Tag: Packaging System Validation

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…

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…

Software Validation for Serialization Control Systems

Software Validation for Serialization Control Systems Software Validation for Serialization Control Systems In the pharmaceutical industry, proper computer system validation (CSV) is crucial for ensuring compliance with regulatory requirements and quality standards. Serialization control systems represent a significant aspect of…

SOP for Label Reconciliation and Verification

SOP for Label Reconciliation and Verification SOP for Label Reconciliation and Verification In the pharmaceutical industry, ensuring compliance and proper validation of computer systems is critical for maintaining quality and safety standards. In line with regulatory requirements outlined by organizations…

Error-Proofing Labeling and Serialization Using Vision Systems

Error-Proofing Labeling and Serialization Using Vision Systems Error-Proofing Labeling and Serialization Using Vision Systems In the highly regulated pharmaceutical industry, ensuring the accuracy and reliability of labeling and serialization is paramount. This article outlines a comprehensive, step-by-step validation tutorial to…

Revalidation Requirements After Coding Format Changes

Revalidation Requirements After Coding Format Changes Revalidation Requirements After Coding Format Changes The implementation of coding format changes in pharmaceutical packaging systems is a critical area of the validation lifecycle. Incorporating changes in systems necessitates a comprehensive understanding of relevant…

Manual vs Automated Labeling: Validation Challenges and Tips

Manual vs Automated Labeling: Validation Challenges and Tips Manual vs Automated Labeling: Validation Challenges and Tips In the pharmaceutical industry, ensuring the integrity and reliability of labeling systems is critical for compliance with regulatory standards and maintaining product quality. This…

Integration of ERP and Serialization Systems in Validation

Integration of ERP and Serialization Systems in Validation Integration of ERP and Serialization Systems in Validation In the pharmaceutical industry, validation is a critical aspect of ensuring compliance with regulatory requirements and maintaining product integrity. This article serves as a…

Coding Equipment Qualification: IQ/OQ/PQ Protocols

Coding Equipment Qualification: IQ/OQ/PQ Protocols Coding Equipment Qualification: IQ/OQ/PQ Protocols In the pharmaceutical and biologics sectors, ensuring that coding equipment operates within defined specifications is critical for compliance with Good Manufacturing Practices (GMP) and other regulatory frameworks. This comprehensive guide…

Label Stock Qualification: Adhesive Strength, Print Durability

Label Stock Qualification: Adhesive Strength, Print Durability Label Stock Qualification: Adhesive Strength, Print Durability In the pharmaceutical industry, ensuring the integrity and compliance of packaging systems is paramount. One critical aspect of this process is the qualification of label stock,…