Q4 W5

Question 1

Completed documentation should be used, reviewed, and approved by relevant departments.

False
True

Answer 1

False

Question 2

This diagram consists of all the information a trained operator needs to achieve batch-to-batch quality

Production Flow Diagram
Venn Diagram
Quantitative Diagram
Circle Diagram
Tree Diagram

Answer 2

Production Flow Diagram

Question 3

What is an additional part of the coating process that was mentioned in the Advil video, however wasn’t shown in the solid dosage flow chart?

Polishing
Binding
Dusting
Coloring
Subcoating

Answer 3

Polishing

Question 4

__________________ is a document of written procedures that obtains updated FDA guidelines that must be followed.

Standard Operating Procedure
Master Batch Record
Executive Batch Record
Master Validation Plan
Batch Record

Answer 4

Standard Operating Procedure

Question 5

Bioburden, dissolution and disintegration, variation, and capsule weight all have procedures and specification controls for?

Sampling and Testing
Acceptance and Rejection Criteria
Sterility Controls
Laboratory Controls
Manufacturing Controls

Answer 5

Sampling and Testing

Question 6

Batch records and Master batch records are similar to…

Recipes
FDA guidelines
SOPs
In-Process Control Tests
Checkpoints

Answer 6

Recipes

Question 7

Rejected in-process materials shall be identified and controlled under a quarantine system designed to prevent use according to:

211.89
211.188
211.186
211.184
211.194

Answer 7

211.89

Question 8

The process to patient pipeline is a process of ensuring that QUIPS is built into the process throughout the process by ensuring that your drug product is made the same each time and will always meet quality specifications.

True
False

Answer 8

True

Question 9

__________________ are derived from previous acceptable process average and process variability estimates​.

Answer 9

Acceptance criteria

Question 10

Explain why the saying “If it’s not documented, it didn’t happen” is important.

Answer 10

Sometimes people remember things wrong or might not be telling the truth. It is better to assume things that are not documented did not occur because there could be an issue in the future. For example, someone forgets to add a certain ingredient to a drug. They don’t remember if they put the ingredient or not but they decide to document it as if they have. A customer might buy that drug and possibly not receive any benefits or may even be harmed by it. And because there was a mistake in the documentation, it will be very difficult to find the issue.