活性药物成分（API）制造商已确定，需要制定更高效清洁的设备设计标准，以提高QA和检验机构的认可度，并推进生产设备的最先进水平。新的制药3-A（P3-A）标准规定了制造活性药物成分的建筑材料和可清洁设备的设计要求。本标准规定了制药环境中使用的新设备和组件的最低材料和表面性能要求，包括最低制造相关材料和表面性能要求，这些材料和表面性能可能直接、间接或附带影响强度、特性、安全性，活性药物成分、赋形剂或药品的纯度或质量。

Active pharmaceutical ingredient (API) manufacturers have identified the need for standards for the design of equipment that is more efficiently cleanable to enhance acceptance by QA and inspection agencies and advance the state-of-the-art for production equipment. The new Pharmaceutical 3-A (P3-A) standards provide the requirements for materials of construction and for the design of cleanable equipment for the manufacture of active pharmaceutical ingredients.This standard provides minimum materials and surface property requirements, including minimum fabrication related materials and surface property requirements, for new equipment and components utilized in the pharmaceutical manufacturing environment whereby those material and surface properties may directly, indirectly, or incidentally impact the strength, identity, safety, purity or quality of the active pharmaceutical ingredient, excipient, or drug product.