Packaging System Validation

Stability Failures Due to Packaging Migration: Root Cause Analysis

Stability Failures Due to Packaging Migration: Root Cause Analysis Stability Failures Due to Packaging Migration: Root Cause Analysis Stability failures often occur within pharmaceutical and medical device manufacturing, particularly when there are interactions between the product and its packaging materials.…

Drug-Container Interaction Testing and Leachable Assessment

Drug-Container Interaction Testing and Leachable Assessment Drug-Container Interaction Testing and Leachable Assessment In the pharmaceutical industry, ensuring the integrity and efficacy of drug products throughout their shelf life is paramount. A crucial aspect of this assurance lies in understanding the…

Validating Child-Resistant and Senior-Friendly Packaging

Validating Child-Resistant and Senior-Friendly Packaging Validating Child-Resistant and Senior-Friendly Packaging The validation of child-resistant and senior-friendly packaging is vital for safeguarding vulnerable populations while ensuring product integrity. Following the ISO 11137-1 guidelines and regulatory expectations from the FDA, EMA, and…

Compatibility Studies for High-Humidity and Cold Storage Zones

Compatibility Studies for High-Humidity and Cold Storage Zones Compatibility Studies for High-Humidity and Cold Storage Zones In the pharmaceutical and medical device industries, ensuring that products maintain their integrity and effectiveness under various environmental conditions is critical. This involves rigorous…

How to Document Packaging Justification in Regulatory Filings

How to Document Packaging Justification in Regulatory Filings How to Document Packaging Justification in Regulatory Filings In the highly regulated environment of the pharmaceutical industry, proper documentation of packaging justification is pivotal for ensuring compliance with various guidelines, including those…

Packaging Material Change Impact on Shelf Life Claims

Packaging Material Change Impact on Shelf Life Claims Packaging Material Change Impact on Shelf Life Claims In the pharmaceutical industry, maintaining product integrity and ensuring that shelf life claims are substantiated is critical for regulatory compliance and consumer safety. A…

Designing Packaging for Products with Narrow Stability Margins

Designing Packaging for Products with Narrow Stability Margins Designing Packaging for Products with Narrow Stability Margins In the highly regulated pharmaceutical industry, ensuring the proper packaging of products with narrow stability margins is critical for maintaining quality and efficacy. This…

Regulatory Guidelines on Packaging Stability Data Submission

Regulatory Guidelines on Packaging Stability Data Submission Regulatory Guidelines on Packaging Stability Data Submission In the pharmaceutical industry, ensuring the safety and efficacy of drug products relies heavily on robust validation processes. Among these, pharmaceutical process validation is critical to…

Bridging Studies Between Old and New Packaging Systems

Bridging Studies Between Old and New Packaging Systems Bridging Studies Between Old and New Packaging Systems In the constantly evolving pharmaceutical landscape, bridging studies are crucial for ensuring that new packaging systems maintain the integrity and stability of the packaged…

Confirming Packaging Inertness for Biologics and Injectables

Confirming Packaging Inertness for Biologics and Injectables Confirming Packaging Inertness for Biologics and Injectables In the pharmaceutical industry, ensuring the integrity and efficacy of biologics and injectables is paramount. A critical component of this assurance is the validation of packaging…