Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -1
Question 1:
What is the main focus of the Pharmaceutical Quality System (PQS) outlined in the ICH Q10 guideline?
Answer 1:
The main focus of the Pharmaceutical Quality System (PQS) described in the ICH Q10 guideline is to establish an effective quality management system within the pharmaceutical industry.
Question 2:
How does the Pharmaceutical Quality System (PQS) defined in the ICH Q10 guideline relate to other ICH guidelines and existing regulatory requirements?
Answer 2:
The PQS outlined in the ICH Q10 guideline is based on International Standards Organization (ISO) quality concepts, incorporates relevant Good Manufacturing Practice (GMP) regulations, and complements other ICH guidelines such as ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”.
Question 3:
What is the scope of the Pharmaceutical Quality System (PQS) as defined by the ICH Q10 guideline?
Answer 3:
The Pharmaceutical Quality System (PQS) outlined in the ICH Q10 guideline applies to the systems supporting the development and manufacture of pharmaceutical drug substances (API) and drug products, including biotechnology and biological products, throughout the product lifecycle.
Question 4:
How should the elements of ICH Q10 be applied across different stages of the product lifecycle?
Answer 4:
The elements of ICH Q10 should be applied in a manner that is appropriate and proportionate to each stage of the product lifecycle, recognizing the differences among, and the different goals of each stage.
Question 5:
What are the technical activities included in the product lifecycle according to the ICH Q10 guideline?
Answer 5:
The technical activities included in the product lifecycle, as defined by the ICH Q10 guideline, encompass pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. These activities involve various stages such as pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation.
Question 6:
What is the foundational relationship between ICH Q10 and Regional GMP Requirements, ISO Standards, and ICH Q7?
Answer 7:
The ICH Q10 guideline is built upon the foundation provided by Regional GMP requirements, the ICH Q7 Guideline (which is the “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”), and ISO quality management system guidelines. These standards collectively provide the framework for ICH Q10.
Question 7:
How does ICH Q10 complement Good Manufacturing Practice (GMP) regulations?
Answer 7:
ICH Q10 augments GMPs by detailing specific quality system elements and management responsibilities. It provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. Additionally, it is intended to be used alongside regional GMP requirements.
Question 8:
What is the purpose of describing quality system elements and management responsibilities in ICH Q10?
Answer 8:
The quality system elements and management responsibilities outlined in ICH Q10 are intended to encourage the use of science and risk-based approaches at each stage of the product lifecycle. This approach promotes continual improvement across the entire lifecycle of the product.
Question 9:
How the effectiveness of the pharmaceutical quality system is typically evaluated?
Answer 9:
The effectiveness of the pharmaceutical quality system is typically evaluated during a regulatory inspection at the manufacturing site. This evaluation considers factors such as the level of product and process understanding, the results of quality risk management, and compliance with regulatory requirements.
Question 10:
What are the three main objectives of implementing the Q10 model as stated in the ICH Q10 guideline?
Answer 10:
The three main objectives of implementing the Q10 model, are to complement or enhance regional GMP requirements. These objectives aim to improve product and process understanding, enhance quality risk management, and promote continual improvement throughout the product lifecycle.
