Process Capability & Range Justification

Process Capability Case Studies in OSD and Sterile Manufacturing

Process Capability Case Studies in OSD and Sterile Manufacturing Process Capability Case Studies in OSD and Sterile Manufacturing Step 1: Define User Requirements and Conduct Risk Assessment The first step in the validation lifecycle is to establish the User Requirements…

Challenges in Scaling Process Ranges from Pilot to Commercial Scale

Challenges in Scaling Process Ranges from Pilot to Commercial Scale Challenges in Scaling Process Ranges from Pilot to Commercial Scale In the pharmaceutical industry, the transition from pilot to commercial scale involves a multitude of validation steps that ensure processes…

Aligning Equipment Qualification Data with Process Capability

Aligning Equipment Qualification Data with Process Capability Aligning Equipment Qualification Data with Process Capability Step 1: User Requirement Specification (URS) and Risk Assessment The initial step in the validation lifecycle involves defining the User Requirement Specification (URS), which documents the…

Cross-functional Roles in Setting and Verifying Process Ranges

Cross-functional Roles in Setting and Verifying Process Ranges Cross-functional Roles in Setting and Verifying Process Ranges In the highly regulated pharmaceutical industry, ensuring process validation is a critical step in the lifecycle of drug development. The validation of processes not…

Out of Trend (OOT) Analysis and its Role in Process Capability

Out of Trend (OOT) Analysis and its Role in Process Capability Out of Trend (OOT) Analysis and its Role in Process Capability In the pharmaceutical industry, process validation is critical for ensuring product consistency and quality. Among the various facets…

Documentation Requirements for Process Range Justification

Documentation Requirements for Process Range Justification Documentation Requirements for Process Range Justification Process validation is integral to the pharmaceutical industry, ensuring that products meet predetermined specifications for quality, safety, and efficacy. This article serves as a comprehensive guide to understanding…

How to Determine Normal Operating and Proven Acceptable Ranges

How to Determine Normal Operating and Proven Acceptable Ranges How to Determine Normal Operating and Proven Acceptable Ranges Determining Normal Operating Ranges (NOR) and Proven Acceptable Ranges (PAR) is a critical step in the process validation lifecycle of pharmaceutical and…

Impact of Raw Material Variability on Process Capability

Impact of Raw Material Variability on Process Capability Impact of Raw Material Variability on Process Capability The pharmaceutical industry is governed by stringent regulations designed to ensure the safety, efficacy, and quality of products. A significant factor in ensuring product…

Bridging Development Data to Commercial Range Justification

Bridging Development Data to Commercial Range Justification Bridging Development Data to Commercial Range Justification Validation is a critical component of pharmaceutical development and production, ensuring that processes yield products that meet predefined quality requirements consistently. This article serves as a…

Statistical Tools for Analyzing Process Capability

Statistical Tools for Analyzing Process Capability Statistical Tools for Analyzing Process Capability In the highly regulated pharmaceutical industry, ensuring process capability is critical for maintaining product quality and compliance with regulations. This article serves as a comprehensive, step-by-step guide to…