quality-assurance

We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system. CAPA is a systematic approach for identifying quality issues with products and then fixing those issues so they don’t happen again. Pharma companies (l…

Developing and manufacturing a stable and safe medical device is difficult for even the most experienced manufacturers. How can you ensure you manufacture highly predictable medical devices that offer consistent performance with minimal variation? The answer is process validation. Process validation is the framework around your medical device manufacturing process that ensures your device is inst…

Root cause investigation (RCI) is a problem-solving approach for gathering significant information and data regarding a particular problem or quality deviation. The primary goal of RCI is to identify the root cause of any existing or potential nonconformities and provide suitable solutions. The investigation process includes data collection, interviews, observations, and review. In the highly reg…

Medical device quality assurance can feel overwhelming, especially when you’re balancing product development, regulatory updates, and real-world patient safety. But the truth is, getting QA right is one of the most reliable ways to keep your product on the market and protect your reputation. Over the years, I’ve seen how small gaps in quality systems can snowball into costly delays, rejected subm…

What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplementary documents of EU GMP rules. The growing use of computerized systems in life sciences, alongside their intricate structures, has led to the necessi…

Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and controlled to the highest quality and safety levels. GMP standards cover all aspects of production, from starting materials, premises, quality assurance, te…