Tag: Transport & Cold Chain Validation

WHO PQS Standards and Compliance for Packaging

WHO PQS Standards and Compliance for Packaging WHO PQS Standards and Compliance for Packaging Understanding validation in pharmaceutics is crucial for professionals involved in the pharmaceutical packaging process. The transition from traditional methods to modern validation practices necessitates a comprehensive…

Validation Protocol for Cold Chain Packaging Systems

Validation Protocol for Cold Chain Packaging Systems Validation Protocol for Cold Chain Packaging Systems The validation of cold chain packaging systems is crucial for ensuring the efficacy and safety of temperature-sensitive pharmaceutical products. This comprehensive guide provides a step-by-step approach…

Distribution Qualification Studies Linked to Packaging Systems

Distribution Qualification Studies Linked to Packaging Systems Distribution Qualification Studies Linked to Packaging Systems In the pharmaceutical industry, rigorous validation processes are mandatory for ensuring the efficacy and safety of drug products during distribution. This article will guide QA, QC,…

Impact of External Temperature on Packaging Performance

Impact of External Temperature on Packaging Performance Impact of External Temperature on Packaging Performance Ensuring that pharmaceutical products are transported and stored under appropriate temperature conditions is critical to maintaining their integrity and efficacy. An inadequately validated packaging system may…

Real-Time Monitoring of Package Conditions During Transit

Real-Time Monitoring of Package Conditions During Transit Real-Time Monitoring of Package Conditions During Transit In the pharmaceutical industry, ensuring the integrity of products during transit is crucial. This article provides a comprehensive, step-by-step guide on the validation in a pharma…

Case Study: Validation Failure Due to Inadequate Packaging

Case Study: Validation Failure Due to Inadequate Packaging Case Study: Validation Failure Due to Inadequate Packaging This article aims to provide pharmaceutical professionals a methodical approach to understanding the validation lifecycle—specifically focusing on the failure due to inadequate packaging. By…

Packaging Qualification for Last-Mile Delivery

Packaging Qualification for Last-Mile Delivery Packaging Qualification for Last-Mile Delivery Packaging qualification for last-mile delivery is a critical component of the pharmaceutical validation process. This detailed guide aims to provide QA, QC, validation, and regulatory teams with the essential steps…

Reusability and Cleaning Validation of Active Shippers

Reusability and Cleaning Validation of Active Shippers Reusability and Cleaning Validation of Active Shippers 1. Understanding User Requirements and Risk Assessment The initial phase of the validation lifecycle involves defining the user requirements specifications (URS) and conducting a comprehensive risk…

Qualification of Phase Change Materials (PCMs) in Cold Chain

Qualification of Phase Change Materials (PCMs) in Cold Chain Qualification of Phase Change Materials (PCMs) in Cold Chain The pharmaceutical industry places great emphasis on maintaining product integrity throughout transport. This necessity elevates the role of Phase Change Materials (PCMs)…

Stability Studies Supporting Packaging Validation

Stability Studies Supporting Packaging Validation Stability Studies Supporting Packaging Validation In the pharmaceutical and biologics sectors, implementing robust validation processes is fundamental to ensuring product quality, safety, and efficacy. One essential aspect of validation is the performance qualification of packaging…