ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 5.1: Design, build, identify and use process equipment so it suits its purpose, does not alter product, stays within its qualified range and has current drawings

What does 5.1 require?

Process equipment should be properly designed, adequately sized and placed for its use, cleaning, sanitisation where relevant and maintenance. Product-contact surfaces should not change the quality of intermediates or APIs beyond their specifications. Equipment should only be run inside its qualified operating range. Major equipment and fixed processing lines should be identified. Lubricants, heating fluids, coolants and similar should not contact product in a way that alters quality; any such event should be evaluated for harm to fitness for use, and food-grade lubricants and oils used wherever possible. Closed or contained equipment is preferred where it suits the step, with precautions when equipment is open. Current drawings should be kept for equipment and critical installations such as instrumentation and utilities.