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Pharmaceutical Manufacturing and Packing Sourcer
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The biopharmaceutical manufacturing sector is adopting new technologies and consumables at a fast pace to meet growth demands and increase flexibility. At the same time, regulatory authorities are putting pressure on biomanufacturers to have control over their full supply chains. Indeed, both manufacturers and industry working groups are placing increased emphasis on raw material and supplier management to help protect patients, enhance transparency and minimise risk (1-4). Additional concerns centre around events that might interrupt the supply of components needed to manufacture human health products.
Some suppliers are responding by investing in strategies, in-house expertise and human and system resources to help biomanufacturers meet these needs, but others are not as responsive. When choosing suppliers, a structured and risk-based approach is important.
A Holistic Approach
Ensuring that materials are available when needed is a key aspect of a supply chain security programme, but it is not sufficient for suppliers to focus on this alone. The products must maintain a high level of quality each time, and any changes must be communicated in a punctual and transparent manner. A comprehensive supply security strategy addresses these needs. One example of a holistic approach is based on three interrelated concepts (see Figure 1).
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