Tag: pharmaceutical validation

How to Handle Incomplete or Terminated Validation Reports

How to Handle Incomplete or Terminated Validation Reports How to Handle Incomplete or Terminated Validation Reports In the pharmaceutical industry, validation is a critical process ensuring that products consistently meet quality standards. However, situations may arise leading to incomplete or…

Report Sign-Off Workflow: QA, Validation, and Engineering

Report Sign-Off Workflow: QA, Validation, and Engineering Report Sign-Off Workflow: QA, Validation, and Engineering In the pharmaceutical industry, robust validation practices are essential to ensure that products are safe, effective, and compliant with regulatory requirements. This article serves as a…

Using a Product Family Approach in VMP Planning

Using a Product Family Approach in VMP Planning Using a Product Family Approach in VMP Planning The pharmaceutical validation process is a critical aspect of ensuring that a product consistently meets quality standards throughout its lifecycle. This article provides a…

VMP Implementation Dashboard Template for QA/QC Leaders

VMP Implementation Dashboard Template for QA/QC Leaders VMP Implementation Dashboard Template for QA/QC Leaders The pharmaceutical industry operates under stringent regulations for quality assurance to ensure safety and efficacy in drug development and manufacturing. The Validation Master Plan (VMP) is…

Linking the VMP to Tech Transfer and Expansion Projects

Linking the VMP to Tech Transfer and Expansion Projects Linking the VMP to Tech Transfer and Expansion Projects Step 1: Understanding the Validation Master Plan (VMP) The Validation Master Plan (VMP) serves as a comprehensive framework guidance for validation activities…

Audit Trail Review: Frequency, Documentation, and Responsibility

Audit Trail Review: Frequency, Documentation, and Responsibility Audit Trail Review: Frequency, Documentation, and Responsibility In the context of pharmaceutical validation, maintaining data integrity is paramount. Audit trails are key components in computerized systems used within the pharmaceutical industry. This article…

Training Requirements Under 21 CFR Part 11

Training Requirements Under 21 CFR Part 11 Training Requirements Under 21 CFR Part 11 In the rapidly evolving landscape of the pharmaceutical industry, rigorous compliance with regulatory standards is essential. The implementation and validation of computer systems governed by 21…

Part 11-Compliant Backup and Disaster Recovery Validation

Part 11-Compliant Backup and Disaster Recovery Validation Part 11-Compliant Backup and Disaster Recovery Validation The validation of computer systems used in the pharmaceutical industry is a crucial undertaking. With the increasing reliance on electronic systems for data management, ensuring compliance…

Qualification of Water Purification Equipment (RO, WFI, PW)

Qualification of Water Purification Equipment (RO, WFI, PW) Qualification of Water Purification Equipment (RO, WFI, PW) In the pharmaceutical industry, robust equipment qualification is essential to ensure that water purification systems meet stringent regulatory standards. This article provides a step-by-step…

Legacy Equipment Risk Matrix Template (Downloadable)

Legacy Equipment Risk Matrix Template (Downloadable) Legacy Equipment Risk Matrix Template (Downloadable) In the context of the pharmaceutical validation lifecycle, ensuring the integrity and compliance of legacy equipment is vital for maintaining product quality and regulatory approval. This article provides…