Enabling better medicines by using cGMP Quats as excipients in topical, nasal or ophthalmic applications, Ulla Grove Krogsgaard Thomsen talks about product quality and how to ensure a superior quality control.
In the highly competitive pharma market, quality has become the key differentiator for almost all products and services. Quality control is essential for 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 productivity levels.
With this in mind, we are continuously working on improving our product quality.
Standards have become a symbol for products and service quality, and the majority of customers are now only buying a product or service from a certified manufacturer. Therefore, Novo Nordisk Pharmatech is regularly audited by major and minor pharmaceutical companies and inspected by the Danish Medicine Agency as we are a supplier of EU cGMP manufactured (ICH Q7) quaternary ammonium compounds. We are also complying with and certified according to standards such as ISO 9001 and ISO 14001.
We understand that quality control is a product-oriented process, whereas quality assurance is a process-oriented practice. When it comes to quality control, we make sure that the end product meets the quality requirements, and via quality assurance, we make 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 perceived as a reactive process.
We always strive to develop and provide high-quality products and services that emphasise 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. Therefore, we must incorporate the highest standards across 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.
But a good plan is only as good as its foundation, so comprehensive and detailed product specifications are critical to success. An essential component of product quality is knowing your product and having good process knowledge. In addition, it requires detailed product specifications that identify precisely how the item or items should turn out.
An innovative synthesis process makes Novo Nordisk Pharmatech a leading supplier of cGMP Quaternary Ammonium Compounds (Quats) for a wide range of applications. High purity levels for Benzalkonium Chloride, Cetrimide and Cetrimonium Bromide (CTAB) 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 various solutions, ointments and creams. They can also be used as lysing or precipitating agents in vaccine production.
Our 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 micro-organisms whether they are in a growth phase or not.
Our Benzalkonium Chloride has been tested against several relevant microbial strains and has shown to be effective against a wide range of micro-organisms at low concentrations.
Our production and process knowhow allows us to offer Quats with an entirely 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 Benzalkonium Chloride.
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 future challenges requires vision and direction. We will continue to match and outperform the market as needed.
We do not compromise on quality, which is why our pharmaceutical grade Quats, recombinant Insulin for technical use and enzymes are manufactured following the highest standards; The cGMP Guide ICH Q7 for Active Pharmaceutical Ingredients. Furthermore, we analyse according to relevant multicompendial pharmacopoeias (e.g. Ph.Eur., USP/NF, JP, BP and ChP). Both Novo Nordisk Pharmatech and Novo Nordisk, our parent company and supplier of our Insulin Human AF, are regularly audited by major and minor pharmaceutical companies, the Danish Medicine Agency, and the FDA. Our products are used in many different pharmaceutical and biopharmaceutical drug products approved by regulatory bodies worldwide. For some products, we also supply a complete regulatory package.
We see significant legislative and regulatory changes coming to the industry. In addition, 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. It begins with a consistently high quality of our products, ensuring continuous availability and a secure global supply chain, and ends with 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 help tailor products to enable future therapies.
Our definition of success has not changed; we still want to maintain our position as the market leader and innovator in the industry.
The pharmaceutical industry quality functions are continuously trying to keep up with the rising demands of regulators. In addition, 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, the robustness of processes, and efficiency will, therefore, need to be squared in one equation. That is why we need to be at the very forefront of meeting the industry standards and ensuring patient safety.