manufacturing process: locker rooms, access control stations, meeting rooms located in controlled areas, and contractor traffic.
Who is responsible for enforcing them?
The Responsible Pharmacist is personally responsible for ensuring compliance with GMP at his or her facility. This responsibility requires his or her signature on any changes affecting production, staff movement, or access to restricted areas.
No decision regarding organizational changes or tools should be made without his or her involvement early on. This is a key difference from other sectors, where compliance is often the responsibility of a broader 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 phase onward—risks being stalled at a later stage, 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 traceable: who, where, when, and with what authorization.
This requirement applies to both manufacturing processes and related matters, provided they involve movement within a controlled area:
- Staff Access to Sensitive Areas
- Visitor and Vendor Traffic
- Reserving Rooms in a Designated Area
- Access Logging for Auditing Purposes
A paper-based log generally remains compliant in principle, but it quickly reveals its limitations at a multi-building site or during an inspection covering several months of history. It is often this specific issue that prompts quality teams to consider digitizing their tracking processes.
The Case of Multi-Site Groups
A group that operates multiple production sites faces a particular challenge: each site is inspected separately by the ANSM, with no consolidated view at the group level.
What is considered compliant at one site may be a non-compliance issue at another. Without centralized oversight, these discrepancies remain unnoticed until the next inspection—and thus until they become a documented problem.
This situation creates a challenge for the Group’s Workplace Departments: standardizing practices improves risk management, but each site retains its own local characteristics—such as architecture, history, and requirements specific to the Pharmacist in Charge—which a single tool must accommodate without overriding them.
What a digital project must adhere to
Any digitization project involving a GMP-compliant site must meet four requirements.
- Prior Quality Approval by the Site's Chief Pharmacist
- Enhanced traceability, never compromised by the new tool
- Auditability, with data export in a format suitable for inspection
- Consistency with existing standards, without duplicate documentation
A tool that doesn't meet these four criteria—no matter how user-friendly it may be—will slow down the project more than it will speed it up. Conversely, a tool designed with these constraints in mind from the outset facilitates quality validation rather than delaying it.
Why Go Digital Despite the Challenges?
At a GMP-compliant site, there is sometimes a temptation to stick with existing practices rather than reopen a quality validation file. This caution is understandable, but it comes at a cost: paper records or tools that vary from site to site make it difficult to reconstruct a history during an inspection and prolong the response time to requests from the ANSM.
A well-designed system, validated in advance by the Chief Pharmacist, reverses this approach. It does not replace quality governance; rather, it provides the necessary elements—such as time-stamped logs, documented access rights, and ready-to-use export files—that make it faster to demonstrate compliance, without the need for manual reconstruction before each audit.
Groups that succeed in this type of project have one thing in common: they incorporate quality right from the scoping phase, rather than at the time of implementation. The time saved is measured less by the installation of the tool than by the smoothness of the subsequent audits.
Something to Keep in Mind
Software alone does not guarantee GMP compliance. In fact, the guidelines do not specifically 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 control.
This qualification must be confirmed on a site-by-site basis with the responsible pharmacist, and should not be assumed in advance based solely on a product information sheet.
In summary
Good Manufacturing Practices (GMP) structure compliance at healthcare production sites around three key areas: traceability, the individual accountability of the Responsible Pharmacist, and consistency across sites for multi-site organizations. Any project, whether digital or not, must be designed within this framework from the outset rather than being adapted to it after the fact.