Deviation Handling & Temperature Excursions

How to Handle Temperature Excursions in Pharma Shipments

How to Handle Temperature Excursions in Pharma Shipments How to Handle Temperature Excursions in Pharma Shipments Step 1: Understanding Temperature Excursions and Regulatory Expectations Temperature excursions refer to deviations from the predefined temperature ranges that must be maintained during the…

Root Cause Analysis for Cold Chain Deviations

Root Cause Analysis for Cold Chain Deviations Root Cause Analysis for Cold Chain Deviations In the pharmaceutical and biologics industries, maintaining the integrity of products throughout the cold chain is critical. Any deviation can lead to significant regulatory, financial, and…

SOP Template: Deviation Handling During Product Transit

SOP Template: Deviation Handling During Product Transit SOP Template: Deviation Handling During Product Transit Transporting pharmaceutical products under controlled conditions is essential. This entails meticulous planning, risk assessment, and validation to comply with regulatory standards. The aim of this article…

Risk Assessment for Minor vs Major Temperature Excursions

Risk Assessment for Minor vs Major Temperature Excursions Risk Assessment for Minor vs Major Temperature Excursions The pharmaceutical industry is bound by rigorous regulatory expectations concerning the integrity and efficacy of products during transport and storage. Effective system validation processes…

Case Study: Excursion Impact on Biologics Shipment

Case Study: Excursion Impact on Biologics Shipment Case Study: Excursion Impact on Biologics Shipment This article provides a comprehensive, step-by-step tutorial on GxP validation relevant to the transport and cold chain validation of biologics, with a focus on deviation handling…

Deviation Trending in Cold Chain Management

Deviation Trending in Cold Chain Management Deviation Trending in Cold Chain Management In the pharmaceutical and biologics sectors, effective deviation trending within cold chain management is essential for ensuring the integrity of products subjected to temperature variations. This article provides…

Decision Trees for Product Disposition After Excursion

Decision Trees for Product Disposition After Excursion Decision Trees for Product Disposition After Excursion The pharmaceutical industry faces numerous challenges in maintaining compliance with regulations regarding the transport and storage of products, particularly when dealing with temperature excursions. Addressing these…

Excursion Logging, Justification, and QA Approval

Excursion Logging, Justification, and QA Approval Excursion Logging, Justification, and QA Approval Temperature excursions during the transportation and storage of pharmaceuticals can significantly impact the safety and efficacy of the products. This article provides a comprehensive step-by-step tutorial focused on…

Regulatory Requirements for Excursion Investigations

Regulatory Requirements for Excursion Investigations Regulatory Requirements for Excursion Investigations In the pharmaceutical and biologics industries, ensuring the integrity and quality of products during transport and cold chain management is of utmost importance. This is especially relevant during situations involving…

Common Excursion Causes and How to Prevent Them

Common Excursion Causes and How to Prevent Them Common Excursion Causes and How to Prevent Them 1. Understanding User Requirements Specifications (URS) and Risk Assessment The first step in the validation lifecycle of computer system validation in pharmaceuticals is to…