A Quality Management System (QMS) is a structured framework that establishes and controls an organization’s processes and procedures to ensure the delivery of high-quality products…

In today’s competitive business landscape, ensuring high-quality products and services is crucial for the success of any organization. To achieve this, businesses are turning to…

The Quality by Design (QbD) approach is gaining more significance during the drug development process. This comprehensive and proactive approach aims to ensure quality is…

Quality is paramount in any business. It signifies trustworthiness, reliability, and consistency. Without a defined measure of quality, products or services can become inconsistent, which…

Medical devices encompass a wide range of products designed to diagnose, monitor, treat, or alleviate medical conditions. The regulatory landscape for medical devices varies globally…

In the pharmaceutical industry, maintaining precise and accurate measurements is critical to ensuring pharmaceutical products’ safety, efficacy, and quality. The master calibration schedule is crucial…

ISO 13485 in Medical Device An ISO 13485 consultant is a qualified professional who can help medical device manufacturers implement and maintain an ISO 13485…

What is International Regulatory Framework (IRF)? The IRF or International Recognition Framework is a new initiative that aims to streamline the regulatory approval process for…

Internal auditing is a crucial component of the pharmaceutical industry that is responsible for ensuring compliance with regulations, maintaining product quality, and managing risks associated…