ARTICLES BY HAL CRAIG

• 5 Supply Chain Questions Every Drug Company Should Know The Answers To

  Part 1 of this two-part column raised the point that if you’re not happy with one or more of your suppliers, it may be because you haven’t clearly told them what you want, what your expectations are, and what is important to you. Here in Part 2, we explore five important questions that can serve as a brief checklist to help drug companies both figure out and communicate their expectations to suppliers and understand their suppliers’ expectations.

• They’re Not Mind Readers: Have You Told Your Suppliers What You Want?

  There are many reasons for issues to crop up in a supply chain. For some, there aren’t realistic, economical work-arounds available to every company to mitigate all consequences.

• 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.