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Global regulatory compliance
Our pharmaceutical Quats and recombinant Insulin Human are manufactured in accordance with cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients, the highest available standard. We analyse according to relevant multicompendial pharmacopoeias (eg. Ph.Eur., USP/NF, JP and BP). Our pharmaceutical Quats are used in many different products and our recombinant Insulin Human AF is used in the manufacturing of several biopharmaceutical drug products approved by regulatory bodies worldwide.
Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency.
Our comprehensive documentation and services include:
- ISO 9001 Certificate
- GMP Certificate from the Danish Medicine Agency
- Certificate of Analysis (current version of pharmacopoeias)
- Customer audits
- Declarations, statements (stability, residual solvents, TSE/BSE, GMO, allergens, elemental impurities, etc.)
- Change Notification
- Answering of questionnaires
- Process flowchart
- Packaging details
- Enter quality assurance agreements on Novo Nordisk Pharmatech template
Quality management system
Novo Nordisk Pharmatech’s quality management system is in compliance with DS/EN ISO 9001 in all of our activities and includes production, QA/QC, sales and marketing, R&D, shipping information and customer services. The high quality of our products is ensured by our efficient quality assurance systems and quality control carried out by highly experienced professionals.
Environment and safety
Environmental considerations are an integral part of our everyday work. Our main concerns include reducing atmospheric emissions of organic solvents from the production process, and carbon dioxide and nitrogen oxide from the production of energy. We have implemented an Environmental Policy and are DS/EN ISO 14001 as well as OHSAS 18001 certified.
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REACH at Novo Nordisk Pharmatech
All relevant products manufactured at Novo Nordisk Pharmatech were pre-registered with ECHA in 2008. Insulin Human products were pre-registered by Novo Nordisk. Our FeF Cetrimide™ and FeF CTAB™ products were registered in 2013. See our pre-registration / registration numbers and registration deadlines here. The registration deadline for FeF Benzalkonium Chloride™ products is May 2018.
We are involved in the relevant SIEF groups, either as a Lead Registrant or as an active participant. Both our internal specialists as well as external consultants will insure that our products are registered in due time. A continuous dialogue with our suppliers and customers will help guarantee a smooth progression of the registration process.