Water System Qualification (WFI, PW, RO)

Troubleshooting Biofilm in Purified Water Systems

Troubleshooting Biofilm in Purified Water Systems Troubleshooting Biofilm in Purified Water Systems In the pharmaceutical industry, maintaining the integrity of purified water systems is paramount, especially given the potential for biofilm formation. This article provides a comprehensive step-by-step tutorial on…

Writing a Water System IQ/OQ/PQ Protocol

Writing a Water System IQ/OQ/PQ Protocol Writing a Water System IQ/OQ/PQ Protocol Effective cleaning validation in the pharmaceutical industry is paramount to ensure product quality and patient safety. This step-by-step guide details the essential phases of writing an IQ/OQ/PQ protocol…

Continuous Monitoring Requirements for PW/WFI Systems

Continuous Monitoring Requirements for PW/WFI Systems Continuous Monitoring Requirements for PW/WFI Systems Ensuring the integrity and quality of Purified Water (PW) and Water for Injection (WFI) systems is critical in the pharmaceutical industry. For professionals involved in Quality Assurance (QA),…

Regulatory Audit Observations on Water System Validation

Regulatory Audit Observations on Water System Validation Regulatory Audit Observations on Water System Validation 1. Understanding the User Requirement Specification (URS) and Risk Assessment In the pharmaceutical industry, the development of a water system for purposes such as producing Water…

PQ Testing Schedule for Newly Installed Water Loops

PQ Testing Schedule for Newly Installed Water Loops PQ Testing Schedule for Newly Installed Water Loops The validation lifecycle for newly installed water loops is critical to ensure compliance with regulatory standards and operational effectiveness. This article aims to provide…

Differences in Validating Non-Compendial vs Compendial Water

Differences in Validating Non-Compendial vs Compendial Water Differences in Validating Non-Compendial vs Compendial Water In the pharmaceutical industry, ensuring the quality of water systems—whether compendial or non-compendial—is critical for product safety, efficacy, and compliance with regulatory standards. This article provides…