Tag: pq oq iq

Route Qualification During Natural Disasters or Emergencies

Route Qualification During Natural Disasters or Emergencies Route Qualification During Natural Disasters or Emergencies In the pharmaceutical and biologics sectors, transportation and storage conditions must be meticulously validated to ensure product integrity and compliance with regulatory requirements. This article serves…

Accelerated Stability Testing with New Packaging Systems

Accelerated Stability Testing with New Packaging Systems Accelerated Stability Testing with New Packaging Systems In the highly regulated pharmaceutical industry, ensuring that new packaging systems effectively protect their contents is paramount. The reliability of these systems must undergo rigorous validation,…

Classification Requirements for Support Areas and Material Transfer Zones

Classification Requirements for Support Areas and Material Transfer Zones Classification Requirements for Support Areas and Material Transfer Zones In the pharmaceutical and biologics industries, maintaining a controlled environment is paramount to ensuring product quality and regulatory compliance. The classification of…

Deviations in Protocol Execution: Documentation & CAPA

Deviations in Protocol Execution: Documentation & CAPA Deviations in Protocol Execution: Documentation & CAPA In the pharmaceutical industry, maintaining compliance with regulatory guidelines while executing validation protocols is critical to ensuring product quality and patient safety. This tutorial will provide…

Linking the VMP to the Quality Manual and Site Master File

Linking the VMP to the Quality Manual and Site Master File Linking the VMP to the Quality Manual and Site Master File In the pharmaceutical industry, ensuring the integrity and effectiveness of processes is paramount for compliance and quality assurance.…

GAMP 5 Annexes: How to Use Them Effectively

GAMP 5 Annexes: How to Use Them Effectively GAMP 5 Annexes: How to Use Them Effectively In the pharmaceutical and biotechnology industries, adherence to regulatory requirements is crucial. The GAMP 5 guidelines provide a framework for ensuring that computer systems…

Handling Deviations During Equipment Qualification

Handling Deviations During Equipment Qualification Handling Deviations During Equipment Qualification In the pharmaceutical industry, equipment qualification is a vital component of the validation lifecycle. This article serves as a detailed step-by-step tutorial on handling deviations during the equipment qualification phases…

Lifecycle Validation: Why Stage 1 Is the Foundation

Lifecycle Validation: Why Stage 1 Is the Foundation Lifecycle Validation: Why Stage 1 Is the Foundation This comprehensive guide walks you through the critical first stage of the validation lifecycle, focusing on the importance of understanding and executing effective process…