Tag: FDA guidelines

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…

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…

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…

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…

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…

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…

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…

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…

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.…

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…