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
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
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