by Dr. Yashashwini Reddy | Aug 11, 2025
Calibration of Hardness Tester in Pharmaceuticals 1. Introduction Tablet hardness testers are used in pharmaceutical QC labs to measure the crushing strength of tablets, which affects packaging, transport, and dissolution. Regular calibration ensures reliable and...
by Dr. Yashashwini Reddy | Aug 10, 2025
QC Audit Checklist 1. General Documentation & Records SOPs for all QC activities (latest approved versions, controlled copies). Records of training, competency assessments, and analyst qualification. QC logbooks (instrument usage, calibration, maintenance). Change...
by Dr. Yashashwini Reddy | Aug 8, 2025
Resolving API Impurity Issues in Drug Development 1. Understanding the Issue In drug development, impurities in the Active Pharmaceutical Ingredient (API) can arise from: Starting materials or intermediates (process-related impurities) By-products from synthesis steps...
by Dr. Yashashwini Reddy | Jun 30, 2025
🧪 Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development 🔹 Introduction Good Clinical Practice (GCP) is an international ethical and scientific quality standard for...
by Dr. Yashashwini Reddy | Jun 28, 2025
⚠️ Challenges Faced in Clinical Research 🔹 1. Participant Recruitment and Retention Difficulty in finding eligible and willing volunteers. High dropout rates affect trial integrity. Lack of diversity in participant populations. 🔹 2. Regulatory and...
