Global cGMP manufacturing: regional production enhances supply chain logistics

Raw material suppliers help to strengthen global supply chains with cGMP production in new regions

Devashish Ohri, Executive Vice President, APAC, Avantor

State-of-the-art current good manufacturing practices (cGMPs) are being implemented globally to ensure the safe manufacture, testing and quality assurance of pharmaceutical and biopharmaceutical products.

Companies using cGMP procedures do so to satisfy evolving regulatory guidelines and processes, enabling them to meet strict requirements for product consistency, reproducibility and traceability of all the materials used in finished drug production.

This move in cGMP manufacturing is driven in part by the need to meet the healthcare demands of fast-growing global markets. As the majority of the world’s population — approximately 80% — lives in regions outside of Europe and North America, the desire to cost-effectively provide high quality drugs to these markets is leading pharmaceutical companies to set up operations closer to their patients.

For drug manufacturers pursuing these emerging markets, it is essential that they secure well-characterised raw materials that consistently meet quality standards from lot to lot to safeguard their global supply chains. In response to this trend, raw material suppliers are expanding their production and supply chain footprints to key regions around the globe.

However, expanding global production is only the beginning. Key to success is investing in a full range of cGMP practices and processes outside of North America and Europe to satisfy, and in many cases exceed, multicompendial regulatory requirements. These investments, by both raw material suppliers and drug manufacturers, represent an important change: it’s not about having a local plant for local markets, it’s about having global plants in key regions — cGMP plants engineered and operated to the highest standards of quality.

As an example, Avantor recently began to operate a new cGMP production line for high-purity, low-endotoxin sugars at its plant in Panoli, India. Commonly used in biopharmaceutical parenteral drug manufacturing, these sugars are produced in India using the same cGMP systems used in Avantor’s US facility. This is unique in that the product meets cGMP standards … regardless of where it is made.

Having cGMP production capabilities close to pharmaceutical and biopharmaceutical manufacturers is crucial; but, to fully leverage the value of global cGMP supply chains, suppliers and manufacturers must establish strong collaborative relationships. Manufacturers value suppliers that can do more than simply deliver characterised products; they want suppliers that can provide expertise into how best to use those products.

There are significant benefits to collaborating with raw material suppliers that offer expertise in research and development, chemistry, biochemistry and material science, as well as dedicated laboratories. These suppliers can work closely with customers to uncover their unique biopharmaceutical challenges and develop tailored solutions to improve formulation quality, purity and process yields, or to reduce operational costs.

This level of global support also helps manufacturers to develop products that comply with regional regulations, and allows them to respond to regulatory enquiries about materials used in their drug manufacturing process, no matter where the materials originated.

Manufacturers and suppliers both realise strategic advantages in developing global cGMP production sites and supply chains. Drug companies can confidently expand into new markets with the security of knowing that materials meeting the highest regulatory specifications are readily available; and suppliers can quickly and effectively respond to supply chain requirements from global-scale pharmaceutical and biopharmaceutical customers. Securing well-characterised raw materials that consistently meet quality standards from lot to lot is essential to safeguarding global supply chains.

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