SOPs
Quality Lab Manual
Equipment
Process
Data Integrity
100
Name an instruction from SOP-015 Good Documentation Practices
1. how to make appropriate corrections to GMP Documents
2. recording dates in correct format
3. recording late entries
100
What does QMS stand for?
Quality Management System
100
What must be included on every notebook page
A signature and a date
100
What is it called when a 2nd Analyst must review data/recording before 1st analyst proceeds
"Witnessing"
100
How many significant figures are there in the number 12.0034
6
200
What is SOP-004 Laboratory Investigations about?
SOP that you must follow if you get an out of specification result in your testing.
200
What is the definition of "GMPs"
The minimum requirements for the methods, facilities, and controls in manufacturing, processing, and packing of a drug product (including testing).
200
How can you tell if an instrument is calibrated?
Calibration Sticker
200
When analyzing a sample on the UV/Vis Spectrophotometer - How many times should you rinse the cell with the intended solvent?
3-5 times
(SOP-068)
200
What is definition of "Attributable"
"Data generated or collected is traceable back to the individual who generated the information."
(SOP-015)
300
Name 2 things required on an Equipment Log
1. Identification of SOPs or methods followed (if applicable)
2. Date of entry/usage
3. Initials or signature of personnel performing the operation, or the
4. EZ Labs employee acknowledging receipt of a service
5. Cleaning
6. Equipment condition
300
Name 2 Responsibilities of Lab Personnel
300
Can you use equipment labeled "Out of Service" for R&D Only?
No (SOP-040)
300
Name 3 Items that should be on a Chemical Container (from EZ Labs)
300
What is 25.2 x 4 (using Significant Figures)
101 (3 sig figs and rounded)
SOP-018
400
Who is responsible for your training (3)
1) You
2) Supervisor
3) QA
400
GMP Refresher Training is required how often?
Annually at a minimum
(SOP-003 Training Program)
400
What must the Milli-Q operating parameters be when using the system? (1 of 2)
400
What do you do if an auditor or inspector asks you a question for which you don't know the answer?
If you cannot answer the question, then refer the question to the appropriate person. If the person is not available, tell the Auditor that you will provide the answer to the Auditor later
400
Round 6.752 to 2 significant figures
6.8
500
Name 3 types of Standards
1. Primary Reference
2. Secondary Reference
3. Working Standard
4. Organic Impurity Reference Standard
5. Non Quantitative Reference Standard
(SOP-060)
500
Name 1 element of EZ Labs Code of Conduct
1) Arrive on time and ready to work.
2) Show respect for others at all times, even if you disagree with them.
3) Hold yourself accountable for your actions.
4) Follow and enforce company policies.
5) Complete your work to the best of your abilities.
6) Respect personal and company property.
500
When performing Equipment Qualifications, are the protocols approved prior to qualification, after qualification or both?
Both prior to and after executing
500
If you are testing a stability timepoint equal to or less than 3 months, how many days do you have to test from pull date?
5 working days from pull date
(SOP-014)
500
How many characters must your password be?
Can you select "Save Password" when authenticating applications?
At least 8 (POL-003)
NO