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:
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.
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.
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