We have gathered four important considerations on how to reduce the risk for your raw materials and get peace of mind for your full product life cycle.
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 Quats products (Benzalkonium Chloride, CTAB, and Cetrimide) in an unequalled, full cGMP grade. This ensures the quality, purity, and consistency of raw materials and final products. We have more than 30 years of experience with cGMP and 70 years of experience in manufacturing Benzalkonium Chloride.
cGMP is embedded in everything we do. We manufacture our pharmaceutical-grade products 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.
• Full USP/NF compliance.
• Audit access.
• Full regulatory documentation package.
• Products manufactured under fully validated processes.
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 manufacturers of multiple products or APIs as you will know the origin of our products and that they meet all the necessary specifications.
Our multi-compendial range of products follow the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some Quats products also follow the Japanese Pharmacopoeia (JP), the British Pharmacopoeia (BP) or the Chinese Pharmacopoeia (ChP). You, therefore, have complete assurance that products will meet regulatory guidelines.
Knowing that many of our customers use our Quats as APIs and excipients, we provide a very high level of support for quality control testing. Our stringent Quality Management System ensures the right quality products with a high degree of consistency, and we receive excellent ratings in audits from our customers and authorities, including the FDA and EMA.
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 towards the end of your product’s shelf life – or even after.