Tag: ppq validation

Building a Central KPI Repository for Validation

Building a Central KPI Repository for Validation Building a Central KPI Repository for Validation In the pharmaceutical and biotech industries, establishing a comprehensive Key Performance Indicator (KPI) repository is essential for effective validation activities. This repository serves as a centralized…

Integration of CPV into Site Quality Management System (QMS)

Integration of CPV into Site Quality Management System (QMS) Integration of CPV into Site Quality Management System (QMS) The integration of Continued Process Verification (CPV) into the Site Quality Management System (QMS) is pivotal for ensuring ongoing compliance and regulatory…

How to Handle Media Fill Failures During an Inspection

How to Handle Media Fill Failures During an Inspection How to Handle Media Fill Failures During an Inspection In the pharmaceutical industry, ensuring the integrity of aseptic processes is critical. Media fill tests are essential components of process validation, particularly…

Risk-Based Requalification Plan for Facility Systems

Risk-Based Requalification Plan for Facility Systems Risk-Based Requalification Plan for Facility Systems In the pharmaceutical industry, maintaining compliance with regulatory expectations is paramount. The process of validation encompasses various stages, including Process Design, Qualification, Process Performance Qualification (PPQ), Continued Process…

Who Owns the Risk File? QA vs Engineering Debate

Who Owns the Risk File? QA vs Engineering Debate Who Owns the Risk File? QA vs Engineering Debate In the pharmaceutical industry, process validation is crucial in ensuring that products meet regulatory standards and are consistently produced with the highest…

Deviations in Method Validation and How to Document Them

Deviations in Method Validation and How to Document Them Deviations in Method Validation and How to Document Them Step 1: Understanding User Requirements and Risk Assessment When initiating the validation lifecycle for analytical methods, it is important to first define…

Qualification of Utility Isolation Valves and Sampling Points

Qualification of Utility Isolation Valves and Sampling Points Qualification of Utility Isolation Valves and Sampling Points Qualification of Utility Isolation Valves and Sampling Points is essential in the pharmaceutical industry to ensure compliance with regulations and maintain the integrity of…

Robustness Studies for Critical Quality Attributes (CQAs)

Robustness Studies for Critical Quality Attributes (CQAs) Robustness Studies for Critical Quality Attributes (CQAs) Robustness studies are vital for establishing and ensuring the pharmaceutical quality of a product. Central to this process is understanding Critical Quality Attributes (CQAs) and their…