Insights
How to reduce the risk for your raw materials
1) Get experience and know-how that results in quality products
Quality is not only about meeting increasingly high consumer expectations. Quality also forms the basis of an efficient business that minimizes waste and maximizes productivity.
At Novo Nordisk Pharmatech we are a specialist and dedicated manufacturer of Benzalkonium Chloride products in an unequalled, full cGMP grade. This ensures the quality, purity, and consistency of our raw materials and your final products. We have more than 30 years of experience with cGMP for APIs and 70 years of experience in manufacturing Benzalkonium Chloride (BKC/BAC/BAK/BZK).
2) Partner up with a supplier who works with cGMP
cGMP is embedded in everything we do. We manufacture our pharmaceutical-grade BKC in accordance with the cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients (APIs), the highest available quality standard in the industry. This covers everything from process validation to data integrity and quality metrics to ensure the proper design, monitoring, and control over all manufacturing processes.
This means you get:
- Full traceability.
- High product purity and consistency.
- Full pharmacopeial compliance.
- Audit access.
- Regulatory documentation package.
- Products manufactured under validated processes.
3) Why you should choose pharmaceutical-grade products
By choosing pharmaceutical-grade products, you are ensured the right quality with a high degree of batch-to-batch consistency. It reduces your supply chain risk compared with non-pharma products as you will know the origin of our products and that they meet all the necessary specifications.
Our multi-compendial range of BKC products follows the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some also follow the Japanese Pharmacopoeia (JP) and the Chinese Pharmacopoeia (ChP). This provides you with a global level of compliance to relevant monographs and general chapters.
4) Ensure access to high level of support for quality control testing
Our customers use our BKC products as APIs and excipients, and they can rely on that our validated quality control testing is performed on each manufactured batch. Our stringent Quality Management System ensures that we manufacture products with a high degree of consistency, and we receive excellent ratings in audits from our customers and authorities, including the FDA and Danish Medicines Agency (DMA).
And don’t worry. Our support doesn´t stop as soon as we have shipped your products. We keep all records required by authorities to ensure full traceability from manufacturing to delivery. This means that you will continue to have our support all the way towards the end of your product’s shelf life.
