96% GMP Pharmaceutical Ethanol
Cargill’s 96% GMP Pharma Ethanol is a superior quality product that conforms to the European Pharmacopeia and is produced in The Netherlands in compliance with GMP for medicines and active substances under EU Regulation No. 1252/2014 and Directive 2003/94/EC. The production line is registered with the Dutch pharmaceutical authority. The 96% GMP Pharma Ethanol offers numerous benefits and contributes to the high quality of your final product.
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.*
* Source: World Health Organisation - http://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/
GMP covers all aspects of production:
Our GMP Quality Commitment
Detailed, written procedures
To provide you with documented proof of consistent processes, whether for your own records or audits
Batch production and release
To provide 100% traceability and transparency
4-eye control system
To ensure quality at all stages of production
Certificate of analyses with measured results
To save you valuable time and adminstration
GMP approved transport
To ensure safe, reliable transportation
Common Applications
Excise
Alcohol is subject to excise duty. National authorities consequently stringently control all shipments of alcohol. The excise rates in the EU vary among the different member states and can amount to as much as 40 times the sales price. It is therefore imperative to adhere to the regulations in the EU member states in which we operate. Our alcohol can be delivered pure, without any additional products. In this case, consignees must have a license from their national authorities to receive ethyl alcohol under suspension of duty. Denatured alcohol can be exempt of duty, provided the national authorities accept the added product as a denaturant. We reiterate that the different EU member states each have their own policy regarding accepting these products. It depends on the national legislation if a specific license is necessary and under which conditions a consignee may receive the alcohol.
For more information please review the general European regulations regarding excise and check with your local excise authorities.