Validation Master Plan (VMP)

Reviewing the VMP During Annual Product Reviews (APR/PQR)

Reviewing the VMP During Annual Product Reviews (APR/PQR) Reviewing the VMP During Annual Product Reviews (APR/PQR) The validation lifecycle in a pharmaceutical company is crucial for ensuring compliance with regulatory standards and maintaining product quality. The Validation Master Plan (VMP)…

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…

Common Roadblocks in VMP Execution and How to Overcome Them

Common Roadblocks in VMP Execution and How to Overcome Them Common Roadblocks in VMP Execution and How to Overcome Them Step 1: Understanding the Validation Lifecycle in Pharma Validation in pharma companies is a structured process that encompasses several key…

Audit Trail and Version History for VMP Updates

Audit Trail and Version History for VMP Updates Audit Trail and Version History for VMP Updates The pharmaceutical industry is governed by stringent regulations and guidelines that ensure safety, quality, and efficacy in product development and manufacturing. As part of…

Integrating Risk-Based Validation Activities into Oversight Plans

Integrating Risk-Based Validation Activities into Oversight Plans Integrating Risk-Based Validation Activities into Oversight Plans Validation in pharmaceutics is a pivotal process to ensure that products meet safety, quality, and efficacy standards. FDA guidelines, EU GMP Annex 15, and ICH Q8-Q10…

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…

Who Owns the VMP? Governance Structure in Global Companies

Who Owns the VMP? Governance Structure in Global Companies Who Owns the VMP? Governance Structure in Global Companies The Validation Master Plan (VMP) is a critical framework that defines the validation strategy and its execution within pharmaceutical organizations. Governance structures…

How to Create a VMP for Multi-Product Pharma Sites

How to Create a VMP for Multi-Product Pharma Sites How to Create a VMP for Multi-Product Pharma Sites The pharmaceutical industry is governed by stringent regulations ensuring that products are safe, effective, and manufactured to high-quality standards. Creating a Validation…

Contract Manufacturing and the VMP: Who Does What?

Contract Manufacturing and the VMP: Who Does What? Contract Manufacturing and the VMP: Who Does What? In the pharmaceutical industry, validation plays an essential role in ensuring that products are developed, manufactured, and controlled to meet predefined quality standards. This…

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…