Scutellaria lateriflora

Our supply of Scutellaria lateriflora or Skullcap Herb growing on a specialist Organic herb farm in North America.  The soil you can see is volcanic ash.  All the water used for irrigation on the farm is melted glacier water - exceptionally pure.

Scutellaria lateriflora is sensitive to the climate and sometimes the crop can fail.

Shortages of Scutellaria lateriflora can lead to price rises as buyers try to outbid each other.

This creates a time of risk for medical herbalists as manufacturers may be tempted to purchase supplies of the raw herb from dubious sources.

Always buy from a GMP licensed company - or insist on a bona fide Certificate of Analysis.

Good Manufacturing Practice

Herbs in a Bottle is a Good Manufacturing Practice (GMP) company.  Our GMP licence is MIA 37212.  You can check whether a company holds a GMP licence by looking at the MHRA Register here:  http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con2030303.pdf

Among herbal medicine manufacturers there are, unfortunately, many weasel words spoken about GMP.

You will often hear "We work to GMP standards" or "We are GMP equivalent" or "What does GMP mean anyway, at the end of the day it's just a paper chase!".

To help dispel some of the misinformation here are some key facts about GMP:

GMP is a quality assurance standard that ensures herbal medicines are consistently manufactured to a pre-determined level of quality.  This means that GMP has two aspects - manufacturing and quality control.  Once a GMP licence has been granted it is enforced through inspections (both scheduled and unannounced) by the Medicines and Healthcare products Regulatory Agency (MHRA).

To gain a GMP licence a company has to follow the Rules and Guidance for Pharmaceutical Manufacturers and Distributors commonly known as the Orange Guide.  By buying from a GMP licensed company medical herbalists are able to state that they are prescribing medicines manufactured to pharmaceutical standards.  We are happy for our customers to state on their websites that they buy their medicines from Herbs in a Bottle and quote our GMP licence number.

The GMP process is, for Herbs in a Bottle, an all-encompassing regime but it can be defined as ten basic rules.

1  All manufacturing procedures are defined in detail in a series of written instructions (SOPs), and training is given on those procedures.

2  The written SOPs must be followed EXACTLY - no cutting corners, no special exceptions.

3  The correct raw materials are defined and specified, and purchased to that specification - if on delivery to Essendine they fail our sampling and testing process they are rejected.

4  The correct equipment must be defined and specified, and training on correct use of equipment (including cleaning regimes) is mandatory.

5  Production staff are trained in all issues around contamination and its prevention.

6  Correct labelling is regarded as crucial to the manufacturing process.

7  Production staff are trained and monitored so that they work accurately and precisely.

8  Production staff are required to follow hygiene and good housekeeping procedures.

9  Above and beyond the formal SOPs all staff must be alert for possible sources of contamination and report anything that might be suspicious.

10  All production staff must keep accurate records of what they have done.

By purchasing your medicines from Herbs in a Bottle you can be sure that you are not prescribing to your patients any toxic or substandard products.  GMP is not a cheap standard to achieve, and means we have to employ more QA and supervisory staff than non-GMP companies, as well as maintaining a higher level of machinery and insisting on higher specifications of raw materials (rejecting substandard herbs can mean we go out of stock for particular items).  Yes, you can get cheaper medicines from other manufacturers - but if they are not GMP licensed the money you save could mean extra risk for your patients.

Our catalogue:  http://herbsinabottle.blogspot.co.uk/2014/04/our-catalogue-is-now-in-searchable-pdf.html

Our website:  www.herbsinabottle.com

Our catalogue is now in a searchable pdf format

The Herbs in a Bottle catalogue is available as a pdf:

Catalogue

It includes a search box, so just type in the name of the herb you are interested in and it will take you straight to the page.

If you want to order just send the product code and amount to sales@herbsinabottle.com and we will process the order and contact you to arrange payment.

Please note that we can only sell to qualified medical herbalists.

Herbs in a Bottle now member of ESSNA

Herbs in a Bottle is pleased to announce that the company has been accepted as a member of ESSNA, the European Specialist Sport Nutrition Alliance.

ESSNA is an association representing the interests of the sport nutrition sector across the European Union.

It was created in 2003 to campaign for appropriate European legislation on sports nutrition products. The association is a respected organisation, widely recognised by legislators and the mainstream media as the voice of the responsible specialist sports nutrition sector in Europe.

