AVCN 2 - Unit 3

Học trực tuyến tại quizlet.com/_4jhr9d

1. Audit An internal __________ involves inspection and 21. non- If any __________ is observed during the audit, the
validation of operational methods, compliance department will be informed so they can take
procedures, equipment to ensure corrective action.
functionality, accuracy and validity.
22. Odour An __________ is a distinctive unpleasant smell.
2. Auditor A/An __________ inspects and verifies the safety
23. Overshoes __________ are shoe covers used to reduce foot
procedures in the lab.
borne contamination and help maintain a
3. CAPA __________ stands for Corrective sterile environment.
Action/Preventive Action. It is a part of the
24. Preventive __________ prevents occurrence of errors
overall Quality Management System (QMS)
action
required for GMP
25. Product Even a product that has been marketed for
4. Checklist To ensure that laboratory workers are asked
recall years might have to be taken off the market in
certain questions about safety procedures,
a __________ if serious adverse reactions occur.
auditors use a __________.
26. Product The reason for interim testing, or __________, is to
5. Contaminated __________ are no longer pure and acceptable
sampling check the quality of pharmaceutical products.
drugs for sale or public use and, therefore, must be
returned to the manufacturer, or destroyed. 27. Quality __________ involves all manufacturing processes
assurance in GMP which make sure the goods produced
6. Corrective __________ prevents recurrence of errors
are kept at high standards.
action
28. Quality __________ involves interim and product sampling
7. Endpoint At the end of every stage of a product's
control procedures, which are carried out to check
testing manufacturing process, __________ is done to
product quality.
maintain quality standards.
29. Quality __________ (QMS) is a formalized system that
8. Eye bath ___________ is a/an apparatus to wash the eyes
Management documents processes, procedures, and
after exposure to chemical contamination.
System responsibilities for achieving quality policies
9. Finding Any observation or _______ noted by the and objectives.
auditors is categorized as either major,
30. Safety __________ make sure that the health and well-
minor, or critical.
procedures being of laboratory workers are guaranteed.
10. Fire blanket A/an __________ is a safety device consists of a
31. Standard _________ are a set of written instructions to
sheet of a fire retardant material which is
operating maintain performance and results. They are
placed over a fire in order to extinguish it.
procedures the basis of good QA and QC system.
11. GAP __________ stands for Good Auditing Practice. (SOPs)
12. Gas mask A/an __________ is a device that you wear over 32. Traceability The documentation required for all research
your face in order to protect yourself from processes and development steps ensures the
poisonous gases. __________ of a drug.
13. GCP __________ stands for Good Clinical Practice. 33. up-to-date Scientists often read journals and go to
international conferences, because they need
14. GDP __________ stands for Good Documentation
to stay _________ in their scientific fields.
Practice
34. Validation Manufacturing processes and procedures
15. Genotoxic __________ is a chemical that damages cellular
must go through periodic __________ to guarantee
substance DNA, resulting in mutations or cancer.
that they are still of an acceptable standard.
16. GLP __________ stands for Good Laboratory Practice.
17. GMP __________ stands for Good Manufacturing
Practice.
18. GRP __________ stands for Good Research Practice
19. GSP __________ stands for Good Safety Practice
20. Holistic A __________ looks at all aspects of a
approach pharmaceutical company together to make
sure that the entire process meets high
industry standards.