Packaging System Validation

Integrity Testing of Pre-Filled Syringes and Pen Injectors

Integrity Testing of Pre-Filled Syringes and Pen Injectors Integrity Testing of Pre-Filled Syringes and Pen Injectors Integrity Testing of Pre-Filled Syringes and Pen Injectors – Practical guide for pharma professionals on iq oq with GMP, FDA and EMA compliance. Step…

How to Validate Barcode and Serialization Compliance

How to Validate Barcode and Serialization Compliance How to Validate Barcode and Serialization Compliance Validation in the pharmaceutical sector is a critical element to ensure that all processes yield products of the required quality, effectiveness, and safety. This article serves…

Change Control and Revalidation for Primary Packaging Components

Change Control and Revalidation for Primary Packaging Components Change Control and Revalidation for Primary Packaging Components In the pharmaceutical industry, the validation of packaging systems is critical to ensure product quality and compliance with regulatory requirements. This article is a…

Compatibility Studies Between Drug Product and Packaging

Compatibility Studies Between Drug Product and Packaging Compatibility Studies Between Drug Product and Packaging The pharmaceutical industry mandates stringent guidelines for ensuring the compatibility of drug products with their packaging. The significance of assessing this compatibility cannot be overstated, as…

Vendor Qualification Requirements for Primary Packaging Suppliers

Vendor Qualification Requirements for Primary Packaging Suppliers Vendor Qualification Requirements for Primary Packaging Suppliers In the pharmaceutical industry, vendor qualification is a critical process that ensures the reliability and quality of suppliers, particularly those providing primary packaging components. This guide…

Stability Impact of Packaging Material on Shelf Life

Stability Impact of Packaging Material on Shelf Life Stability Impact of Packaging Material on Shelf Life In today’s pharmaceutical landscape, the choice and validation of packaging materials is crucial in ensuring the stability and efficacy of products throughout their shelf…

How to Validate Cartons, Labels, and Inserts in Pharma Packaging

How to Validate Cartons, Labels, and Inserts in Pharma Packaging How to Validate Cartons, Labels, and Inserts in Pharma Packaging In the highly regulated pharmaceutical industry, validating packaging systems is critical to ensuring that medications are properly labeled, packaged, and…

Qualification Report Format for Packaging Materials

Qualification Report Format for Packaging Materials Qualification Report Format for Packaging Materials Qualification of packaging materials is a critical aspect of pharmaceutical manufacturing and regulatory compliance. The use of electronic validation software such as ValGenesis, and adherence to guidance from…

Validation of Shipper Boxes and Pallet Configuration for Transport

Validation of Shipper Boxes and Pallet Configuration for Transport Validation of Shipper Boxes and Pallet Configuration for Transport In the pharmaceutical and medical device industries, the validation of packaging systems is crucial for ensuring that products remain stable, effective, and…

Material of Construction Certificates in Packaging Qualification

Material of Construction Certificates in Packaging Qualification Material of Construction Certificates in Packaging Qualification This article provides a comprehensive step-by-step guide for pharma professionals on the validation plan for software specifically related to Packaging Material Qualification. It addresses key considerations…