ASTM E2476-09 Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

ASTM, 2009. — 11 p.This document provides guidance on the implementation of risk assessment and risk control for Process Analytical Technology (PAT) processes within the pharmaceutical industry. Wherever possible, other appropriate standards on risk assessment/management have been referenced and acknowledged. Where practical, further details of methods and additional references have been provided for information within the appendixes.