Tag: Transport & Cold Chain Validation

Stability Data Use in Excursion Impact Justification

Stability Data Use in Excursion Impact Justification Stability Data Use in Excursion Impact Justification The proper handling of temperature excursions is a critical concern in the pharmaceutical industry, particularly for products that require strict temperature controls during transport and storage.…

CAPA Plans Triggered by Cold Chain Deviations

CAPA Plans Triggered by Cold Chain Deviations CAPA Plans Triggered by Cold Chain Deviations Cold chain management is pivotal in the pharmaceutical industry, especially for temperature-sensitive products. Deviations in temperature during the transport of these products can lead to significant…

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…

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…

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…

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…

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…

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…

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…

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…