HACCP certification is an international standard defining the requirements for effective control of food safety. It is built around seven principles:

• Conduct Hazard Analysis of biological, chemical or physical food hazards
• Determine critical control points
• Establish critical control limits
• Establish a system to monitor control of Critical Control Points
• Establish corrective actions
• Establish procedure for verification to confirm that the HACCP system is working effectively
• Establish documentation and record keeping

Good manufacturing practice (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 harmonising GMP activities at European Union (EU) level. Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP.

GMP requires that medicines:

• Are of consistent high quality;
• Are appropriate for their intended use;
• Meet the requirements of the marketing authorisation or clinical trial authorisation.