What are the current trends and challenges in supplier quality management in pharma?

1 Regulatory changes

One of the main drivers of SQM is the constant evolution of regulatory requirements and expectations from various authorities, such as the FDA, EMA, MHRA, and others. These authorities impose strict and often divergent rules and standards for quality, safety, and traceability of pharmaceutical products and their ingredients. For example, the EU Falsified Medicines Directive (FMD) requires serialization and verification of each product unit, while the US Drug Supply Chain Security Act (DSCSA) mandates electronic tracking and reporting of product transactions. To comply with these regulations, pharma companies need to ensure that their suppliers follow the same guidelines and provide the necessary documentation and data. This requires close collaboration and communication between the parties, as well as robust systems and tools for auditing, monitoring, and reporting.

2 Globalization and outsourcing

Another trend that affects SQM is the increasing globalization and outsourcing of the pharma supply chain. Pharma companies often source their materials and services from different countries and regions, which offer lower costs, higher capacities, and specialized expertise. However, this also exposes them to greater variability, uncertainty, and risk in terms of quality, reliability, and security. For instance, the COVID-19 pandemic has disrupted the global supply chain and highlighted the vulnerability of pharma companies to shortages, delays, and quality issues of critical inputs. To mitigate these risks, pharma companies need to diversify their supplier base, establish contingency plans, and implement rigorous quality control and assurance measures across the supply chain.

4 Customer expectations

A fourth factor that impacts SQM is the customer expectations and demands for quality, transparency, and sustainability. Customers, such as patients, healthcare providers, payers, and regulators, expect pharma products to be safe, effective, consistent, and affordable. They also want to know more about the origin, composition, and performance of the products, as well as the environmental and social impact of the production and distribution. To meet these expectations, pharma companies need to ensure that their suppliers adhere to the highest quality standards and practices, as well as disclose and demonstrate their quality performance and credentials. This requires a culture of quality excellence and accountability throughout the supply chain, as well as effective communication and engagement with the customers.

5 Skills and competencies

A fifth factor that affects SQM is the skills and competencies of the people involved in the process. SQM is a multidisciplinary and cross-functional activity that requires a range of technical, managerial, and interpersonal skills. These skills include quality engineering, auditing, risk management, problem solving, data analysis, project management, negotiation, communication, and teamwork. However, these skills are often scarce, outdated, or mismatched in the pharma industry, as well as in the supplier network. This creates gaps and inefficiencies in the SQM process, as well as potential errors and conflicts. To overcome these gaps, pharma companies need to invest in training and development of their own staff, as well as their suppliers, to enhance their quality capabilities and competencies. They also need to foster a culture of learning and sharing of best practices across the supply chain.