Remember the game show You Don't Know Jack? In the same spirit, we will post a quick multiple choice quiz every week, prepared by an expert on the topic, to see how well you know a timely, important, or widely misunderstood subject.
Be among the first five to post the right answers on the message board below, and, depending on where you're based, you could win a custom PharmaEvolution mug or a $10 Starbucks gift card. The following week, we'll reveal the correct answers via the message board.
This week's quiz will tackle one of pharma's most discussed but least understood three-letter acronyms: PAT (and, no, we won't expand it for you).
Thanks for the NIR spectroscopist and pharma PAT expert Emil Ciurczak for sending us the questions. And remember: No Googling the answers or other forms of cheating.
So, do you know PAT?
In what year was the PAT Guidance released by the US FDA?
Who was the driving force in getting the Guidance written and approved?
a. Ajaz Hussain
b. Janet Woodcock
c. Moheb Nasr
d. Saddam Hussein
The basic tenets of PAT are:
a. Measure, archive, report
b. Measure, understand, control
c. Measure, compare to cGMPs, report
d. Measure, pass/fail, package/destroy
True or False: Design Space is first mentioned in the PAT Guidance.
Technologies mentioned in the PAT Guidance are:
a. Near-Infrared only
b. Near-Infrared and Raman
c. NIR, Raman, and Infrared
d. No techniques were specified
If a QbD program is initiated, PAT (for that product) should be continued:
b. 1 year
c. 6 months
d. 3 months
The differences between current practices of GMP and the PAT program are:
a. PAT considers every lot a validation lot
b. Processes are measured in real-time
c. There is no set limit to the number of samples taken
d. The tests in PAT are non-destructive
e. All of the above
The biggest difficulty that QA departments had with the PAT Guidance is:
a. It specifies “best scientific judgment” instead of set numbers of tests
b. They were not included in the fact-finding portion of the Guidance writing
c. There is no mention of cGMPs in the Guidance
d. There is no number of validation lots required
The acronym PAT stands for:
a. Process Analysis Technologies
b. Process Analytical Technology
c. Process Analysis Technology
d. Production Analytical Technology
Answer True or False for each of the following:
a. PAT is required by the FDA
b. QbD is required by the FDA
c. QbR (Question based Review) is required by the FDA
Under PAT, A process is generally considered well understood when which of the following conditions are met? (Pick all that apply.)
a. Critical sources of variability are identified and explained
b. All possible degradation products are isolated and characterized
c. Variability is managed by the process
d. The COGS (cost of goods sold) is optimized
e. Product quality attributes can be accurately and reliably predicted over the design space established
f. All units produced are within USP release standards
Design space is established for which parameters? (Pick all that apply.)
a. Raw materials used
b. API synthesis routes
c. Process parameters
e. Environmental factors
f. Documentation for data storage
Re: Darts in a dark room Thanks so much for daring to take Emil Ciurczak's PAT quiz. Four responses were wrong. I will send the correct responses privately, in the hope that more people dare to take this quiz. Please feel free to comment on your experiences or thoughts on PAT, and any disagreements you may have re: definitions in the quiz, etc. Thanks again!