Tag: Process Robustness Studies

The Role of Design of Experiments (DoE) in Process Robustness

The Role of Design of Experiments (DoE) in Process Robustness The Role of Design of Experiments (DoE) in Process Robustness In the pharmaceutical industry, ensuring that manufacturing processes are robust, reliable, and compliant is paramount. The implementation of Design of…

Tools and Techniques for Assessing Process Robustness

Tools and Techniques for Assessing Process Robustness Tools and Techniques for Assessing Process Robustness Step 1: Understanding User Requirements and Risk Assessment Before initiating any validation project, it is essential to establish clear User Requirements Specifications (URS). The URS should…

Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q)

Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q) Regulatory Guidance on Process Robustness (FDA, EMA, ICH Q/Q) Step 1: User Requirements Specification (URS) and Risk Assessment The foundation of any robust pharmaceutical validation process begins with the User Requirements…

How to Design a Robustness Study During Process Validation

How to Design a Robustness Study During Process Validation How to Design a Robustness Study During Process Validation In the pharmaceutical industry, the assurance of product quality through validated processes is paramount. Process validation involves a thorough assessment of various…

Process Robustness in Pharmaceutical Manufacturing: A Complete Guide

Process Robustness in Pharmaceutical Manufacturing: A Complete Guide Process Robustness in Pharmaceutical Manufacturing: A Complete Guide Step 1: Understanding the User Requirements Specification (URS) and Risk Assessment Process validation begins with a clear understanding of the User Requirements Specification (URS).…