In Belgium, all homeopathic medicines must be registered and must meet stringent quality requirements. Heel Belgium has opted to be streets ahead and has already been working with Quality by Design for five years now. And successfully so.

Veronique De Coen
Veronique De Coen, Heel Belgium

The company has managed to obtain approval for the Oculoheel eye drops as well as for the Traumeel medicine. Veronique De Coen, Quality Manager, tells us that the registration of homeopathic medicines is important for all the parties concerned. “Not only for the patient, but also for the doctor in order to have confidence in the product, and also for the manufacturer. After all, if your product is registered, you can promote it.”

High Quality Requirements

Is the quality issue for a homeopathic manufacturing company different compared to other pharmaceutical companies? Quality Manager Veronique De Coen nods in approval and explains: “Yes, it is. Homeopathy combats a disease by prescribing medication that triggers identical symptoms in a healthy person. The treatment method stimulates the body’s natural capacity for self-healing. Homeopathy uses mother tinctures of mineral, vegetable or animal origin. These raw materials may be harmful when undiluted. That is why they are diluted step by step.”

“This is an important factor in terms of the quality inspection. In traditional pharmacy, one has a set quantity of raw material to produce a set quantity of tablets, gels or drops. In homeopathy these quantitative checks do not apply. The quality control is based solely on the production method and the procedures. These are subject to strict regulations.”

Veronique elaborates: “In Belgium, we have very stringent quality requirements for homeopathy. They cover both the processes and the equipment, but also the suppliers of the raw materials, the additives and the packaging materials. Thanks to a new impetus at FAMPH, the registration process for homeopathic medicines is now much more efficient. Major changes have been implemented, for example, in terms of the expiry dates for raw materials and the way in which the materials are processed.”

Driving Force for Growth

Heel has taken the conscious decision to collaborate with QbD in order to improve staff recruitment and training. “We collaborate on a flexible basis, which helps us to keep our costs down. QbD is a real specialist in the field of quality control. They have in-depth knowledge of the requirements and of the processes, and also of the homeopathy industry. Their staff provide back-up and are an extension to our own team.”

The QbD consultants work in close liaison with our own team of specialists, and they can also turn to them if need be. Veronique considers this to be a great advantage. “As a result of this sum total of knowledge, we can now already work in anticipation of upcoming inspections. We know exactly what is expected and we view any impending changes as new opportunities. This shows proof of our drive, our commitment and good faith, and this vis-à-vis FAMPH, our parent company and our customers. Our attention to quality therefore becomes a driving force for growth.”

Team Spirit

QbD has performed audits, quality reviews and has fine-tuned the training procedures. Veronique says: “We now make use of a matrix, which gives us a clear overview of who is monitoring what, and the procedures people need to know. This is useful for new members of staff and for people standing in for a colleague on sick leave.”

Our collaboration with QbD has grown over the last five years. “The QbD consultants are more than just a group of outside contractors working separately on a number of clearly defined tasks. On the contrary, we have a real team spirit. It just clicks. We have worked together intensively and will continue to do so in the future. This means that we can confidently look forward to the 2015 FAMPH inspection with full of peace of mind.”

“Quality must form an integral part of the processes, staff training, and change management. There is simply no end to quality management. It takes a lot of energy, day in day out, so one has to be very resilient. Sometimes quality managers may be too proud to ask for help from outside. However, an external partner such as QbD broadens our outlook, eases any chronic pain, and lightens our load. Just like an approved drug. There is only one drawback: it is not reimbursed by your health insurance.”

Heel Belgium: Facts & figures

  • Heel Belgium is active in bioregulatory medicine and traditional homeopathy. The company is the second producer of homeopathic medicines in the world.
  • World-wide, the group employs a 1,300-strong workforce. Heel Belgium has 60 employees, and is a subsidiary of the German parent company in Baden-Baden.
  • The Belgian range consists of 800 remedies, available in various pharmaceutical forms, i.e. drops, tablets, granules, creams, gels and syrups.
  • For Heel, quality management has always been a highly important factor. As early as in 1985, the company became an accredited pharmaceutical laboratory. In 1996, Heel was also the first homeopathic company in Belgium to comply with the Good Manufacturing Practice standard.
  • Heel is one of the few companies in the industry to show positive growth figures: 7.5% growth in the core business.

Focus on 7 Areas of Work

QbD and Heel currently collaborate on the basis of audits and continuous process assessment, focusing on seven areas of work:

  • Eliminating discrepancies for inspection purposes
  • Anticipating FAMPH comments
  • Cleaning certification
  • Equipment certification
  • Process certification
  • Supplier assessment
  • Training courses

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