Process Validation

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…

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…

Case Studies on Process Robustness Across Different Dosage Forms

Case Studies on Process Robustness Across Different Dosage Forms Case Studies on Process Robustness Across Different Dosage Forms Step 1: Defining User Requirements Specification (URS) and Risk Assessment The first step in the validation lifecycle is to define the User…

Linking Process Robustness with Continued Process Verification (CPV)

Linking Process Robustness with Continued Process Verification (CPV) Linking Process Robustness with Continued Process Verification (CPV) In the fiercely regulated pharmaceutical and biotechnology industries, ensuring process robustness is crucial to product quality, safety, and efficacy. The journey toward achieving robust…

Integrating Robustness Assessment into Control Strategy

Integrating Robustness Assessment into Control Strategy Integrating Robustness Assessment into Control Strategy In the pharmaceutical industry, ensuring the quality and consistency of products is paramount. A critical aspect of this is the equipment qualification process, which is foundational for maintaining…

Lifecycle Management of Process Robustness Parameters

Lifecycle Management of Process Robustness Parameters Lifecycle Management of Process Robustness Parameters The qualification of equipment in the pharmaceutical industry is a multifaceted process essential for ensuring that manufacturing equipment and systems operate according to defined requirements. This article serves…