Pharmaceutical manufacturing is a sector where the role of supplier management is critical. It directly affects every aspect of product quality, safety and regulatory compliance. To comply with the regulations, pharmaceutical companies must have a strongly defined supplier management process in place that helps to ensure all their suppliers meet the necessary quality standards.
The following article includes five) of several necessary requirements a pharmaceutical company should enforce upon their suppliers.
Supplier Qualification
It is incumbent upon pharmaceutical companies to develop a robust supplier qualification process to assess and qualify new suppliers prior to utilizing them. This includes confirming that the supplier has adequate Quality Systems, reviewing their manufacturing process and conducting a risk assessment of what could be quality or safety problems.
Ongoing Supplier Performance
Oversight Pharmaceutical companies are required to have strong oversight measures once a supplier has been approved to maintain high quality standards throughout performance. This will involve periodic audits of their facilities and quality systems, reviewing their manufacturing and testing records, and monitoring any quality or safety issues.
Quality Agreements
Quality agreements are written contracts outlining each party’s (supplier and pharmaceutical company) responsibilities for ensuring product quality and regulatory compliance. These agreements might touch on specifications, testing methods, change control and/or corrective action processes.
Risk Management
Pharmaceutical companies must develop a risk-based supplier management program to identify and evaluate the different risks associated with each supplier, enabling them to identify a risk mitigation strategy. Determine most important suppliers and create alternative plans if supply chain stability is ever challenged.
Collaboration and teamwork are needed throughout every sector of the agency.
Using Gartner’s report as a wake-up call, pharmaceutical companies now need to ensure that they employ the right communication and collaboration methods for identifying quality and safety incidents with their suppliers. This includes setting a level of expectations and requirements with suppliers, sharing quality information/safety data as appropriate, and working together to create continuous improvement plans.
To sum up, the essence of pharmaceutical manufacturing is supplier management which needs a comprehensive and systematic approach to deliver high-quality safe drugs in compliance with regulations. The following essential elements can help pharma manufacturers to keep their supplier management function robust and non-breaking in nature, alleviating risks in supply chains.
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