This comprehensive training program provides an in-depth exploration of the ICH Q7 guideline, the international standard for Good Manufacturing Practice (GMP) in the manufacture of Active Pharmaceutical Ingredients (APIs). Designed for professionals across the pharmaceutical supply chain, the curriculum systematically covers the entire API lifecycle, from the critical definition of an “API Starting Material” and quality management principles to the detailed requirements for facilities, equipment, documentation, and production controls. The program delves into specialized areas such as process validation, change control, handling of non-conforming materials, and the unique GMP considerations for contract manufacturing, clinical trial APIs, and products derived from cell culture or fermentation. Through detailed modules, practical exercises, and comprehensive questionnaires, participants will gain the knowledge and skills necessary to ensure APIs are consistently produced and controlled to meet the quality standards required for their safe and effective use in human medicines.
This training program is based exclusively on the principles and requirements of the following international guideline and its associated references:
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. The program also references related ICH guidelines that form an interconnected framework with Q7, including:
The program also aligns with foundational GMP principles in major regulatory frameworks, such as 21 CFR Parts 210/211 (US FDA) and EudraLex Volume 4 (EU GMP), which incorporate ICH Q7 as the core standard for API manufacturing.
This training program is designed for all personnel working in or supporting GMP-regulated API manufacturing environments, including:
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
