To explain what exactly it means to have Good Manufacturing Practices (GMP) is to ensure the consistent quality and safety of products by focusing on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures. GMP describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonizing GMP activities at European Union (EU) level. The ICH direction Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredient (API) is intended to provide guidance regarding GMP for the manufacturing of (APIs) under an appropriate system for managing quality. This regulation was finalized under Step 4 in November 2000 and is intended to provide guidance regarding GMP for the manufacturing of APIs under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.