In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
A large quantity of unstructured data is produced by the healthcare sector from electronic health records (EHRs), clinical notes, medical publications, social media, and regulatory papers. In order to provide insights, facilitate stakeholder communication, and promote evidence-based decision-making, medical affairs professionals need to effectively navigate this enormous information ecosystem. An
Internal audits play a crucial role in strengthening an organization’s Quality Management System (QMS) by identifying gaps, ensuring compliance, and fostering a culture of continuous improvement. Unlike external audits, internal audits provide a more flexible and less stressful environment for organizations to assess and improve their processes. Why Perform Internal
