Rutland Biodynamics Ltd., is believed to be the only farm run by a qualified herbalist to be accepted for licensing under the Traditional Herbal Medicines Directive (THMD), anywhere in the whole of Europe.
In the main, GMP means that the level of safety of our products is guaranteed extremely high and the chance of errors very low. As we also have complete control over what we grow, we are uniquely able to choose the quality of many of our raw materials, in ways that conventional processors handling internationally traded dried commercial material are not.
GMP for medicines is an international convention applying the same criteria to all companies, large or small, across the world, and so the challenges for small companies are considerable. (More detail can be found at www.picscheme.org).
The greatest commitment for us has been to the ‘invisible’ parts of the system, such as specially written software which we have been developing for years, as well as the unremitting commitment to audit trails of everything from bottle tops to the quality of staff training. Everything manufactured inside is done so with purified (filtered) artesian well water and in a filtered air atmosphere. Every batch of every component and ingredient can be traced from its origin – mainly from our own certified biodynamic organic fields and hedgerows – to its final delivery address.
What this means for you, the customer, is total peace of mind that everything leaving Rutland is subject to as many checks as possible, and in the event that something is found to be not right, that we are able to respond in an appropriate and timely fashion.
Because GMP is essentially adopted from chemical science (and because herbs cannot be defined adequately by chemistry), it puts a lower limit on what herbalists usually call ‘quality’, although this is done in a very ‘cast-iron’ way indeed. Nevertheless, in the course of our investigations, we have been surprised by the extent of substitution and adulteration of imports (usually innocent mistakes), and it is essential to realise that these can go quite unnoticed unless GMP checks are in place. Moreover, within Rutland’s own GMP system, we have also paid a great amount of attention to being able to consistently reproduce the quality of our fresh biodynamic organic herbs in every bottle which leave our premises.
Some people may think that biodynamic growing and pharmaceutical regulation are odd bed-fellows. We would have to agree. Our job, however, is to work continuously to promote mutual understanding and make these better companions. Indeed the first thing the MHRA Inspection team did when they visited us in 2006, was to express interest in biodynamic methods. It was a good start! This is not only a matter of protecting our beliefs and traditional ways of working with Nature’s whole plant medicines, but it is as much about bringing traditional healing materials into the forefront of modern society, which suffers so many ills.
The named QP or Qualified Person has the responsibility of passing the quality of products as being fit for release for sale. Normally this is done under the law by a member of the Royal Chemical Society employed on behalf of a company, but Rutland is not only the first farm, but may be currently the only producer anywhere where one QP is a qualified herbalist (MNIMH & CPP), another a forensic scientist and third a fellow of the Royal Pharmaceutical Society!
All this is important as it helps us maintain the essential links between what we do, and how, and why we do it. These are the all too often missing links, which we call ‘quality’.