ICH Q7: API Guidelines
Overview
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
The ICH Q7 guideline provides details of Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API). It is a guideline adopted globally for applying GMP to APIs (drug substances) and is crucial to ensure consistent quality and safety throughout the API manufacturing process. This guideline was developed at a time when there were several regional guidelines and is important since it is a globally agreed consensus between multiple regulatory agencies and industry representatives on how GMP should be applied to API manufacturing.
Course Modules/Learning Objectives
- Q7 Fundamentals
- Importance and Relevance of ICH
- Q&A Document and API Manufacturing Starting Material
- Q7 chapters
Interactive Course includes:
- Immersive Videos
- Engaging graphics
- Reference materials and links to regulatory information
- Assessments to measure your comprehension
- The ability to start and stop at any time, beginning where you left off
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.