Pharmaceutical facility quality risk assessment for identifying and evaluating risks that may affect product quality. A reference for quality assurance, engineering and manufacturing teams preparing or reviewing facility risk assessments.
This document provides a reference for assessing facility-related risks within pharmaceutical quality risk management. It is intended to support quality assurance, engineering and manufacturing teams when preparing or reviewing a facility risk assessment.
Before use, review its applicability to your facility layout, operations, products and existing controls. Adapt the assessment to site-specific conditions and follow your organisation’s review and approval procedures.
Topics covered by this document
01API Facility Design and Infrastructure02Personnel Hygiene and Contamination Control03Cleaning, Sanitization and Pest Control04Equipment Qualification and Maintenance05Utilities, Purified Water and HVAC Systems06Material Handling, Storage and Transportation07Risk Identification, Scoring and Evaluation08Risk Mitigation and Residual Risk Review