Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -2
Question 1:
What is the primary aim of implementing a system according to the ICH Q10 guideline?
Answer 1:
The primary aim of implementing a system, is to ensure the delivery of products with quality attributes suitable to meet the needs of patients, healthcare professionals, regulatory authorities, and other internal and external customers.
Question 2:
How does the ICH Q10 guideline suggest maintaining a state of control in the pharmaceutical manufacturing process?
Answer 2:
The ICH Q10 guideline suggests maintaining a state of control in the pharmaceutical manufacturing process by developing and utilizing effective monitoring and control systems for process performance and product quality. These systems provide assurance of the continued suitability and capability of processes. Quality risk management is highlighted as a useful tool in identifying these monitoring and control systems.
Question 3:
What is the significance of continual improvement in the context of pharmaceutical quality?
Answer 3:
Continual improvement in pharmaceutical quality is significant as it enables the identification and implementation of appropriate product quality improvements, process enhancements, variability reduction, innovations, and pharmaceutical quality system enhancements. This continual improvement increases the ability to consistently meet quality needs.
Question 4:
How are knowledge management and quality risk management considered as enablers in the implementation of ICH Q10?
Answer 4:
Knowledge management and quality risk management are considered enablers in the implementation of ICH Q10 as they provide the means for science and risk-based decisions related to product quality. These enablers facilitate the achievement of objectives such as product quality improvements, process enhancements, and consistent fulfillment of quality needs.
Question 5:
In what ways does quality risk management contribute to both maintaining a state of control and facilitating continual improvement?
Answer 5:
Quality risk management contributes to maintaining a state of control by identifying effective monitoring and control systems for process performance and product quality. Additionally, it facilitates continual improvement by identifying and prioritizing areas for improvement, variability reduction, and innovations through risk-based decision-making.
Question 6:
How knowledge management defined and what is are its key components according to the ICH Q10?
Answer 6:
Knowledge management is defined as a systematic approach to acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components. Its key components include acquiring knowledge from various sources such as prior knowledge, pharmaceutical development studies, technology transfer activities, process validation studies, manufacturing experience, innovation, continual improvement, and change management activities.
Question 7:
Why is product and process knowledge management important throughout the product lifecycle?
Answer 7:
Product and process knowledge management is important throughout the product lifecycle because it ensures the continuous understanding and improvement of product quality and manufacturing processes. This knowledge, acquired through scientific approaches and various activities, enables informed decision-making and facilitates the optimization of processes from development through commercialization to product discontinuation.
Question 8:
How does quality risk management contribute to the effectiveness of a pharmaceutical quality system?
Answer 8:
Quality risk management is integral to an effective pharmaceutical quality system as it provides a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality. By facilitating the identification and mitigation of risks, quality risk management ensures the continual improvement of process performance and product quality throughout the product lifecycle, thereby enhancing the overall effectiveness of the quality system.
Question 9:
What are some examples of sources of knowledge mentioned in the ICH Q10?
Answer 9:
Some examples of sources of knowledge mentioned in the ICH Q10 include prior knowledge (public domain or internally documented), pharmaceutical development studies, technology transfer activities, process validation studies over the product lifecycle, manufacturing experience, innovation, continual improvement efforts, and change management activities.
Question 10:
Which ICH guideline provides principles and tools for quality risk management, and how does it contribute to pharmaceutical quality?
Answer 10:
ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. By offering a systematic approach to identifying, evaluating, and controlling risks, ICH Q9 facilitates the proactive management of potential risks to quality, thereby contributing to the enhancement of pharmaceutical quality throughout the product lifecycle.
