annex 15 qualification and validation

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…

Revalidation Requirements After Coding Format Changes

Revalidation Requirements After Coding Format Changes Revalidation Requirements After Coding Format Changes The implementation of coding format changes in pharmaceutical packaging systems is a critical area of the validation lifecycle. Incorporating changes in systems necessitates a comprehensive understanding of relevant…

Terminal Filter Leak Testing in Critical Grade A and B Zones

Terminal Filter Leak Testing in Critical Grade A and B Zones Terminal Filter Leak Testing in Critical Grade A and B Zones This article provides a comprehensive, step-by-step validation tutorial focusing on terminal filter leak testing in critical Grade A…

Common Data Integrity Gaps Found in Validation Files

Common Data Integrity Gaps Found in Validation Files Common Data Integrity Gaps Found in Validation Files In the pharmaceutical industry, ensuring the integrity and compliance of validation documentation is critical. This article will guide you through a structured step-by-step validation…

Audit-Ready VMP Formatting Tips for Global Compliance

Audit-Ready VMP Formatting Tips for Global Compliance Audit-Ready VMP Formatting Tips for Global Compliance Step 1: Understanding the Validation Master Plan (VMP) The Validation Master Plan (VMP) serves as the cornerstone of validation activities within the pharmaceutical and biologics sectors.…

Spreadsheet Validation Protocol Sample for Audit Readiness

Spreadsheet Validation Protocol Sample for Audit Readiness Spreadsheet Validation Protocol Sample for Audit Readiness In the highly regulated pharmaceutical industry, ensuring compliance with validation requirements is vital for maintaining product quality and safety. With the implementation of regulations such as…

Qualification Deviations That Lead to Audit Findings

Qualification Deviations That Lead to Audit Findings Qualification Deviations That Lead to Audit Findings Effective qualification and validation of pharmaceutical processes and systems are critical to comply with regulatory requirements and ensure product quality. However, deviations during qualification can lead…

Protocol Approval Workflow for Process Validation

Protocol Approval Workflow for Process Validation Protocol Approval Workflow for Process Validation In the pharmaceutical and biologics industries, the protocol approval workflow is a critical component of the overall process validation lifecycle. This comprehensive guide outlines in detail the step-by-step…