Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture Ingestion-build-48024 increasing safety

increasing safety

The insulating liquid sample is maintained at 120 °C in the presence of a solid copper catalyst whilst bubbling air at a constant flow

Symbols and units

test methods and optical

heat-treat scale

Standard Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture Ingestion-build-48024 increasing safety1. Scope 1. 1 This document provides guidance on the assessment of risks to product quality within and related to PAT processes in the pharmaceutical industry. It addresses those risks to product quality arising from, associated with, identified by, or modified by the implementation of PAT in pharmaceutical development and manufacturing for primary, secondary, and biotech sectors of the industry. It does not replace those assessments of risk currently