Rebecca Beausang

If you have spent any time on a manufacturing floor, you know the feeling that kicks in when you hear an inspector has just signed into the lobby. I remember my first major site audit vividly. I had spent three weeks checking every single machine mai...

Finding the best compliance tools for pharmaceutical companies is now a survival requirement for any QARA professional overseen by increasing regulatory complexity and global supply chains. In this post, we’ll explain why pharmaceutical regulatory co...

If you’re a professional in pharmaceuticals, biotech, advanced therapy medicinal products (ATMPs), or medical devices operating in the UK, you know the gravity of an inspection conducted by the Medicines and Healthcare products Regulatory Agency (MHR...

If you're in pharmaceutical development, Quality by Design (QbD) is a term you know well. It represents an advancement in how we develop and manufacture medicines, and at its heart is the ICH Q8 guideline.

If you’ve ever been through an audit in the life sciences industry, you know how important Corrective and Preventive Actions (CAPAs) are. Regulatory bodies expect you to have a strong CAPA process in place to uphold product quality and patient safety...