Tag: process validation

Statistical Analysis in Robustness Study: A Practical Guide

Statistical Analysis in Robustness Study: A Practical Guide Statistical Analysis in Robustness Study: A Practical Guide Conducting robustness studies within the pharmaceutical industry is an essential aspect of ensuring product quality and compliance with regulatory standards. The fundamental aim of…

Establishing Proven Acceptable Ranges Through Robustness Testing

Establishing Proven Acceptable Ranges Through Robustness Testing Establishing Proven Acceptable Ranges Through Robustness Testing Robustness testing is a critical aspect of process validation in the pharmaceutical industry. It supports the establishment of Proven Acceptable Ranges (PARs) necessary for the process…

Inter- and Intra-batch Variability: A Risk to Process Robustness

Inter- and Intra-batch Variability: A Risk to Process Robustness Inter- and Intra-batch Variability: A Risk to Process Robustness Ensuring robust pharmaceutical processes is paramount for maintaining product quality and meeting regulatory standards. The presence of inter- and intra-batch variability poses…

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…

How to Evaluate Edge of Failure and Normal Operating Ranges

How to Evaluate Edge of Failure and Normal Operating Ranges How to Evaluate Edge of Failure and Normal Operating Ranges The evaluation of the edge of failure and normal operating ranges is critical in ensuring that pharmaceutical processes remain within…

Identifying and Controlling Sources of Process Variability

Identifying and Controlling Sources of Process Variability Identifying and Controlling Sources of Process Variability In the highly regulated pharmaceutical environment, ensuring process robustness is critical for compliance and product quality. This comprehensive guide outlines a step-by-step validation process that adheres…

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…