Section Overview

In this chapter, we will learn about recent changes in international guidance documents, specifically new primary EU regulations governing the manufacture of veterinary products and the transitioning of regulations governing the conduct of clinical trials in Europe. Furthermore, we will learn about the FDA's new guidelines relating to cGMP and new final Annexes published in the EU. These changes include stricter labeling requirements for CT material, updated methods and controls to prevent cross-contamination of drugs, and a new concept paper for a future revision to Annex 11 Computerized systems. Additionally, we will learn about introducing the concept of “Contamination Control Strategy” (CCS) and the requirement for a packing list, freight documentation, or customs import declaration to ensure certification only takes place after physical importation and customs clearance.