Stability & Compatibility with Packaging

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…

Real-Time Shelf Life Assessment with New Packaging Systems

Real-Time Shelf Life Assessment with New Packaging Systems Real-Time Shelf Life Assessment with New Packaging Systems In the pharmaceutical industry, the validation of packaging systems is crucial for ensuring product stability, safety, and efficacy over their intended shelf lives. This…

Case Study: Packaging Stability Risk Identified via CPV Data

Case Study: Packaging Stability Risk Identified via CPV Data Case Study: Packaging Stability Risk Identified via CPV Data Step 1: Developing the User Requirements Specification (URS) and Conducting a Risk Assessment The initiation of a pharmaceutical process validation lifecycle begins…