Packaging System Validation

Regulatory Guidelines for Traceability and Coding Compliance

Regulatory Guidelines for Traceability and Coding Compliance Regulatory Guidelines for Traceability and Coding Compliance The regulatory landscape for traceability and coding compliance in the pharmaceutical industry emphasizes the necessity for robust validation processes, especially concerning computer systems. This tutorial will…

Real-Time Data Capture Validation on Packaging Lines

Real-Time Data Capture Validation on Packaging Lines Real-Time Data Capture Validation on Packaging Lines This article provides a comprehensive, step-by-step guide on the validation lifecycle for real-time data capture systems used on packaging lines in the pharmaceutical industry. Given the…

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…

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…

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)…

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…

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…

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…

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…

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…