Tag: Packaging System Validation

Drug-Container Interaction Testing and Leachable Assessment

Drug-Container Interaction Testing and Leachable Assessment Drug-Container Interaction Testing and Leachable Assessment In the pharmaceutical industry, ensuring the integrity and efficacy of drug products throughout their shelf life is paramount. A crucial aspect of this assurance lies in understanding the…

Stability Failures Due to Packaging Migration: Root Cause Analysis

Stability Failures Due to Packaging Migration: Root Cause Analysis Stability Failures Due to Packaging Migration: Root Cause Analysis Stability failures often occur within pharmaceutical and medical device manufacturing, particularly when there are interactions between the product and its packaging materials.…

Accelerated vs Long-Term Stability Protocols Linked to Packaging

Accelerated vs Long-Term Stability Protocols Linked to Packaging Accelerated vs Long-Term Stability Protocols Linked to Packaging In the pharmaceutical industry, ensuring the long-term stability and integrity of products is paramount. Stability testing protocols, both accelerated and long-term, are critical components…

Simulating Transportation Conditions for Packaging-Product Stability

Simulating Transportation Conditions for Packaging-Product Stability Simulating Transportation Conditions for Packaging-Product Stability The validation of packaging systems is critical in ensuring the stability and integrity of pharmaceutical products throughout their lifecycle, particularly during transportation. This article provides a comprehensive, step-by-step…

How to Perform Light Transmission and Moisture Permeation Testing

How to Perform Light Transmission and Moisture Permeation Testing How to Perform Light Transmission and Moisture Permeation Testing 1. Understanding User Requirements and Risk Assessment The first step in the validation lifecycle of light transmission and moisture permeation testing is…

Packaging System Compatibility with Product Stability: A Complete Guide

Packaging System Compatibility with Product Stability: A Complete Guide Packaging System Compatibility with Product Stability: A Complete Guide Step 1: Define User Requirements Specification (URS) and Perform Risk Assessment In the context of packaging system validation, initiating the validation lifecycle…

Validation of Aggregation Systems for Multilevel Traceability

Validation of Aggregation Systems for Multilevel Traceability Validation of Aggregation Systems for Multilevel Traceability As pharmaceutical companies increasingly adopt complex aggregation systems for multilevel traceability, the need for robust computer system validation (CSV) becomes paramount. Ensuring compliance with regulatory standards…

GAMP5 Considerations for Serialization Software Systems

GAMP5 Considerations for Serialization Software Systems GAMP5 Considerations for Serialization Software Systems In the pharmaceutical industry, the integrity and security of product serialization systems are critical for compliance with regulatory mandates and for ensuring patient safety. Computer system validation (CSV)…

Human-Machine Interface (HMI) Validation in Coding Units

Human-Machine Interface (HMI) Validation in Coding Units Human-Machine Interface (HMI) Validation in Coding Units The role of Human-Machine Interfaces (HMIs) in the pharmaceutical industry, particularly in coding units, necessitates strict compliance with regulatory expectations and best practices. The validation of…

Case Study: Batch Recall Due to Serialization System Failure

Case Study: Batch Recall Due to Serialization System Failure Case Study: Batch Recall Due to Serialization System Failure This detailed article serves as a practical guide for pharmaceutical professionals focusing on computer system validation in pharmaceuticals. It aims to improve…