Compliance

Handling Customer Complaints in Pharmaceutical Industry
Introduction Customer complaints are critical events in the pharmaceutical industry, requiring prompt attention and resolution. Effective complaint handling ensures patient safety, maintains regulatory compliance, and upholds company reputation. In this blog, we’ll explore best practices for handling customer complaints in pharmaceutical QA. Key Principles Regulatory Requirements Complaint Handling Process Best ... Read More

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