Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -6
Question 1:
What are the four elements of the pharmaceutical quality system described in the ICH Q10?
Answer 1:
The four elements of the pharmaceutical quality system described in the ICH Q10 are:
- Process performance and product quality monitoring system
- Corrective action and preventive action (CAPA) system
- Change management system
- Management review of process performance and product quality
Question 2:
What is the intent of the Q10 model regarding these PQS elements?
Answer 2:
The intent of the Q10 model is to enhance these elements to promote the lifecycle approach to product quality. While these elements might be required in part under regional GMP regulations, the Q10 model aims to improve and integrate them to ensure a comprehensive approach to quality management throughout the product lifecycle.
Question 3:
How should PQS elements be applied across the product lifecycle stages?
Answer 3:
PQS elements should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of, each stage. This ensures that the implementation of these elements is tailored to the specific needs and requirements of each stage of product development and manufacturing.
Question 4:
What is encouraged for companies throughout the product lifecycle according to the ICH Q10?
Answer 4:
Throughout the product lifecycle, companies are encouraged to evaluate opportunities for innovative approaches to improve product quality. This suggests that companies should continuously seek new and improved methods to enhance their quality systems and processes.
Question 5:
What follows each PQS element description in the ICH Q10?
Answer 5:
Following each PQS element description in the ICH Q10 is a table of example applications of the element to the stages of the pharmaceutical lifecycle. These tables provide practical examples of how each element can be applied across different stages of product development and manufacturing.
Question 6:
What are the goals described for the pharmaceutical development stage?
Answer 6:
The goal of pharmaceutical development activities is to design a product and its manufacturing process to consistently deliver the intended performance and meet the needs of patients, healthcare professionals, regulatory authorities, and internal customers’ requirements.
Question 7:
How are technology transfer activities defined in terms of their goal?
Answer 7:
The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.
Question 8:
What are the primary goals of commercial manufacturing according to the ICH Q10?
Answer 8:
The goals of manufacturing activities include achieving product realization, establishing and maintaining a state of control, and facilitating continual improvement. The pharmaceutical quality system should assure that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.
Question 9:
What is the objective of product discontinuation activities?
Answer 9:
The goal of product discontinuation activities is to manage the terminal stage of the product lifecycle effectively. This involves using a predefined approach to manage activities such as retention of documentation and samples, continued product assessment (e.g., complaint handling and stability), and reporting in accordance with regulatory requirements.
Question 10:
How do the results of exploratory and clinical development studies contribute to pharmaceutical development?
Answer 10:
The results of exploratory and clinical development studies serve as inputs to pharmaceutical development. These studies provide valuable information and insights that contribute to the design of the product and its manufacturing process, aiming to consistently deliver the intended performance and meet various requirements.
