On-site cGMP audits are an important part of creating and maintaining a compliant, reliable, and secure supply chain that safely provides high-quality clinical and commercial drug products when and where needed. An important auditing decision is whether to use an individual or pooled audit.
The failure to supply (FtS) provision in a drug product or drug substance supply agreement can be the most hard fought over “what if” in the agreement and, after price and volume, the section of an agreement with a high potential to fracture a customer-supplier relationship.
The failure to supply provision in a drug product or drug substance supply agreement can be the most hard fought-over “what if” in the agreement and has the potential to fracture a customer-supplier relationship.