1. INTRODUCTION

The manufacturers of pharmaceuticals primarily source their required ingredients, materials, components, and services through external local and global suppliers. External suppliers also provide services such as research and development, manufacturing, assembly, analysis, packaging, warehousing, transportation, and distribution, etc. The expectations on the part of regulatory authorities, healthcare professionals (including medical practitioners, nurses, dentists, and pharmacists), and consumers are that pharmaceutical products will be fitted for their intended use and be of the required quality. This means that active ingredients, excipients, components, other raw materials, and packaging components used in the end product have been manufactured to the appropriate standards and comply with regulations, pharmacopeial monographs, and/or all approved specifications. It also means that the processes in the supply chain for a material or service will also be compliant and do not increase risks to the product.