This webinar will cover ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API). Attendees will gain a deeper understanding of the importance of GMPs for APIs, apply these principles in their current roles in order to better manage quality, make improvements, solve problems and make decisions.
Why Should You Attend:
ICH Q7, (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) will be the primary document used to define Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs). In order define GMP requirements for APIs throughout product lifecycle however, the ICH Q7 Working Group noted that portions of ICH Q10 (Pharmaceutical Quality System), ICH Q11, (Development and Manufacture of Drug Substances), ICH Q8 (R2), PART II (Pharmaceutical Development) and ICH Q9, (Quality Risk Management) be reviewed as well.Learning Objectives:
- Understand the roles of quality management, quality personnel and production in ensuring GMP manufacture of the APIs under an appropriate system for managing quality, as required by regulatory authorities worldwide.
- Firms involved in contract manufacturing of APIs will better understand requirements that must be met in order to satisfy their obligations to the customer to use GMPs under an appropriate system for managing quality. In addition, contract manufacturers will remain within compliance.
- Understand and apply requirements for GMPs for APIs, as defined by ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
- Understand the level of GMPs required for APIs during each stage of the product lifecycle.
Areas Covered in the Webinar:
- ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- Applicable portions of the following documents will be discussed as well, in order to define GMPs for APIs during each stage of the product lifecycle per Working Group for ICH Q7:
- ICH Q10 (Pharmaceutical Quality System),
- ICH Q11 (Development and Manufacture of Drug Substances),
- ICH Q8(R2), PART II (Pharmaceutical Development) and
- ICH Q9 (Quality Risk Management)
Who Will Benefit:
- Quality management
- Quality personnel/Quality control unit personnel
- Regulatory affairs professionals
- Production personnel
- Quality auditors
- Compliance professionals
- Quality engineers
Course Provider
Stephanie Cooke,
