ARTICLES BY HAL CRAIG

• Individual Or Pooled cGMP Audits — How To Choose The Right Format

  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.

• Supply Agreements — Removing The Stress From 'Failure To Supply' Negotiations

  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.

• Supply Agreements — Does The 'Failure To Supply' Provision Have To Be So Difficult To Negotiate?

  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.