What has current Good Manufacturing Practise (cGMP) got to do with herbal “Quality”?
Click cGMP Certificate to see our current Dept. of Health manufacturing licence.
cGMP is basic common manufacturing sense formalised into an international pharmaceutical convention covering every aspect of ‘current Good Manufacturing Practise’ and its consequent ‘quality assurance’. The main plank of cGMP is inspection by the national body responsible for enforcement of quality standards in medicines which in our case, is the British Government Department of Health’s MHRA. cGMP quality is about checks and balances to ensure that the systems used by a company to make and distribute medicines are fit for purpose, rigorously applied and followed without uncontrolled deviation. This is checked and audited by vigorous regular inspections by the government regulatory inspectorate (MHRA).
Practitioners need to be aware that there have, unfortunately, been untruthful claims by some UK Companies dishonestly claiming cGMP but which do not have an ‘MIA’ licence number and do not appear on the MHRA website and are not cGMP approved for medicines. These same companies are those which may supply contaminated or even incorrect ingredients to unsuspecting practitioners. You can easily check this by asking for a copy of the cGMP certificate, which should look something like ours.
Rutland Biodynamics was founded by a qualified practitioner and later Council member of the National Institute of Medical Herbalists, for the single reason that the practitioner has a duty of care to their patients in the choice and quality of their medicinal ingredients.
cGMP therefore formalises and assures those things that any manufacturer ought to be doing at the very least, with the most vigorous possible independent audit by government inspectors. cGMP is a also minimum legal base line defining fitness of goods to be released to the market, and is widely regarded as giving the practitioner the legal defense of due diligence.
cGMP includes an independently approved and checked testing system that does not in itself improve quality, but which at least guarantees minimum standards of traceability, raw materials, manufacturing and testing, by very thorough auditing and strict licensing protocols. These things are absolutely essential aspects of quality, although they are not, in the herbal sense, sufficient alone. Unfortunately, many herbs are still sold in the UK which do not even reach these minimum standards and this threatens the whole future of the herbal profession.
cGMP controls starting materials, intermediates and finished goods.
How can a Pharmaceutical System like cGMP be applied to herbs?
cGMP is an entirely pharmaceutical system, based on principles of chemistry and microbiology. In the European Pharmacopoeia, however, herbs are defined special examples of ‘active ingredients’ by which the whole herb and not just components are held to define quality. Physical and chemical components are, however, just one way in which the quality of the herb must be checked. There are many other ways and we have been involved for many years with methods developed by anthroposophical scientists researching biodynamic qualities.
This is because we understand that herbal medicine quality remains dependant on some qualities of the herbs used at the start that are not something that are not adequately defined by current chemistry. Rutland Biodynamics has therefore invested considerably over the years in developing an understanding of underlying issues of herbal quality (For more details, please click here).
The overall generic legal definition and description of herbal medicines as complex entities can be found towards the front of the European Pharmacopoeia.
Traditional herbal quality, nevertheless, is a concept of efficacy that remain distinct from the checks and balances that comprise cGMP. This is a highly complex attribute that conventional science has only begun to elucidate. The experimental development of metabolomic techniques of ‘fingerprinting’ hold out hope of better laboratory methods for the future. Work has been ongoing in some centres (such as Reading University) to understand the nature of synergy. How this may be translated into herbal quality is still hard to define, although we have done considerable original work in this regard. Our webpage: Are fresh extracts really better? explains how the surface activity of microemulsions might be a key element in the results obtained from the climbing picture, capillary dynamolysis or ‘steigbildemethode‘ developed by anthroposophical scientists. This may help to unravel the mystery surrounding the vitality of ‘good quality’ herbal extracts.
Fresh vs. Dry Qualities
Nicholas Culpeper pointed out something of a dilemna, some three centuries ago: he noted that the best herbs are those picked green and full of juice, but that they are the worst for drying and keeping.
In the modern age, the comparison of the qualities of rehydrated, dehydrated foodstuffs with those of fresh fruit and vegetables seems an obvious analogy to draw between fresh and dried herbs. In nutrition, therefore, the answer to the matter is one of unanimous verdict of both lay and scientific opinion – fresh is always better than dried!
