SECTION 1. INTRODUCTION AND SCOPE

Excipients are used in virtually all drug products and are essential to product performance and quality. Typically, excipients are manufactured and supplied so that they comply with compendial standards. The pharmaceutical excipient supply chain participants include manufacturers, distributors, brokers, suppliers, traders, transporters, forwarding agents, and repackagers. The quality of pharmaceutical excipients is affected by inadequate control of activities including distribution, packaging, repackaging, labeling, and storage. Improper or inadequately controlled trade and distribution practices can pose a significant risk to the quality of pharmaceutical excipients and can increase the risk of contamination, cross-contamination, adulteration, mix-ups, degradation, or changes in physical or chemical properties. To maintain the original and intended quality, all participants in the excipient supply chain should carry out their activities according to appropriate standards for good trade and distribution practices as discussed in this chapter.