Tag: Packaging System Validation

Print Quality Validation for 2D Codes, Datamatrix & Barcodes

Print Quality Validation for 2D Codes, Datamatrix & Barcodes Print Quality Validation for 2D Codes, Datamatrix & Barcodes In today’s pharmaceutical landscape, ensuring product integrity through effective print quality validation for 2D codes, DataMatrix, and barcodes is essential. This article…

How to Validate a Serialization System: Pharma Industry Guide

How to Validate a Serialization System: Pharma Industry Guide How to Validate a Serialization System: Pharma Industry Guide Step 1: Understanding User Requirements Specification (URS) and Risk Assessment The first phase in the validation lifecycle for a serialization system begins…

Packaging Line Clearance and Line Reconciliation Validation

Packaging Line Clearance and Line Reconciliation Validation Packaging Line Clearance and Line Reconciliation Validation Packaging line clearance and line reconciliation validation are critical components in the pharmaceutical manufacturing cycle. These processes ensure that packaging systems operate optimally, preventing cross-contamination and…

Regulatory Audit Expectations for Blister and Strip Packaging

Regulatory Audit Expectations for Blister and Strip Packaging Regulatory Audit Expectations for Blister and Strip Packaging In the pharmaceutical and biologics industries, packaging systems are crucial for ensuring product quality, safety, and efficacy. The validation of blister and strip packaging…

Training Requirements for Operators on Blister Line Validation

Training Requirements for Operators on Blister Line Validation Training Requirements for Operators on Blister Line Validation In the pharmaceutical industry, where the integrity and quality of products are paramount, the validation of packaging systems is critical. This article provides a…

Case Study: CCI Failure in High-Speed Blister Line

Case Study: CCI Failure in High-Speed Blister Line Case Study: CCI Failure in High-Speed Blister Line This article serves as a comprehensive guide for pharmaceutical professionals engaged in fda system validation, specifically focusing on the validation lifecycle of blister and…

Tooling Qualification for Format Parts in Blister Machines

Tooling Qualification for Format Parts in Blister Machines Tooling Qualification for Format Parts in Blister Machines In the pharmaceutical industry, the validation of packaging systems, including blister machines, is crucial for ensuring product integrity, efficacy, safety, and compliance with regulatory…

Data Integrity in Batch Coding and Label Printing Systems

Data Integrity in Batch Coding and Label Printing Systems Data Integrity in Batch Coding and Label Printing Systems In the pharmaceutical industry, ensuring the integrity of data across various systems is crucial, especially within batch coding and label printing systems.…

SOP for In-Process Controls on Blister Packaging Lines

SOP for In-Process Controls on Blister Packaging Lines SOP for In-Process Controls on Blister Packaging Lines This article provides a comprehensive step-by-step tutorial on the validation lifecycle for in-process controls on blister packaging lines, especially focusing on computerized system validation…

Print Registration and Barcode Validation in Strip Packs

Print Registration and Barcode Validation in Strip Packs Print Registration and Barcode Validation in Strip Packs The validation of print registration and barcode systems in pharmaceutical strip packing is critical to ensure product integrity and compliance with regulatory requirements. This…