With state-of-the-art technology emerging in the life sciences industry, regulatory requirements continue to become more strict. It’s vital that companies manage their manufacturing processes in accordance with their surrounding governing agencies. Supplier management is a key factor that will help life science companies achieve good manufacturing practices (GMP).

For example, the Food and Drug Administration (FDA) is concerned with processes involved in making a product, but holds only the manufacturer responsible. Suppliers are not scrutinized by the FDA but will be held accountable as part of the manufacturers’ quality management system (QMS). Companies have developed complex and intricate supply chains to attain business needs, and having a quality supplier management system in place is vital for establishing firm GMP. The FDA Code of Federal Regulations (CFR) Title 21 Part 820 provides guidance for managing the processes of purchasing product and services.

Supplier management consists of five key elements:
1. Planning
2. Selection
3. Evaluation and acceptance
4. Controls and responsibilities
5. Delivery and monitoring

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