Compliance
How Do Regulated Companies Balance Quality and Compliance
First of all quality and compliance are related but distinct concepts. Quality refers to the degree to which a product or service meets or exceeds customer expectations. It’s about delivering value and ensuring satisfaction. Compliance, on the other hand, involves adhering to laws, regulations, standards, and guidelines set by external ... Read More
Inadequate Investigations: A Common Observation by the FDA
During cGMP inspections, one of the most commonly cited observations by the FDA is the inadequate investigation into deviations. Pharmaceutical companies must address this issue to maintain compliance and ensure patient safety. Here are some key points to keep in mind regarding deviation investigations in the pharmaceutical industry: Observation Highlight ... Read More