1. GMPs only apply to new drugs: True or False 2. Which of the following supports generic drug...

1. GMPs only apply to new drugs: True or False

2. Which of the following supports generic drug approvals? A. Premarket Notification B. Abbreviated NDA C.New Drug Application D.None of the above

21 CFR Part 210 is one of two sections of the regualtions pertaining to GMPs. True or False

he following are types of validation related to Good Manufacturing Practices and other regulations (select all that apply): A Bioequivalent B. Process C. Informed Consent D. Computer System E. All of the Above

Expert Solution

1. GMPs only apply to new drugs: False

GMP strands for Goods manufacturing practice. It is a quality control system which ensures all pharmaceutical products are well tested before come to the market and it is safe to use. Some food products, diagnostics also have GMP.

2.

B. Abbreviated NDA support generic drug approvals.

Generic drug application termed as Abbreviated new drug application . Generic drugs is a drug that is made up of a same chemical substances of a patented drug. Clinical trials is not necessary for generic drug . So it is termed as Abbreviated.

3.

21 CFR Part 210 is one of two sections of the regualtions pertaining to GMPs __ true.

Part 210 is for current good manufacturing practice in manufacturing, processing ,packing of drugs.

Part 211 is about Current GMP for finished pharmaceutical.

All of the above are the types of validation related to Good Manufacturing Practice and other regulations.

gladiator answered 2 years ago

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