GMP auditing is undergoing a period of transformation. As pharmaceutical manufacturing becomes more global, more digital, and more complex, regulators are placing greater emphasis on how organisations demonstrate control over quality systems. Audits are no longer viewed solely as periodic compli…

GMP auditing has evolved significantly over the past decade. As pharmaceutical operations become more complex and regulatory expectations continue to rise, traditional audit methods are no longer sufficient on their own. Manual processes, paper-based records, and reactive compliance models are b…

Regulatory and compliance risk is a constant concern for pharmaceutical and life sciences organisations. As regulatory scrutiny intensifies and global supply chains become more complex, the margin for error continues to narrow. Even minor compliance gaps can lead to inspection findings, operatio…

Good Manufacturing Practice (GMP) regulations form the backbone of pharmaceutical quality and patient safety worldwide. While the core principles of GMP are consistent globally, regulatory frameworks vary significantly depending on the authority overseeing compliance. For organisations operating…

Supplier audits play a critical role in maintaining Good Manufacturing Practice (GMP) compliance across the pharmaceutical supply chain. As regulatory expectations continue to rise, organisations are increasingly accountable not only for their internal processes but also for the quality systems …

Introduction Holding a WDA license is not a one time regulatory milestone. For businesses involved in wholesale distribution of medicinal products in the UK, renewal and ongoing maintenance of the licence are just as important as the initial approval. Many organisations assume that once the WD…