Yet, because the origins of the (eventually Royal) Pharmaceutical Society lay in the development of the science of analysis of the exotic dried herbs that came to London by land and sea at the height of the British Empire, so still the texts are copied from generation to generation, slavishly and unquestioningly continuing to labour it’s out of date and illogical conclusions.
Perhaps we should not be surprised to know that the origins of the pharmaceutical industry lay in the belief that dried herbs are more useful than fresh herbs because of the 19th century idea that they must be ‘more chemically concentrated’. That is how we have all been conditioned throughout the last hundred or so years. Yet, it is the case that although plants do contain’ active’ chemicals, plant physiologists have realised for more than a quarter of a century that most plants potentiate their biological activity by high organised and extraordinarily complex ecological adaptations. It is hardly a great leap of imagination to see that these extraordinarily complex ecological adaptations are, generally, exactly what it is that sets whole plants apart from chemical components in their use in medicine. (For more detail, see the scientific paper at this link: Plants, tinctures and colloids). These systems appear to depend largely on complexes of plant proteins, sugars and lipids, that in turn are dependant on water for their structural integrity. Although drying herbs allows them to be kept in a dry state for long periods of time (as is required for the purposes of commerce), this method of preservation depends upon the process of ‘denaturing’, or destroying, the very subtle web of physical phyto-chemical structures that evolution has created over countless millennia in order to enhance biological activity. Life was not designed to protect dead tissues – biological life is the ultimate system of competitive self-preservation!
So there are twin tracks to follow in the making of herbal medicines. There is the matter of ensuring sufficient concentration of ‘active’ molecules and there is the matter of ensuring natural solyphilisation.
Traditional extraction methods
We use traditional macerations methods because both experience and the literature shows that these make the best quality extracts.
According to the 19th century textbooks, plain percolation was invented at a time when concentration of chemicals was all the rage and simply in order to cut costs and increase the manufacturer’s margins. Traditionally percoaltion is a rapid and cheap extraction process that takes the herb to the point called “exhaustion”. It is noteworthy that the British Pharmacopoeia require that (a) percolation is anyway preceded by (strong) maceration and (b) must be followed by concentration by boiling!
Modern herbal science would not normally approve of boiling because of the damage done to the herbal complexes, described in the paragraphs above.
At Rutland, we have discovered that often up to half of the dissolved solids in herbal medicines may consist of amphiphilic molecules, such as glycolipoproteins. These play an essential role in the biochemistry of extracts but are damaged by boiling. For all these reasons, therefore, we do not support methods dependent purely on percolation.
Instead we use an adaption of the traditional practice of daily shaking, that we call our ‘rolling barrel method’. Macerated barrel are simply rolled through 180° every day for a period of many weeks to ensure even mixing as the active micro-structures are released.
Why different varieties of strengths?
Plants are natural products and, being natural products, are extremely flexible in how they work. There are no hard and fast rules about how to arrive at a correct strength for extraction and therefore this area can be a bit daunting to investigate. Usually there is no absolutely ‘correct’ extract but a range of flexible options. We have always tried to work with natural flexibility wherever we can. Although a few people tend to find this puzzling, our very wide range of extracts has been developed over the years together with some of the nation’s most experienced herbalists. There are many different factors to take account of when selecting extraction parameters. Other reasons of individual preference include preferring differing alcohol strengths, for reasons varying from those given by the 19th century physio-medicalists, to modern technical reasons such as preferential solubility coefficients of perceived active complexes. More often, it is what the practitioner is used to using – and that can vary from practice to practice and from school to school. Many parallel traditions have evolved over the years, from the ‘official’ Pharmacopoeia to other strengths popularised by various teachers. Many strengths evolved with manufacturers who sought a way of maximising profit because certain strengths do not require nearly as much labour to make as others. We believe it is wrong for the manufacturer to dictate the strengths the herbalist should use but prefer to try to accommodate professional herbalists’ experience.