Tag: commissioning and qualification

How to Validate Insulated Shippers and Cold Chain Boxes

How to Validate Insulated Shippers and Cold Chain Boxes How to Validate Insulated Shippers and Cold Chain Boxes In the pharmaceutical and biotechnology industries, maintaining the integrity of temperature-sensitive products during transport is critical. This article provides a comprehensive, step-by-step…

How to Validate Cartons, Labels, and Inserts in Pharma Packaging

How to Validate Cartons, Labels, and Inserts in Pharma Packaging How to Validate Cartons, Labels, and Inserts in Pharma Packaging In the highly regulated pharmaceutical industry, validating packaging systems is critical to ensuring that medications are properly labeled, packaged, and…

Writing a Validation Summary Report That Passes Audits

Writing a Validation Summary Report That Passes Audits Writing a Validation Summary Report That Passes Audits Validation Summary Reports (VSRs) are critical components of the validation lifecycle in the pharmaceutical and medical device industries. They serve as comprehensive documents that…

Implementing a VMP Across Multiple Manufacturing Units

Implementing a VMP Across Multiple Manufacturing Units Implementing a VMP Across Multiple Manufacturing Units The implementation of a Validation Master Plan (VMP) across multiple manufacturing units is a crucial step in ensuring compliance with regulatory guidelines and maintaining product quality.…

What Is 21 CFR Part 11? A Complete Guide for Pharma QA

What Is 21 CFR Part 11? A Complete Guide for Pharma QA What Is 21 CFR Part 11? A Complete Guide for Pharma QA Step 1: Understanding the User Requirements Specification (URS) & Risk Assessment Before embarking on the commissioning…

How to Qualify Legacy Equipment in Existing Facilities

How to Qualify Legacy Equipment in Existing Facilities How to Qualify Legacy Equipment in Existing Facilities The qualification of legacy equipment in pharmaceutical and medical device manufacturing facilities is a critical competency for Quality Assurance (QA), Quality Control (QC), Validation,…

Writing a Process Qualification (PPQ) Protocol: Template and Guide

Writing a Process Qualification (PPQ) Protocol: Template and Guide Writing a Process Qualification (PPQ) Protocol: Template and Guide In the pharmaceutical and biologics industries, process validation is essential for ensuring that products are manufactured consistently to meet quality standards. The…