iso 14644 2 – Pharma Validation

How to Set Up Real-Time Dashboards for Validation Activities

How to Set Up Real-Time Dashboards for Validation Activities How to Set Up Real-Time Dashboards for Validation Activities The validation lifecycle in pharmaceutical and biologics manufacturing is complex and regulatory-driven. Continuous monitoring and data visualization play crucial roles in ensuring…

Sterility Assurance Level (SAL) in Aseptic Processing Explained

Sterility Assurance Level (SAL) in Aseptic Processing Explained Sterility Assurance Level (SAL) in Aseptic Processing Explained In pharmaceutical manufacturing, particularly within aseptic processing, achieving an acceptable Sterility Assurance Level (SAL) is critical to ensure product safety and efficacy. The principles…

Change Control in Pharma: A Step-by-Step Implementation Guide

Change Control in Pharma: A Step-by-Step Implementation Guide Change Control in Pharma: A Step-by-Step Implementation Guide Change control is a critical process in the pharmaceutical industry, ensuring that any change made during the product lifecycle is properly documented, assessed, and…

How to Perform Criticality Assessment in Pharma Validation

How to Perform Criticality Assessment in Pharma Validation How to Perform Criticality Assessment in Pharma Validation The pharmaceutical industry is governed by a strict regulatory framework that ensures product quality and patient safety. One critical aspect of this framework is…

Method Robustness vs Ruggedness: What’s the Difference?

Method Robustness vs Ruggedness: What’s the Difference? Method Robustness vs Ruggedness: What’s the Difference? In the field of pharmaceutical validation, understanding the concepts of robustness and ruggedness is crucial for ensuring that analytical methods deliver reliable results consistently. This article…

Validating a Pharmaceutical Water System: RO, PW, WFI

Validating a Pharmaceutical Water System: RO, PW, WFI Validating a Pharmaceutical Water System: RO, PW, WFI Step 1: User Requirements Specification (URS) & Risk Assessment The validation process for a pharmaceutical water system begins with creating a robust User Requirements…

Acceptance Criteria for Holding Time Studies in Solid Dosage Manufacturing

Acceptance Criteria for Holding Time Studies in Solid Dosage Manufacturing Acceptance Criteria for Holding Time Studies in Solid Dosage Manufacturing Holding time studies are integral to ensuring the quality and integrity of solid dosage forms during manufacturing processes. The validation…