Q3

Question 1

The purpose of a sight glass is to confirm if the solid has dissolved into the liquid and should be assessible.

True
False

Answer 1

True

Question 2

Per the 1st Takeda link, Confirmation and analysis of target protein lot are performed by who before it’s release?

Molecular Scientists
Quality Group
Manufacturing Dept
Quality Assurance
Sterility Group

Answer 2

Quality Group

Question 3

When referencing CFRs, if you wanted the specifics on biologics which Part will you find more on regulations pertaining to such?

Part 25
Part 210
Part 800
Part 600
Part 820

Answer 3

Part 600

Question 4

Subpart C of 21CFR Part 211 refer to:

Drugs
Holding and Distribution
Buildings and Facilities
Equipment
Organization and Personnel

Answer 4

Buildings and Facilities

Question 5

Per the 3rd Takeda Video, IG vials were filled in an ___________environment.

Cleanroom
Aseptic
Sterile
Closed
Lab

Answer 5

Aseptic

Question 6

Which of these are not true regarding equipment?

Calibrated and Inspected Instruments
Human Interface
Active Air Monitoring
Validated Computer Functions
Instrument Back-ups

Answer 6

Active Air Monitoring

Question 7

_____________________ is used to measure the pressure difference between two adjacent cleanrooms

HVAC System
Thermocouple
Air Particle Counter
Dataloggers
Magnehelic Gauge

Answer 7

Magnehelic Gauge

Question 8

Which of these ISO grades are the least strict in regards to cleanliness?

ISO 5
ISO 9
ISO 1
ISO 7
ISO 3

Answer 8

ISO 9

Question 9

Sanitation and maintainance of facilities are to be performed by _________________ according to written and scheduled procedures.

Answer 9

trained personnel

Question 10

What are the three zones in the site layout Map and give a short description of each.

Answer 10

The three zones are clean, packing, and controlled. Look at lectures for more details.