by Dr. Yashashwini Reddy | Jun 9, 2025
Validation of Compressed Air frame 1. Introduction Importance of compressed air in pharmaceutical manufacturing. Regulatory expectations (e.g., EU GMP Annex 1, ISO 8573, WHO guidelines). Role of compressed air in cleanroom environments, product...
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 28, 2024
Out of Specifications (OOS) in Pharmaceuticals Out of Specification (OOS) results occur when the test results of a pharmaceutical product fall outside the predefined acceptance criteria specified in regulatory guidelines or quality standards. These deviations are...
by Dr. Yashashwini Reddy | Oct 24, 2024
Good Laboratory Practices (GLP) in the pharmaceutical industry are a set of internationally recognized standards that ensure the quality, consistency, and integrity of non-clinical studies. These practices are critical for ensuring that the data generated during drug...
by Dr. Yashashwini Reddy | Sep 28, 2024
“Top 7 Granulation Interview Questions in Pharma and How to Answer Them” What factors influence particle size distribution in the granulation process? The particle size distribution during granulation can be controlled by adjusting several parameters,...