ESSNA cooperates actively with the European Institutions and Agencies, national governments, trade bodies, consumer organisations, leading scientists and the media to ensure the fulfilment of its missions.

As a member of ESSNA Herbs in a Bottle with be helping to work towards the following objectives:

• To ensure the development of an appropriate and balanced regulatory framework for sport nutrition products
• To keep abreast of on-going legislative developments to ensure compliance
• To promote reputable sport nutrition brands in the media
• To address the issue of non-compliant products tarnishing the reputation of the sector
• To promote initiatives and campaigns to inform consumers of the benefits of regular physical activity, healthier diets and responsible use of sport nutrition products
• To support continued independent scientific research into sport nutrition and into issues relating to quality and safety

More information:  http://www.essna.com/

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What does our Hygiene policy mean to you...

We take great care over hygiene at the Herbs in a Bottle Essendine site, and everyone who joins the company will go through our Hygiene Training and on-going inspections.

Clothing

Everyone who works in our production areas is required to wear designated overcoats (made of a durable material with no pockets and no button fastenings).  They must also wear hair nets so that hair and ears are completely covered at all times.  The net must be put on before the coat to avoid any hairs getting onto the coats.

Only work shoes can be used in production areas, and outdoor shoes must be left in the locker room.

No watches or jewellery are allowed (with the exception of plain gold wedding bands).  Wearing nail varnish, strong perfume or excessive make-up is not permitted.  Mobile 'phones and other personal electronic equipment cannot be taken into the production areas.

At the start of each shift all production personnel are inspected by their managers.

All staff are reminded that raw materials, intermediate or finished products must not come into contact with bare hands.

Food and Drink

Drinking water is provided at a specific point in the Despatch office.  Otherwise no food or drink is allowed in the production areas.  A staff canteen (outside the production areas) is provided where staff can take their breaks.

Smoking

Herbs in a Bottle Essendine is a no-smoking site.

Personal Hygiene

All production personnel are required to wash their arms and hands thoroughly before commencing work and regularly throughout the day as required (and always after toilet visits).  Washing arms and hands between product batches is mandatory.  Fingernails must be kept short and clean.

Exposed cuts and abrasions must be covered with blue detectable waterproof dressings.

Health declaration forms must be completed by all production staff returning to work after an absence (including holidays abroad), after sickness and after any unauthorised absence.

Stomach upsets developing on-shift must be reported immediately to a supervisor.  All personnel suffering from or coming onto contact with infections (eg typhoid, dysentery, staphylococcal infection) must immediately inform the management team, and where necessary health clearance from their doctor will be required before they can return to work.  No personal medications are allowed in the production areas.

Visitors

All visitors to the Essendine site are recorded and must complete a health questionnaire.  Visitors cannot enter production areas without authorisation, and must comply with the rules on wearing protective clothing including shoe coverings.  Hand wash rules also apply.

Miscellaneous requirements

There are many other hygiene procedures in force throughout Essendine, and these vary according to the equipment operated and the way the respective herbs are processed.  For instance, disposable aprons and gloves are worn for processing powders and dry herbs; special green coats must be worn in the mill room; spillages must never be returned to clean stock etc.

What does our Hygiene policy mean to you...

The high standards we insist upon through our Hygiene policy mean that our products are clean and uncontaminated.  We always keep in mind the fact that ultimately our medicines will be prescribed to people who are ill and often will have low immunity.  Cleanliness and hygiene is not just good business, it is a moral duty to those end users we seek to serve.

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Ensuring harmful foreign matter does not enter herbal medicine production

It goes without saying that herbal medicines should not contain poisonous, dangerous or otherwise harmful foreign matter or residue.

At Herbs in a Bottle we work hard to ensure the raw herbs we use are entirely free from contamination by moulds, insects, and other animal contamination including animal excreta.  The first check we do is visual, looking for abnormal odours, discolouration, slime or signs of deterioration.  Soil, sand, stones and dust are also looked for.

During storage we take special care to avoid formation of moulds since they may produce aflatoxins.

As well as macroscopical examination (looking at the shape, size, colour, surface characteristics, texture, fracture and appearance) we also use microscopy (HPTLC) which provides most of the information we require on the identity, purity and often the quality of the raw herbs.

Additionally we will test for loss on drying (which determines water and volatile matter), and we will carry out ash tests (both total ash and acid-insoluble ash).

Tests are carried out to determine the volatile oils.

Tests are carried out to determine the swelling index (the volume in millilitres taken up by the swelling of one gram of herb under specified conditions).

