By Novo Nordisk…
Novo Nordisk Pharmatech re-engineers supply chain for ‘full peace of mind’
Koege, Denmark: – World-leading cGMP Human Insulin AF and quaternary ammonium compounds (Quats) specialist Novo Nordisk Pharmatech A/S has strengthened every aspect of its supply chain to help pharmaceutical and biopharma companies challenged by the COVID-19 novel coronavirus pandemic and ever-tighter regulatory requirements.
Novo Nordisk Pharmatech has aimed to enable customers to reduce their material risks, with high levels of consistency in both the quality and supply of its Quats and Human Insulin AF, along with comprehensive documentation package and tailored support, continuing through the whole product life cycle.
The full strength of the Novo Nordisk supply chain is described in a recently authored article, available for download (see Resources).
Eliminating quality risks
To eliminate upstream materials risks, Novo Nordisk Pharmatech pays the utmost attention to raw materials and manufacturing quality across its range of Insulin Human AF and pharma-grade Quats, for use as both APIs and excipients, producing these to unequalled, full cGMP grade.
The company has further strengthened its stringent Quality Management System to ensure absolute product quality and consistency, achieving excellent ratings in audits from customers and authorities, including the FDA and EMA. Its multi-compendial Quats range complies with highest regulatory guideline standards, including ICH Q7, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP). Some of its Quats also align with the Japanese Pharmacopoeia (JP) or British Pharmacopoeia (BP).
Ultra-high quality Insulin Human AF is manufactured by parent company, Novo Nordisk, which has been a leading insulin supplier for a century. Animal-free human insulin eliminates risk of impurities such as mycoplasmas that can pass from upstream bioreactor to contaminate a whole product line. Novo Nordisk manufactures its Insulin Human AF in cGMP facilities, following an ISO 9001 quality system.
Since insulin can only be produced in infrequent manufacturing batches a year, the large scale of Novo Nordisk manufacture and its highly standardized processes are vital to ensure product availability and consistency. The insulin is analyzed according to the current European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopoeia (USP).
Whole life cycle support
All customers need high levels of after sales support and documentation. Novo Nordisk Pharmatech meets these needs with such measures as very high level of support for quality control testing, providing extensive and detailed information about its quality testing methodologies, which often out-perform monograph methodology. This allows customers to replicate these methodologies in their own labs to reconfirm raw materials are compliant with certificate of analysis.
To help customers decide what testing they need to do for each process, Novo Nordisk Pharmatech supplies supporting risk assessment documentation to meet demands such as those of ICH Q3D guidelines for a defined control strategy for elemental impurities. This extensive documentation can save customers the expense of running additional tests.
To support the entire product life cycle, Novo Nordisk Pharmatech retains all records required by authorities to ensure full traceability from manufacturing to delivery, enabling documentary and audit support to be maintained past the end of product shelf life.
Robust supply chain
To ensure rapid response to authority audits, Novo Nordisk Pharmatech enters into direct agreements with end-user customers to provide them with direct access to data and ensure traceability across the whole supply chain.
Novo Nordisk Pharmatech is also aware that supply chain stability is also determined by financial, sociopolitical and environmental factors.
The company operates to a Triple Bottom Line principle in which social investment is seen as ensuring long-term sustainability and profitability. This is supported by its basing in Denmark, which provides very stable political and civil conditions and by being part of Novo Nordisk, one of the world’s longest established and most financially stable pharma companies.
Examples of the Triple Bottom Line in action included providing direct assistance to the Danish Government during the coronavirus crisis and issuing rebates to ensure that people around the world still received their insulin.
About Novo Nordisk Pharmatech A/S
Novo Nordisk Pharmatech A/S was established in 1949, acquired by Novo Nordisk in 1986 and has been part of the pharmaceutical group since then.
Novo Nordisk Pharmatech A/S is the leading worldwide supplier of Recombinant Insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds (Quats) for the pharma and biopharmaceutical industries.
Click on Get peace of mind for your full product life cycle to download the full article.