by Dr. Yashashwini Reddy | Aug 10, 2025
Requirements and Implementation of Continuous Training in Pharmaceuticals Continuous training in the pharmaceutical industry is a regulatory, quality, and operational necessity to ensure that employees remain competent, compliant, and up-to-date with evolving...
by Dr. Yashashwini Reddy | Aug 10, 2025
Handling of Out of Calibration (OOC) Instruments and Equipment Definition Out of Calibration (OOC) refers to an instrument or equipment that, during calibration verification, fails to meet the specified acceptance criteria or shows results outside its defined...
by Dr. Yashashwini Reddy | Aug 9, 2025
Common Causes of Low Quality in Pharmaceuticals Ensuring high-quality pharmaceuticals is crucial to patient safety, regulatory compliance, and brand reputation. Low-quality products can lead to therapeutic failure, adverse reactions, and recalls. The following are...
by Dr. Yashashwini Reddy | Aug 9, 2025
Pharmaceutical Compliance and Product Quality 1. Pharmaceutical Compliance Definition:Adherence to all applicable laws, regulations, guidelines, and internal SOPs that govern pharmaceutical manufacturing, testing, storage, and distribution. Key Compliance Areas: GMP...
by Dr. Yashashwini Reddy | Aug 9, 2025
System Suitability in HPLC Analysis What is System Suitability? System Suitability Testing (SST) is a set of analytical checks performed before and during analysis to ensure that the HPLC system and method are capable of producing accurate, precise, and reproducible...