We strongly encourage our customers to visit Essendine and see our sampling and testing regime - it will give you complete peace of mind that the medicines you are prescribing for your patients are safe and uncontaminated.

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The importance of sampling

The only way to ensure the purity and integrity of herbal medicine production is through eternal vigilance.  This must include a stringent and rigorous sampling regime.  Only through comprehensive sampling can control over quality be maintained.

When you purchase herbal medicines do not accept bland assurances that samples have been taken of the raw herbs.  A sample is only reliable if represents the whole batch.  Here is a brief overview of the Herbs in a Bottle sampling procedure:

All deliveries of raw herbs are sampled, with samples taken from the upper (not less than 10cm from the top), middle and lower parts of a container or package.  Samples of seeds are withdrawn with a grain probe.   In mass samples must be as uniform as possible.

The average sample is quartered - dividing it diagonally into four equal parts.  Two opposite parts are carefully mixed, and the process repeated until the required quantity is obtained for the testing to be carried out.  A portion of the final sample is retained to act as a reference.

Tests are carried out on the following:

• Organoleptic characteristics (colour, texture, odour)
• Presentation of material (raw, crushed, cut compressed)
• Presence of admixtures, foreign matter (sand, glass, particles, dirt), mould or signs of decay
• Presence of insects
• Presence of packaging material originating from poor or degraded containers

If the sample fails the tests the batch cannot be used in production.

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Allergen management and control

When you buy herbal medicines, do you know what your supplier's policies and procedures are towards towards allergens?  Do they even have policies and procedures?  Or are they just putting different raw materials through production and hoping for the best?

At Herbs in a Bottle we recognise the potential risk to human health from materials derived from sources classified as potentially allergenous.  Strict rules of cross-contamination control (based on HACCP) are in place.  As a GMP company we take very seriously the implementation and auditing of allergen management and control.

The following are considered potential allergens:

• Peanuts
• Nuts - including almonds, hazelnuts, walnuts, pecans, Brazil nuts, macadamia nuts, cashew nuts, pistachio nuts, Queensland nuts
• Eggs
• Milk
• Crustaceans
• Sesame seed
• Fish
• Soya
• Celery
• Mustard
• Sulphur dioxide and sulphites
• Lupin
• Molluscs
• Cereals containing gluten (wheat, rye, barley, oat, spelt, kamut)

All our suppliers are required to have nut and allergen control strategies in place and provide appropriate documentation providing traceability of raw material batches.

If allergens are allowed into Essendine they must go into designated storage locations for potential allergens and undergo risk assessment on the source and composition of the material.  The raw materials will be labelled with "Potential allergen" warnings and stored in sealed packaging.  The stocks are controlled in production and reconciled after production.

Great stress is placed on avoiding any cross-contamination.  Procedures include comprehensive staff training, documented cleaning procedures, application of validated cleaning methods and pharmaceutical-standard positive/negative air balance in the production rooms.  A designated supervisor will assess production rooms, equipment and personnel prior to and throughout manufacturing.

Rooms have prohibited entry status before and during manufacture and during the comprehensive end clean down.

After manufacture all containers are sealed, decontaminated on the exterior, and removed.

Our QC department routinely takes samples from the final cleaning rinse to ensure no possibility of cros-contamination - these samples undergo HPTLC analysis.

When you buy Herbs in a Bottle medicines you can be sure that your patients will not be adversely affected by cross contamination with allergens.

Inula helenium root

Today we are making products from raw Inula helenium root - cut herb, powder, fluid extract and tincture.

As with all raw herbs entering Essendine, the roots will go through many tests before they are released for production including formal identification; formal check on status (GMO herbs are not allowed onto our Essendine site, and all herbs must have documented proof that they are GMO free); microbiological analysis (including checks for TVC, enterobacteriacea, yeast & moulds, E-coli, Salmonella, Staphylococcus Aureus); checks for toxins (including lead, cadmium, mercury and arsenic); checks for pesticide residues, checks for aflotoxins etc

If for any reason the raw herb fails the tests it is rejected - there is no possibility it can be released for production, no matter how urgent the demand might be.

Calendula

Calendula is one of the most versatile plants in our Materia Medica and deserves special attention.

We obtain the finest Calendula flowers from each new crop and carefully check all aspects of quality, including a full pesticide residue analysis.

Our extracts are carefully percolated without the use of additional heat.