GMP, GLP, and Ethical Considerations

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Questions and Answers

Which of the following is NOT a primary focus of Good Manufacturing Practice (GMP)?

Ensuring product safety
Adhering to regulatory guidelines
Maintaining consistent product quality
Optimizing production costs (correct)

The OECD principles of GLP primarily aim to ensure what?

Standardization of laboratory equipment
Reduction of animal testing
Quality and validity of data related to safety studies (correct)
Promotion of international trade

What is the significance of 'hygienic engineering' in the context of GMP?

It involves designing facilities and equipment to minimize contamination risks. (correct)
It focuses on reducing energy consumption in manufacturing plants.
It aims to lower the cost of cleaning and sanitization processes.
It prioritizes aesthetic appeal of the manufacturing environment.

Which ethical consideration is most relevant to stem cell research in the biopharmaceutical industry?

Obtaining informed consent for stem cell donation and use (D) Signup and view all the answers

In the context of ethical manufacturing, what does 'transparency' primarily refer to?

Openly communicating manufacturing processes and data to stakeholders (C) Signup and view all the answers

What is the primary goal of applying Quality by Design (QBD) principles in biotechnology product development?

To ensure consistent product quality and performance (D) Signup and view all the answers

In Design of Experiments (DOE), what is a 'factor'?

A variable that is intentionally changed to observe its effect (B) Signup and view all the answers

Which of the following is a key element of QBD related to understanding the product?

Establishing a detailed understanding of the product's critical quality attributes (CQAs) (D) Signup and view all the answers

How can Design of Experiments (DOE) be effectively applied in analytical method development?

To optimize method parameters for robustness and reliability (A) Signup and view all the answers

What is the relationship between GMP and QBD in biotechnology product manufacturing?

GMP provides the foundational requirements, while QBD enhances process understanding and control (C) Signup and view all the answers

Flashcards

Good Manufacturing Practice (GMP)

A set of regulations, standards, and guidelines designed to ensure that products are consistently produced and controlled according to quality standards.

Good Laboratory Practice (GLP)

A quality system established for research laboratories to ensure the consistency, reliability, reproducibility, quality, and integrity of non-clinical studies.

Hygienic Engineering

Standards for the design, construction, and operation of equipment, buildings, and systems used in manufacturing processes to minimize contamination and ensure product safety and quality.

Ethical Manufacturing

The application of moral principles to manufacturing processes, ensuring products are safe, effective, and beneficial to society while minimizing harm.