With growing demand for GLP-1s, their supply chain integrity is vital. This article shows how EU Good Distribution Practice (GDP) and data operations (DataOps) help people manage these temperature-sensitive medicines in Europe. GLP-1s: Temperature Control GLP-1 drugs, for diabetes and obesity, are showing promise for other conditions, increasing demand. Global sales hit $53.6B (approximately £42.34B […]
As the Maly IT team, we understand the benefits of adopting good practices in the pharmaceutical industry. Ever mindful that the health and well-being of individuals depends on the quality, safety, and efficacy of medicinal products. Therefore, we agree that helping our customers to assure adherence to stringent guidelines and regulations is paramount. What are
As demand for Glucagon-like peptide-1 (GLP-1) therapies grows, maintaining their integrity across the international supply chain is a complex logistical challenge. It requires meticulous cold chain management to prevent spoilage and to safeguard patient outcomes. This article aims to focus on managing temperature excursions for a specific category of products. It expands on a previous
Escalating demand for temperature-sensitive biologics, vaccines, and advanced therapies intensifies the challenge of maintaining stringent temperature control throughout the entire distribution network, argues Richard Maly. The Imperative of Temperature Control Temperature excursions are defined as any deviation from a pharmaceutical product’s specified temperature range during its storage, transport, or handling, as determined by the manufacturer’s
Norfolk Hospital Joins Groundbreaking Generation Study Here at Maly IT, we’re really pleased to hear that our local Norfolk and Norwich University Hospital (NNUH) is taking part in the pioneering Generation Study. This national research project aims to transform how over 200 rare genetic conditions are diagnosed in newborns. The study will offer whole genome
Building upon Part 1’s exploration of product labelling as a defence against counterfeiting, this article (Part 2) delves into the intricate process of managing pharmaceutical labelling changes, crucial for compliance, minimising waste, and maintaining efficient supply chains across multiple markets. The seemingly simple act of changing a word or updating a logo on a pharmaceutical
The biopharmaceutical landscape is undergoing a significant transformation, driven by the increasing reliance on in silico simulations in drug discovery and therapeutics development. This computational approach offers a powerful tool for researchers. It allows for the prediction of drug-target interactions. Lead compounds can be optimised. The behaviour of molecules within biological systems can be simulated.
Credit: International Institute for Management Development (IMD) This February, I have decided to return to the topic of future readiness of pharmaceutical companies. It is a topic which has been gnawing away at me for well over a year, even before I first wrote about it (see Pulse 19 March 2024). Future readiness – a
Process compliance is crucial in new drug development and testing as it ensures that all regulatory requirements are met at each stage, from discovery to post-marketing surveillance. Compliance involves rigorous scientific research, data integrity, and adherence to Good Manufacturing Practices (GMP) and regulatory submissions such as the Clinical Trial Application (CTA) (Investigational New Drug –
Ever wondered what it’s like to run a genomics lab? There are a lot of complex procedures and processes to follow when carrying out hundreds of daily tests and experiments to ensure sampling is done correctly and that data gathered is accurate. The stakes are high for lab managers! Get it wrong even once and it
