GMP Jeopardy

Calculations

100

Round to the nearest hundredth:0.3489

What is 0.35

200

API net weight is 1250.0 g and your total weight is 1343.2 g. Calculate your tare weight

What is 93.2g

300

Calculate the mix time in minutes? 

Mix Start time 16:40 21 Aug 2023 

Mix End time 06:36 22 Aug 2023

836 min

400

There is 27kgs of solution in your tank your flow rate is 90grams per minute

What is 5 hours

500

Your solvent ratio is 90% acetone and 10% water your total target solvent weight is 156.8kg. Calculate your target weight for water

What is 15.7 kg

GDocP

100

You record manufacturing start time at 1:32 pm make the correction

Line out the time, input 13:32 with correction stating incorrect time format

200

You record the incorrect lot # on the MBR, which error code do you use?

What is TE?

300

You were out of town on Monday, Tuesday  morning you go to end the solution mix time with your co-worker. The first thing you do is ...

Get trained on the record

400

Identify the acronym CAPA

What is Corrective and Preventative Actions

500

Make the fix: you create a footnote in the MBR the next day realize you forgot your initials/date.

Sign the footnote for the current date. Create a new footnote stating operator omitted initials and date at time of execution, initial and date. 

New phone who dis

100

You need AC which department do you contact

Who is QA?

200

You ran out of type 2 water who would you reach out to 

Kyle Smith/ Materials Specialist

300

This group must be notified of any deviations

What is Quality Assurance

400

The manufacturing floor cannot maintain room differential who do you contact

Alex Mattick

500

You find a piece of zip tie in your drum of api during solution prep, who do you contact

Operations management, QA

Operations

100

To witness, supervise, or check another individual's observation and calculation

What is verify

200

The date of manufacture typically begins when you...

Add API to the solution tank 

300

What logbooks are opened for execution of a logbook

Equipment and room 

400

Identify the SOP for the SD-180

SOP-131

500

What is the SOP for the operating the SD-720

What is SOP-226

Safety

100

The first thing you do when disassembling a process tank

What is depressurize tanks?

200

When should you check clamp tightness on the spray dryer 

Prior to any operation of the spray dryer

300

PPE you wear for breaking a pressurized line with acetone

face shield, sleeve covers, second pair of gloves

400

Label api waste water drum

non hazardous pharmaceutical waste

500

Before breaking down the SD-720 for clean where do you applied a lock out tag out lock

What is the HMI/Nitrogen