Podcast
Questions and Answers
Standard in the pharmaceutical industry aims to ensure quality, safety, and efficacy of the ____________.
Standard in the pharmaceutical industry aims to ensure quality, safety, and efficacy of the ____________.
False
The availability of various framework and guidelines is essential for ensuring ____________.
The availability of various framework and guidelines is essential for ensuring ____________.
False
CGMP stands for Current Good Manufacturing ____________.
CGMP stands for Current Good Manufacturing ____________.
False
The FDA stands for Food and Drug ____________.
The FDA stands for Food and Drug ____________.
Signup and view all the answers
The EMA stands for European Medicines ____________.
The EMA stands for European Medicines ____________.
Signup and view all the answers
The FDA is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, USA food supply, cosmetics, and products that emit radiation. True or False?
The FDA is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, USA food supply, cosmetics, and products that emit radiation. True or False?
Signup and view all the answers
European GMP relates to European Commission Directive which describes principles and guidelines of GMP in respect to medicinal products for human use and investigational medicinal products for human use. True or False?
European GMP relates to European Commission Directive which describes principles and guidelines of GMP in respect to medicinal products for human use and investigational medicinal products for human use. True or False?
Signup and view all the answers
The Clean Room is used in laboratory work and in the production of precision parts for electronic or aerospace equipment. True or False?
The Clean Room is used in laboratory work and in the production of precision parts for electronic or aerospace equipment. True or False?
Signup and view all the answers
ISO has 126 member countries that follow its regulations. True or False?
ISO has 126 member countries that follow its regulations. True or False?
Signup and view all the answers
Grade A, Grade B, Grade C, and Grade D are used to define different levels of clean room contamination. True or False?
Grade A, Grade B, Grade C, and Grade D are used to define different levels of clean room contamination. True or False?
Signup and view all the answers
What does the FDA provide in addition to assuring safety, efficacy, and security of various products?
What does the FDA provide in addition to assuring safety, efficacy, and security of various products?
Signup and view all the answers
Which agency oversees European Good Manufacturing Practices (GMP)?
Which agency oversees European Good Manufacturing Practices (GMP)?
Signup and view all the answers
What is the primary function of a clean room in the pharmaceutical industry?
What is the primary function of a clean room in the pharmaceutical industry?
Signup and view all the answers
What are the different levels of clean room contamination defined by?
What are the different levels of clean room contamination defined by?
Signup and view all the answers
What is ISO primarily known for in the context of regulations?
What is ISO primarily known for in the context of regulations?
Signup and view all the answers
Which statement best describes the purpose of international standards in the pharmaceutical industry?
Which statement best describes the purpose of international standards in the pharmaceutical industry?
Signup and view all the answers
What is the primary focus of European GMP regulations?
What is the primary focus of European GMP regulations?
Signup and view all the answers
What is the responsibility of the Food and Drug Administration (FDA) in the USA?
What is the responsibility of the Food and Drug Administration (FDA) in the USA?
Signup and view all the answers
What does cGMP stand for in the pharmaceutical industry?
What does cGMP stand for in the pharmaceutical industry?
Signup and view all the answers
What is the main purpose of a clean room in the pharmaceutical industry?
What is the main purpose of a clean room in the pharmaceutical industry?
Signup and view all the answers
