Training
How frequently should you check your training status?
Everyday.
What is a biofilm?
A film/layer of bacteria.
What does the "H" in HPLC stand for?
Heavy
What does SOP sand for?
Standard Operating Procedure.
T or F: A verifier must complete verification by confirming or authenticating someone elses' work through review or inspection?
True
What does the first "A" in ALCOA stand for?
Attributable
Where does Endotoxin come from?
Gram-Negative bacteria’s outer membrane
What is the purpose of a control sample in analytical testing?
To verify the accuracy and precision of the method.
What does GMP stand for?
Good Manufacturing Practice.
T or F: Under no circumstances may GMP data be recorded before the corresponding step is performed?
True.
What does the "D" in DMAIC stand for?
Define
What is the contact time of sterahol?
1 minute
What is the name of the device used to determine pH?
pH meter
What does OOS stand for?
Out of Specification.
T of F: Email can record GMP data?
False
What is the purpose of Pfizer’s Training Waiver Form
The form is used to document justified exceptions to training requirements.
How many Raw Material intakes do we average in Andover every year?
350
To verify the accuracy and precision of the method?
Antigen or antibody
What is a SMART goal?
Specific, measurable achievable, realistic, and time bound.
During what parts of the drug development life cycle are stability studies required?
All.
What is the digital documentation system used by pharm-sci quality to digitally track and access batch records?
GDMS
How many active raw material parts are there?
192
Which analytical technique is most commonly used to determine protein concentration?
Spectroscopy
What does "SME" mean in relation to the experienced person with knowledge of a specific subject that is under study?
Subject Matter Expert.
What happens if a stability annual batch fails testing during the study?
Assay failures or OOS results must be investigated by the lab and reported to the applicable health authorities.