Good Manufacturing Practice – Beyond Compliance to Quality Culture
Good Manufacturing Practice (GMP) is the backbone of pharmaceutical manufacturing, ensuring that medicines are consistently produced and controlled to quality standards. It is not just about regulatory compliance—it is a culture of excellence embedded in every stage of pharmaceutical production. A well-implemented GMP system reduces risks, enhances efficiency, and protects patient safety. Companies that embrace […]
The Challenges of Early Access Medicine Supply – Balancing Speed, Safety, and Compliance
Early access to medicines offers hope to patients with unmet medical needs, providing them with potentially life-saving treatments before full regulatory approval. However, while early access programmes (EAPs) serve a critical role in patient care, they also introduce significant regulatory, logistical, and ethical challenges. Pharmaceutical companies must balance the urgency of patient needs with strict […]
The Role of the Qualified Person in the Pharmaceutical Supply Chain – The Gatekeeper of Quality and Compliance
The Qualified Person (QP) plays a critical role in pharmaceutical supply chains, acting as the final gatekeeper to ensure that every batch of medicine released meets regulatory and quality requirements. The QP is legally responsible for ensuring that medicinal products comply with Good Manufacturing Practice (GMP) and that patient safety is always the top priority. Beyond batch release, the QP’s role […]
Hosting a Regulatory Inspection – A Blueprint for Success
Regulatory inspections are high-stakes events that can determine a pharmaceutical company’s ability to operate, supply medicines, and maintain its reputation. A failed inspection can lead to warning letters, supply chain disruptions, license suspensions, or even product recalls. Being inspection-ready at all times is not just about compliance with Good Manufacturing Practice (GMP)—it’s about embedding a quality culture that stands up to scrutiny. Companies […]
