P3-A 002:2008

P3-A 002:2008

Pharmaceutical 3-A Sanitary/Hygienic Standards for Materials for Use in Process Equipment and Systems



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.

Additional Info

Author 3-A Pharmaceutical Standards
Published by 3A
Document type Standard
Theme /subgroups/21900
Edition 1
Number of pages 23
Weight(kg.) 0.1391
Keyword P3-A 002:2008