Self-control and co-responsibility: a step forward in stakeholder involvement in control and inspection processes

Self-control and co-responsibility are the result of a new control policy implemented by the FAMHP Directorate General Inspection. This policy is adapted to the different stakeholders according to their sector, with the common goal of making these players more responsible and involved in optimising the inspections and controls carried out by the FAMHP.

The inspection departments are working to roll out this new control policy, which will eventually apply to all the players audited by our agency.

The first self-control system was set up for medical device distributors. The methodology was subsequently adapted and deployed in the public pharmacy sector and, more recently, in the field of medicine and active substance manufacturers. In parallel with these initiatives, the implementation of these principles is planned for medicine distributors in the near future (GDP – Good Distribution Practices) and a feasibility study for the clinical studies sector (GCP – Good Clinical Practices).

Digitisation as a tool for exchanging information and optimising controls

Digitisation plays a central role in information sharing and administrative simplification. The development of a dedicated web portal for each sector optimises the inspection process and its follow-up. The collection and analysis of relevant data exchanged with inspection services and the transmission of inspection reports and CAPA plans (corrective and preventive action plans) are automated, among other things. In this way, the IT system developed becomes a tool for optimising inspection planning and execution. These secure platforms also offer players centralised access to all the documents exchanged with inspection services, simplifying their interactions with the competent authority.

Digital transformation is no longer just a trend; it is an inescapable reality in all business sectors, including public health authorities. It is in this context that self-control and co-responsibility emerge as an essential concept.

For pharmacists in pharmacies open to the public: self-control

“For pharmacies open to the public, the emphasis is on self-control. 2023 marked the culmination of the pharmacy self-control project, carried out in close collaboration between the ICT division, Smals, the Dispensing Division and the legal department,” explains Alain Denis.

This project led to the publication of a Royal Decree in September 2023, with various components.

Firstly, confirmation of the obligation for pharmacists to carry out a self-assessment.
Pharmacists are required to carry out an annual self-assessment of their compliance with Good Pharmacy Practices. The conclusions of this self-assessment enable them to identify areas for improvement and put in place an action plan to further enhance quality within their pharmacy.

Secondly, every pharmacy is required to undergo an external audit once every four years.
The agency is not involved in carrying out this audit, which does not replace a control or inspection. It is carried out by auditors who meet the different criteria set out in the decree. This is part of a coaching approach, helping pharmacists to identify and implement areas for improvement.

Thirdly, pharmacists are now required to complete a form on the FAMHP web portal, covering the activities and structure of the pharmacy. The information collected via this form, along with other relevant data on each pharmacy, is integrated into a risk analysis tool developed by the agency. A risk profile of pharmacies is therefore drawn up to guide inspections, helping to rationalise the controls to be carried out and make them more efficient.

The Dispensing Division was heavily involved in this project. In addition to Alain Denis, three of his colleagues were actively involved. “This project is a good example of cross-functionality. Its implementation required the involvement of not only the inspection departments, but also the IT department, which developed the web portal module, and the legal department, which drafted the royal decree.”

Alain Denis – Margriet Gabriels – Alain Bya

Co-responsibility for Good Manufacturing Practices

Good Manufacturing Practices (GMP) are the principles and guidelines for the manufacture of medicines for human and veterinary use. This field covers a wide range of players, including manufacturers of active substances, production intermediaries and finished products (medicines), suppliers of the raw materials used in pharmacies and manufacturers of officinal preparations. In 2023, the implementation of the GMP co-responsibility project led to the development of a web portal for manufacturers of medicines and active substances. This tool was developed in close collaboration with the ICT department and Smals. Furthermore, the functionalities implemented have been tested with the involvement of industry stakeholders. Amanual has also been written to facilitate access to and use of this new tool by the different players involved.

The tool has been used for routine inspections of manufacturing sites since the end of 2023. The portal involves stakeholders in the entire inspection process, from planning to closing an inspection, including the transmission of the data used for preparation, the communication of reports and the review of CAPA plans.
It also enables relevant information to be collected for risk analysis purposes. In this way, the IT tool developed is used for optimising inspection planning and execution.

The GMP project will continue to evolve. Other functionalities will be added to the tool, such as the integration of investigations and inspections carried out as part of a manufacturing authorisation application, as well as administrative follow-ups such as the issue of GMP certificates, etc.

Karin Froidbise, Head of the Industry Division, believes that “this tool improves the control process while offering stakeholders an intuitive interface. This vast effort to dematerialise the inspection mechanism could serve as a basis for other sectors.”

Process optimisation for all

There are many benefits: process optimisation, improved data quality and processing, and consolidation of different information into a single interface. In addition, forms relating to controls and inspections are accessible to the inspected parties, access is secure and use is simplified and standardised across different sectors.

Feedback from stakeholders has been positive. Stefanie Scheerlinck from the Industry Division: “We have not had any negative feedback on the implementation of this system. Stakeholders are keen to centralise the information they pass on. The user aspect was taken into account and adaptation was easy.”

Nicolas Mortier of the Industry Division points out: “It was essential to translate all our inspection processes into a single IT system. The work carried out with the ICT Division has proved essential. This digitalisation makes it easier for us to exchange data with our stakeholders and also enables us to manage our business more efficiently.”

Stefanie Scheerlinck – Ethel Mertens – Karin Froidbise – Nicolas Mortier

Our FAMHP experts

Alain Denis is an inspector in the Pharmacies Open to the Public Unit of the Dispensing Division within DG Inspection. This Division controls pharmacies open to the public, hospital pharmacies and veterinary depots.
Karin Froidbise is Head of the Industry Division within DG Inspection. She is responsible for self-control and co-responsibility projects in the fields of GMP and GCP.
Nicolas Mortier and Stefanie Scheerlinck are inspectors in the GM(D)P unit of the Industry Division. They are both involved in the GMP co-responsibility project.