NOVO NORDISK PHARMATECH AS

ENSURING QUALITY ASSURANCE

Rasmus Hother le Fevre, Managing Director Corporate Vice President Novo Nordisk Pharmatech AS

Ensuring quality in formulation The benefits of using GMP Quats as excipients in topical nasal andor ophthalmic applications Managing Director CVPRasmus Hother le Fevre Novo Nordisk Pharmatech AS talks about the industry challenges on product quality and how to ensure a good quality control

Can you explain the role of formal documentation in quality assurance?

In this highly competitive market, quality has become the market differentiator for almost all products and services. Quality control
is essential to building a successful business that delivers products that meet or exceed customers’ expectations. It also forms the basis of an efficient business that minimises waste and operates at high levels of productivity.

Therefore, we are constantly working on enhancing our product quality.

Since standards have become a symbol for products and service quality, customers are now keen on buying a product or service from a certified manufacturer. Therefore, Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency. We are also complying with and certified according to standards such as ISO 9001 and ISO 14001.

When it comes to our focus, we understand that quality control is a product-oriented process. When it comes to quality assurance, it is a process-oriented practice. When quality control makes sure the end product meets the quality requirements, quality assurance makes sure that the process of manufacturing the product does adhere to standards. Therefore, quality assurance can be identified as a proactive process, while quality control can be noted as a reactive process.

Besides quality monitoring, what else can you suggest to ensure quality of materials and products?

We always strive to develop and provide high quality products and services that place emphasis on the health and safety of our consumers and customers.

With more than 70 years of experience, we want to ensure that the products reaching our customers meet the highest levels of quality and safety. We must incorporate the highest possible standards all along the supply chain – from raw materials, to manufacturing, packaging and distribution.

Controlling quality by utilising product inspections throughout the production cycle reduces sourcing risks and cost and ensures high quality.

A good plan is only as good as its foundation, so comprehensive and detailed product specifications are critical to success. An important component of product quality is knowing your product. And, that requires detailed product specifications that identifying exactly how the item(s) should turn out.

Can you explain the benefits of using GMP Quats as excipients in topical, nasal and/or ophthalmic applications?

An innovative synthesis process makes Novo Nordisk Pharmatech a leading supplier of cGMP Quaternary Ammonium Compounds (Quats) for a wide range of applications. High levels of purity for products such as Benzalkonium Chloride, Cetrimide, Cetrimonium Bromide (CTAB) and a range of others make them particularly suited for pharmaceutical applications. They act either as preservatives or active ingredients in many ophthalmic, nasal, oral and topical drugs and in a variety of solutions, ointments and creams. They can also be used as lysing or precipitating agents in vaccine production.

FeF™ Quats are effective at all pH levels. However, their effectiveness increases when the pH increases. The higher the pH, the lower the concentration needed to obtain an antimicrobial effect. As opposed to bacteriostatic/fungistatic compounds which only prevent micro-organisms from dividing (growing), Quats are bactericidal/fungicidal meaning they will kill microorganisms whether they are in a growth phase or not.

FeF™ BKC has been tested against several relevant microbial strains and shown to be effective against a wide range of microorganisms at low concentrations.

Our production and process know-how allows us to offer Quats with a completely well-defined alkyl chain length distribution, whether it is with our standard chain length or with customised chain length distributions. Our customers also receive a regulatory package, which will help the approval process of their product when using FeF™ BKC.

How does Novo Nordisk Pharmatech ensure to stay on top of the pace of technology change?

We have a clear vision and strategy to develop the business over the coming years. Our customers see us as the market leader and innovator in the industry, and to meet the coming challenges requires vision and direction. We will continue to match and outperform the market as required.

How does Novo Nordisk Pharmatech ensure that industry standards are met, if not exceeded?

We do not compromise on quality, which is why our pharmaceutical Quats and recombinant Insulin Human are manufactured in accordance with the highest standards- the cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients. We analyse according to relevant multicompendial pharmacopoeias (e.g. Ph.Eur., USP/NF, JP and BP). Both Novo Nordisk and Novo Nordisk Pharmatech are regularly audited by major and minor pharmaceutical companies, the Danish Medicine Agency as well as the FDA. Our products are used in many different pharmaceutical and biopharmaceutical drug products approved by regulatory bodies worldwide and for some products we also supply a full regulatory package.

What are the biggest challenges currently facing the pharmaceutical/healthcare markets and how does Novo Nordisk Pharmatech tackle them?

Big legislative and regulatory changes are coming to the industry. There is an increase in regulatory expectations from Innovators and Generics to be able to guarantee patient safety due to today’s expanding global market.

We aim to be the best supplier of pharmaceutical ingredients by providing excellence at every step of the supply chain – beginning with a consistent high quality of our products, ensuring continuous availability and a secure global supply chain, to an extensive regulatory documentation living up to the highest available standards.

By delivering excellence at every step, we help our customers do the same – whether they’re developing a cure for cancer or a new ophthalmic. We deliver a proven record of product purity, reliability and consistency and can even tailor products for future therapies. We help keep development on track and production flowing for hospitals and patients.

How has your definition of success changed over the year? Where do you think the industry is headed?

Our definition of success has not changed; we still want to maintain the position of market leader and innovator in the industry.

The pharmaceutical industry quality functions are struggling to keep up with the rising demands of regulators. The increasing relevance of global markets (beyond the United States, European Union, and Japan) is adding the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency will need to be squared in one equation. That is the reason why we need to be at the very forefront when it comes to meeting the industry standards and ensuring patient safety.

--Issue 36--

Author Bio

Rasmus Hother le Fevre

Hother le Fevre started as a Production Planner in Novo Nordisk A/S in 2000. In 2003 he became the head of Shipping and Customer Service and in 2004 he took up the role as Director for the purification plant responsible of purification of Insulin Levemir and Insulin Aspart. In 2006 he became Corporate Vice President heading up the purification plants and in 2010 relocated to Zürich as Global Marketing Director head of Victoza® Launch Execution Team. In 2012 he became the Managing director & Corporate Vice President at Novo Nordisk Pharmatech A/S.

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