validation lifecycle pharma – Pharma Validation

Deciding When to Revalidate Using QRM Principles

Deciding When to Revalidate Using QRM Principles How to Decide When to Revalidate Using Quality Risk Management (QRM) Principles Revalidation in the pharmaceutical industry is essential for maintaining a consistent, GMP-compliant, and validated state of processes, systems, and equipment. However,…

Identifying What Changes Demand Revalidation

Identifying What Changes Demand Revalidation How to Identify Which Changes Require Revalidation in Pharma In pharmaceutical manufacturing, maintaining a validated state is a fundamental requirement of GMP. As systems, processes, and equipment evolve, the question arises: which changes demand revalidation?…

Defining Scope in a VMP: What to Include & Exclude for Regulatory Clarity

Defining Scope in a VMP: What to Include & Exclude for Regulatory Clarity Defining Scope in a Pharma VMP: What to Include & Exclude for Regulatory Clarity The Validation Master Plan (VMP) is a cornerstone document in pharmaceutical quality systems.…

OQ Protocols in Pharma: Testing Performance & Compliance

OQ Protocols in Pharma: Testing Performance & Compliance Operational Qualification (OQ) in Pharma: How to Test Equipment Performance and Ensure Compliance Operational Qualification (OQ) is the documented verification that equipment, systems, or instruments operate as intended throughout all anticipated operating…