GxP Refresher Training ICH Q8, Q9 and Q10

This eLearning provides an overview of ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management (QRM) and Q10 Pharmaceutical Quality System (PQS). It summarises the key principles and benefits that accrue with the effective and collective implementation of ICH Q8,9 and 10.

Each section concludes with a short quiz to test your knowledge and following successful completion of the course, you will be issued with a certificate.

The course provides an introduction, followed by a look at ICH Q10, 9 and 8 in turn.

• ICHQ10 – the module provides a definition of a Pharmaceutical Quality System (PQS) and its’ primary objective. It describes the inputs, processes and outputs of an effective PQS and the trend towards a quality culture, closing out with MHRA and FDA deficiency data and warning letter trends
• ICH Q9 - Quality Risk Management (QRM) is a systematic process for the assessment, control, communication, and review of risks to product quality. The module provides an overview of a typical QRM process, along with some risk management tools such as risk ranking and filtering, HACCP and FMEA, closing out with industry trends and regulatory observations
• ICH Q8 – the module provides an overview of the aim of Pharmaceutical Development and the term “Quality by Design”. It displays the various stages of product/process development and the link to ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”. It explains the key concepts of Quality Target Product Profile, Critical Quality Attributes, Critical Process Parameters, Design Space and Control Strategy, providing examples of each. It concludes with industry trends and benefits, along with examples of regulatory observations.