Tag: pharmaceutical cleaning validation

Sanitization and Requalification Schedule for Water Systems

Sanitization and Requalification Schedule for Water Systems Sanitization and Requalification Schedule for Water Systems In the pharmaceutical industry, maintaining the integrity and quality of water systems is essential for ensuring the safety and efficacy of products. Cleaning validation serves as…

CPP Deviations: Root Cause Analysis and CAPA Strategies

CPP Deviations: Root Cause Analysis and CAPA Strategies CPP Deviations: Root Cause Analysis and CAPA Strategies Step 1: Understanding User Requirements Specification (URS) and Risk Assessment In the validation lifecycle, the first step involves the development of the User Requirements…

FDA and ICH Guidelines on Critical Process Parameters

FDA and ICH Guidelines on Critical Process Parameters FDA and ICH Guidelines on Critical Process Parameters The intricacies surrounding pharmaceutical cleaning validation have been widely addressed by regulatory bodies such as the FDA and ICH. For professionals in the pharmaceutical…

How to Define and Justify Critical Quality Attributes (CQAs)

How to Define and Justify Critical Quality Attributes (CQAs) How to Define and Justify Critical Quality Attributes (CQAs) In the evolving landscape of the pharmaceutical industry, ensuring product quality is paramount. Critical Quality Attributes (CQAs) serve as vital parameters that…