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Quality by Design (QbD) Fundamentals Quiz

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Quality by Design (QbD) Fundamentals Quiz

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Questions and Answers

What is the focus of the pharmaceutical industry?

Providing quality drug products for human use

What has the pharmaceutical industry been facing challenges in delivering?

Quality drug products

According to the news article in The Wall Street Journal, what was reported about the pharmaceutical industry's manufacturing standards?

Lag far behind the potato chips and laundry soap makers

Where is the Department of Pharmaceutics located at SPER, Jamia Hamdard?

New Delhi, India Signup and view all the answers

Which university hosts the Shalom Institute of Health and Allied Sciences?

Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS) Signup and view all the answers

What are the major issues pertaining to the poor quality of drug products?

Variable starting materials, lack of manufacturing process automation and control, and improper understanding of product and process parameters. Signup and view all the answers

When was the concept of Quality by Design (QbD) first adopted by the pharmaceutical industry?

In 2004, when USFDA took initiative for improving the standards of pharmaceutical manufacturing. Signup and view all the answers

Who formulated the concept of Quality by Design (QbD) in the early 1970s?

J.M. Juran, an American Engineer. Signup and view all the answers

What does the International Conference on Harmonization (ICH) institute with regard to Quality by Design (QbD)?

ICH instituted various regulatory guidances (Q8, Q9, and Q10) and set forth the concept of quality by design (QbD) as a holistic approach. Signup and view all the answers

In 2005, what did USFDA emphasize through the guidance for industry titled 'Quality Systems Approach to Pharmaceutical CGMP Regulations'?

It emphasized critical attributes related to the chemistry, manufacturing, and control, and their relevance to safety and effectiveness of the drug product. Signup and view all the answers