by Dr. Yashashwini Reddy | Apr 28, 2025
“Factors Contributing to Out-of-Specification Outcomes” refers to the various reasons or elements that can cause a product, process, or system to fall outside the defined limits or specifications. These factors are critical in industries such as...
by Dr. Yashashwini Reddy | Nov 28, 2024
Basic Guidelines for Process Validation in Tablet Manufacturing Process validation is a critical component of pharmaceutical manufacturing that ensures each batch of tablets meets quality, safety, and efficacy standards. The following guidelines outline the...
by Dr. Yashashwini Reddy | Nov 26, 2024
Top Interview Questions for Experienced Candidates in Formulation R&D (Oral Solid Dosage) 1. Can you explain the pre-formulation studies conducted before developing an OSD? Answer: Pre-formulation studies involve evaluating the physicochemical properties of a drug...
by Dr. Yashashwini Reddy | Oct 22, 2024
Quality by Design (QbD) in Pharmaceuticals: Enhancing Drug Development and Manufacturing In the pharmaceutical industry, ensuring product quality is crucial to patient safety and regulatory compliance. Quality by Design (QbD) is a systematic approach to drug...
by Dr. Yashashwini Reddy | Oct 18, 2024
Process Research and Development (R&D) in Pharmaceuticals The Process Research and Development (Process R&D) department in the pharmaceutical industry is responsible for developing, refining, and optimizing the methods used to manufacture drugs. This critical...
