Process Validation and Drug Quality Quiz

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Questions and Answers

What is the basic principle of quality assurance in the context of process validation?

Quality, safety, and efficacy are designed or built into the product

How does FDA use the term 'Process Validation'?

To refer to the life cycle of validation, from process design to routine manufacture

What does effective process validation contribute significantly to?

Assuring drug quality

What does EMA use the term 'Process Validation' to represent?

The life cycle of the product Signup and view all the answers

What does each step of a manufacturing process aim to assure?

That the finished product meets all quality attributes including specifications Signup and view all the answers

What is the definition of process validation?

Defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Signup and view all the answers

What is the principle of quality assurance in relation to drug production?

The principle is that a drug should be produced that is fit for its intended use. Signup and view all the answers

How does FDA use the term 'Process Validation'?

To refer to the life cycle of validation, from process design to routine manufacture. Signup and view all the answers

What does the term 'Qualification and Validation' refer to according to EMA?

It is used to define processes applicable to facilities, services, and equipment. Signup and view all the answers

What are the conditions that the principle of quality assurance incorporates?

Quality, safety, and efficacy are designed or built into the product. Quality cannot be adequately assured merely by in-process and finished-product inspection or testing. Each step of a manufacturing process is controlled to assure that the finished product meets all quality attributes including specifications. Signup and view all the answers