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Pharma Tech Outlook | Wednesday, October 04, 2023
Supplier Quality Management in pharmaceuticals ensures external supplies meet the regulated standards for pharmaceutical products.
FREMONT, CA: In the ever-evolving landscape of pharmaceuticals, the supplier quality management (SQM) process stands as a formidable pillar, ensuring that the raw materials, components, and services sourced from external suppliers align seamlessly with the industry's stringent quality standards. This process serves as the bedrock upon which safety, efficacy, and regulatory compliance are built while simultaneously driving cost-efficiency and eradicating the inherent risks and inefficiencies. SQM ensures that external suppliers' raw materials, components, and services meet the quality standards and specifications of the pharmaceutical industry. However, the evolving transitions in recent years towards a digitisation-driven trend are favouring a more dynamic and complex pharma environment.
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One such factor that is upscaling the supplier quality management practice is evolving regulatory requirements and expectations from varied authorities all around Europe. These guidelines impose strict and acute divergent rules and standards for the quality, safety, and traceability of pharmaceutical products and their ingredients. For instance, the EU Falsified Medicines Directive (FMD) requires serialisation and verification of product units individually. Pharma companies ought to critically ensure that suppliers follow these guidelines and provide the necessary documentation and data for achieving compliance with these regulations. It also includes collaboration and communication between the parties, robust systems, and tools for auditing, monitoring, and reporting.
Similarly, increased globalisation and outsourcing of the pharma supply chain are also enhancing the supply quality management system in the pharmaceutical space. That is, pharma companies outsource their materials and services from different regions offering lower costs, higher capacities, and specialised expertise. It critically exposes enterprises to greater variabilities, uncertainties, and risks concerning quality, reliability, and security.
For instance, the pandemic scenario has disrupted the global supply chain and highlighted the vulnerability of pharma companies, highlighting delays, quality issues, and critical inputs. Hence, pharma companies are aiming to diversify their supplier base, establish contingency plans, and implement rigorous quality control and assurance measures all across the supply chain to effectively mitigate these risk factors.
Innovation and complexity of pharma products and processes are furthermore influencing the SQM in the pharmaceutical space. Companies in the domain are constantly developing new and improved products like biologics, biosimilars, gene therapies, and personalised medicines, requiring more advanced and specialised materials and technologies.
However, these products may be regarded as highly sensitive, variable, and difficult to characterise and validate, causing quality-based challenges. This critically highlights the need for quality assurance in the pharmaceutical space, especially with businesses in the pharma space opting for complex and agile processes like continuous manufacturing, digitisation, and automation. These measures require increased integration and coordination of the supplier network.
Pharma companies are increasingly fostering innovations and collaborations with their suppliers, leveraging data analytics for quality improvement and decision-making on an increased scale to adopt an efficient risk-based and supply quality management approach.
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