QSEM and Q-Series Guidelines

Screenshot 2025 10 18 131516 QSEM and Q-Series Guidelines

1. Introduction to ICH and QSEM The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) plays an indispensable role in the global pharmaceutical landscape. Formed in 1990, the ICH emerged from the necessity to bring regulatory authorities and pharmaceutical industry stakeholders together to harmonize the scientific and technical aspects of … Read more

Manufacture of Drugs for Test, Examination, and Analysis

Screenshot 2024 07 27 173900 Manufacture of Drugs for Test, Examination, and Analysis

The manufacture of drugs for test, examination, and analysis is a critical aspect of pharmaceutical research and development. This process involves the production of small quantities of drugs that are not intended for commercial sale but are used to evaluate their safety, efficacy, and quality. Such activities are essential in various stages of drug development, … Read more