General Biotechnology

Question 1

Research and Development

Answer 1

Works to identify new or improved products or processes

Question 2

Manufacturing

Answer 2

Participates in the production of commercial quantities of a product

Question 3

Quality Control

Answer 3

Conducts testing on raw materials, in-process samples, and finished products.

Question 4

Proteomics

Answer 4

The study of the entire set of proteins of a cell or organism

Question 5

Step 1 of product production

Answer 5

Quality Control tests, and approves or rejects raw materials, following test records

Question 6

Step 2 of product production

Answer 6

Manufacturing produces the product following a batch record

Question 7

Step 3 of product production

Answer 7

Quality Control tests the final product following test records

Question 8

Step 4 of product production

Answer 8

Quality Assurance approves or rejects the final product based on final product specifications

Question 9

Phase 1 clinical trial

Answer 9

Phase with healthy volunteers or people with the disease/condition. The primary focus is on studying safety parameters of the drug.

Question 10

Phase 2 clinical trial

Answer 10

Phase with volunteers who have the disease or condition. The primary focus is efficacy and determining side effects.

Question 11

Phase 3 clinical trial

Answer 11

Phase with volunteers who have the disease or condition. The primary focus is a broad scale study of the drug’s efficacy, and monitoring side effects.

Question 12

What is a controlled document that contains step-by-step instructions on how to perform a routine activity within a company?

Answer 12

Standard Operating Procedure

Question 13

What is a controlled document that contains step-by-step instructions on how to manufacture a product, including spaces for capturing information specific to the task?

Answer 13

Batch Record

Question 14

What is heat stable DNA polymerase used for?

Answer 14

PCR reactions

Question 15

Protease

Answer 15

Degrading protein