ICH 8a Flashcards
(23 cards)
What does ICH stand for?
International Council for Harmonisation
What is the main purpose of ICH guidelines?
To ensure that the quality, safety, and efficacy of pharmaceuticals are consistent across different countries.
True or False: ICH 8 guidelines specifically address clinical trial protocols.
False
What is the focus of ICH Q8 guidelines?
Pharmaceutical Development
Fill in the blank: ICH Q8 emphasizes the importance of __________ in the pharmaceutical development process.
Quality by Design
What does Quality by Design (QbD) aim to achieve?
To ensure that products are designed to meet quality standards from the outset.
Which ICH guideline is related to the concept of ‘design space’?
ICH Q8
What is a ‘design space’ according to ICH Q8?
The multidimensional space of input variables and process parameters that have been demonstrated to provide assurance of quality.
What is the role of risk assessment in ICH Q8?
To identify and mitigate potential risks to product quality.
What does ICH Q8 say about process validation?
It should be based on a thorough understanding of the process and product.
Which document provides guidance on the control of drug product quality?
ICH Q8
What is the recommended approach for process optimization in ICH Q8?
Use of scientific principles and data to guide decisions.
Short Answer: How does ICH Q8 relate to regulatory submissions?
It provides a framework for including quality considerations in regulatory submissions.
Which ICH guideline is focused on the development of biopharmaceuticals?
ICH Q8
Fill in the blank: ICH Q8 encourages the use of __________ to monitor and control the manufacturing process.
Real-time data
What is the importance of a ‘control strategy’ in ICH Q8?
It outlines the methods and controls used to ensure product quality.
True or False: ICH Q8 allows for flexibility in pharmaceutical development processes.
True
What does ICH Q8 suggest regarding continuous improvement?
It encourages ongoing evaluation and enhancement of processes.
Short Answer: What is the significance of ‘product lifecycle’ in ICH Q8?
It acknowledges that product quality considerations should be maintained throughout the product’s lifecycle.
What is the relationship between ICH Q8 and ICH Q9?
ICH Q9 provides guidance on quality risk management that complements the principles of ICH Q8.
True or False: ICH Q8 requires extensive documentation for every phase of drug development.
False
What is the ultimate goal of implementing ICH Q8 guidelines?
To enhance patient safety and product efficacy.
Which ICH guideline emphasizes the importance of understanding the pharmaceutical process?
ICH Q8
