by Dr. Yashashwini Reddy | Oct 9, 2025
Analytical procedure development is the process of designing and optimizing methods to accurately and precisely measure the active pharmaceutical ingredient (API), excipients, impurities, and degradation products in a drug substance or drug product. The goal is to...
by Dr. Yashashwini Reddy | Oct 9, 2025
Good Manufacturing Practices (GMP) for APIs are essential to ensure that the Active Pharmaceutical Ingredients produced are of consistent quality and meet their intended use requirements. These guidelines are mainly described in ICH Q7 – Good Manufacturing Practice...
by Dr. Yashashwini Reddy | Oct 9, 2025
In pharmaceuticals, specifications are a set of standards, tests, analytical procedures, and acceptance criteria that define the quality requirements for materials and products. They ensure that every product consistently meets its intended safety, efficacy, and...
by Dr. Yashashwini Reddy | Oct 8, 2025
🧭 Quality Guidelines – Overview Quality Guidelines are internationally harmonized standards developed mainly by the International Council for Harmonisation (ICH) and other regulatory authorities (like FDA, EMA, WHO, CDSCO).They help ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 22, 2025
WHO Guidance on Cross-Contamination Definition:Cross-contamination is the unintended presence of one product (or its residues, microbes, cleaning agents, etc.) in another product. Prevention Measures (as per WHO TRS, GMP guidelines): Dedicated facilities or equipment...
