Process Parameters & Critical Control

Role of Design of Experiments (DoE) in Determining CPPs

Role of Design of Experiments (DoE) in Determining CPPs Role of Design of Experiments (DoE) in Determining CPPs Cleaning validation in the pharma industry is a critical aspect of ensuring product safety and efficacy. With the strict regulatory requirements outlined…

Documenting and Verifying Process Parameters in Validation Protocols

Documenting and Verifying Process Parameters in Validation Protocols Documenting and Verifying Process Parameters in Validation Protocols Step 1: User Requirement Specification (URS) and Risk Assessment The validation lifecycle commences with the establishment of a User Requirement Specification (URS). This document…

Automated Systems for Monitoring Critical Process Controls

Automated Systems for Monitoring Critical Process Controls Automated Systems for Monitoring Critical Process Controls In the pharmaceutical and biologics industries, the validation of processes is critical to ensuring product quality and regulatory compliance. As technologies evolve, the need for automated…

Impact of Equipment Variability on Process Parameter Control

Impact of Equipment Variability on Process Parameter Control Impact of Equipment Variability on Process Parameter Control This tutorial provides a detailed overview of the impact of equipment variability on process parameter control within the pharmaceutical industry. It traces the validation…

Lifecycle Approach to Maintaining and Reassessing CPPs

Lifecycle Approach to Maintaining and Reassessing CPPs Lifecycle Approach to Maintaining and Reassessing CPPs The lifecycle approach to maintaining and reassessing Critical Process Parameters (CPPs) is not only essential for operational efficiency in pharmaceutical manufacturing processes but is also crucial…