Outsourced Activities in Good Distribution Practice (GDP): A Critical Responsibility Outsourcing is common, but it doesn't mean offloading responsibility. Under EU GDP guidelines, when a wholesale distributor outsources any activity (e.g., storage, transportation, or repackaging), they retain full responsibility for ensuring that these activities comply with GDP standards. Whether working with third-party logistics providers or external contractors, key expectations include:

Should you employ an RP in-house - or contract one externally? Key Benefits of a Contract RP: Reduced operational and compliance costs Objective, external perspective on your quality system Flexible support tailored to your business model Peace of mind during MHRA inspections https://www.traingdp.co.uk/

Who is Cogent (Skills)? Cogent Skills (often simply “Cogent”) is the UK’s sector skills council for science-based industries. It works to develop, design, and deploy skills programmes in collaboration with employers and the government. Why did the MHRA collaborate with Cogent? The MHRA (Medicines and Healthcare products Regulatory Agency) collaborated with Cogent to jointly develop the Responsible Person Gold Standard and its corresponding Training Standard. This was first pu

In the world of pharmaceuticals, quality isn’t just a goal—it’s a responsibility. Medicines travel a long journey from manufacturer to...