Drug shortages rarely begin with a production stoppage. They usually begin months earlier, with a quality decision that seemed proportionate at the time. A deviation classified as Minor. A recurring environmental signal considered manageable. A supplier concern documented but not escalated. A maintenance delay accepted because output pressure was high. None of these decisions look dramatic in isolation. Yet they are often where the shortage story truly begins. By the time reg

On paper, most organisations can point to a Contamination Control Strategy, supported by procedures and risk assessments, with clear links into the quality system. From a distance, the framework looks sound. The challenge usually appears later, when inspectors stop reviewing documents and start asking people to explain how contamination risks are actually controlled day to day. At that point, even well-established systems can begin to feel fragile. This is not a skills gap. I

In cosmetics, product safety starts long before a product is opened. The integrity of your raw materials, packaging, and contracted operations determines whether your Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) stand up to scrutiny, and whether your brand can move quickly without compliance surprises. Under Regulation (EC) No. 1223/2009, the Responsible Person (RP) remains accountable for safety, GMP, and market compliance, even when activities ar