Packaging System Validation

Air Permeability and Leak Rate Acceptance Criteria

Air Permeability and Leak Rate Acceptance Criteria Air Permeability and Leak Rate Acceptance Criteria Air permeability and leak rate acceptance criteria are crucial aspects of pharmaceutical packaging validation processes. Appropriate evaluations and qualifications ensure that the packaging systems effectively protect…

Revalidation of Blister Machines After Change in Format

Revalidation of Blister Machines After Change in Format Revalidation of Blister Machines After Change in Format Revalidation of blister packaging machines is a critical process in ensuring the continued quality, safety, and efficacy of pharmaceutical products. With the continual evolution…

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…

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…

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.…

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…

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…

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…

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…

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…