Biomedical Engineering Reference
In-Depth Information
abc Pharmaceutical comPany
SOP No.:
Issued on:
Revision No.:
Initiator name:
Attachment 2
SOP TRAINING QUESTIONNAIRE
Trainee:
ID:
Trainer:
ID:
Subject:
SOP No.:
Multiple Choice: Mark infront of the right answer.
1. SOP QAS
is applicable to
a.
Standard operating procedures
b.
Standard test methods
c.
Registration documents
d.
QC certificate of analysis
2. All master superseded SOPs shall be
a.
Destroyed
b.
Copied and distributed to all departments
c.
Kept by the production manager
d.
Stamped “void” in red and archived in QA
3. All systems SOPs shall be reviewed
a.
Once every 12 months (1 year) or as and when required
b.
Every 2 years
c.
Every 5 years
d.
Never
4. All equipment and fixed operation-related SOP shall be
a.
Reviewed every 3 months
b.
Reviewed every 3 years
c.
Reviewed every 60 months (5 years)
d.
Reviewed every 5 years or as and when required
5. All SOPs shall be reviewed within
a.
2 months after the review date
b.
3 months after the review date
c.
30 days from the review date
d.
All of the above
6. SOPs for distribution are
a.
Copied from the master SOP
b.
Copied, stamped “uncontrolled,” documented in the SOP distribution record register
c.
None of the above
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