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...