Tag: Process Parameters & Critical Control

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…

Step-by-Step Guide to Setting Process Parameter Ranges

Step-by-Step Guide to Setting Process Parameter Ranges Step-by-Step Guide to Setting Process Parameter Ranges Establishing effective process parameter ranges is critical for the validation lifecycle within the pharmaceutical industry. This step-by-step guide focuses on specific validation tasks, documentation, data requirements,…

Process Control Strategy: Linking CPPs and CQAs in Validation

Process Control Strategy: Linking CPPs and CQAs in Validation Process Control Strategy: Linking CPPs and CQAs in Validation In the pharmaceutical industry, a robust validation strategy is essential to ensure that processes consistently yield products that meet predefined quality standards.…

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…

Identifying Critical Process Parameters (CPPs) in Pharmaceutical Validation

Identifying Critical Process Parameters (CPPs) in Pharmaceutical Validation Identifying Critical Process Parameters (CPPs) in Pharmaceutical Validation In the pharmaceutical industry, effective validation processes are crucial to ensure product quality, safety, and efficacy. A critical aspect of validation is identifying Critical…