The Quality by Design (QbD) approach is gaining more significance during drug development. This comprehensive and proactive approach ensures quality is built into the drug…

Quality is paramount in any business. It signifies trustworthiness, reliability, and consistency. Without a defined measure of quality, products or services can become inconsistent, which…

Quality Assurance (QA) consultants are professionals with specialized expertise in ensuring that processes, products, and services meet established quality standards and regulatory requirements. These consultants…

Qualifications and Validations of Chromatographic Systems: HPLC I UPLC I LC-MS Why is the qualification of laboratory equipment necessary? Qualifying laboratory equipment is necessary to…

A Step-by-Step Guide for Facilities Requirements USFDA 21 CFR Part 600 is a regulation that outlines the standards and requirements for biologics, including their production…

Equipment Qualification in the Life Sciences Industry Definition: Equipment qualification (EQ) is a process to ensure that equipment used in the life sciences sector operates…

What is HVAC? HVAC stands for Heating, Ventilation, and Air Conditioning. It refers to the technologies and systems used to regulate indoor environmental conditions, ensuring…

Navigating GxP Compliance in Cloud-Based Systems Navigating GxP (Good Practice) compliance in cloud-based systems is essential for industries like pharmaceuticals, biotechnology, and medical devices that…

Contamination Control Strategy (CCS) Definition: A Contamination Control Strategy (CCS) is a structured approach designed to minimize the risk of contamination in sterile manufacturing environments…