ICH Q8 – Quality by Design
The ICH Q8 guideline focuses on pharmaceutical development. It aims to establish a systematic approach to designing, developing, and manufacturing pharmaceutical products. This guideline is…
From Simple to Spectacular: A Beginner’s Guide to Technical Drawings
Drawings are a graphical way of representing an idea, a concept, or an entity in a two-dimensional plane. It is one of the oldest…
The Complete CQV: Where to Start
Commissioning, Qualification, and Validation (CQV) in the life science pharmaceutical and medical device industries define a detailed and science-based process for the specification, design, and verification of…
As-Built Data: A Vital Component of Construction Project Handover
Maintaining as-built information is critical throughout the lifecycle of a facility project. As-built information contains pertinent data to support maintaining operations and project decision–making. Since it provides a method…
Factory Acceptance Test: The Beginning of Quality Built Equipment
When a customer is purchasing new factory equipment, it is important to verify it is rigorously evaluated before it is delivered to their site. Factory Acceptance Test (FAT)…
ICH Guidelines Decoded
The International Council for Harmonisation (ICH) is an organization that brings together regulatory authorities and the pharmaceutical industry from different regions…
