by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Requirements for Training in Pharmaceuticals The U.S. Food and Drug Administration (FDA), under 21 CFR Part 211 (cGMP for Finished Pharmaceuticals) and ICH Q10 Pharmaceutical Quality System, outlines clear expectations for employee training. 1. Training Program...
by Dr. Yashashwini Reddy | Aug 18, 2025
FDA Warning Letters for Cleaning Validation The FDA frequently issues Warning Letters to pharmaceutical manufacturers for deficiencies in cleaning validation programs, as inadequate cleaning can lead to cross-contamination, adulteration, and patient safety risks....
by Dr. Yashashwini Reddy | Apr 29, 2025
Pharmaceutical compliance plays a crucial role in ensuring the overall quality of medicinal products. Compliance in the pharmaceutical industry refers to adherence to regulations, laws, and guidelines set by governing bodies such as the U.S. Food and Drug...
by Dr. Yashashwini Reddy | Nov 5, 2024
Temperature Mapping in Pharmaceutical Storage Areas: Procedures and Best Practices Temperature mapping is a foundational process in pharmaceutical storage to ensure products are kept within prescribed temperature ranges. Proper mapping procedures, supported by...
by Dr. Yashashwini Reddy | Oct 27, 2024
The Critical Role of Critical Quality Attributes (CQAs) in the Pharmaceutical Industry Introduction In the pharmaceutical industry, ensuring product quality and patient safety is paramount. Critical Quality Attributes (CQAs) are essential to maintaining these...
