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GMP quiz

Joan Benson 20 preguntas 3.118 visitas Actualizado el 17 ene 2017

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Preguntas del test (20)

  1. 1Who is responsible for Quality and GMP in the University of Manchester cleanroom facility?
    1. AQuality Assurance Manager
    2. BQualified Person (QP)
    3. CProfessor Sue Kimber
    4. DProduction Manager
    5. EEveryone who works in this area
  2. 2What is the abbreviation IMP used for?
    1. AInner Membrane Protein
    2. BInosine Monophosphate
    3. CInvestigational Medicinal Product
  3. 3How do you ascertain that a piece of equipment in the cleanroom is ready for use?
    1. AReview its cleaning record
    2. BReview its calibration record/status
    3. CReview its validation record/status
    4. DReview its performance qualification
    5. EAll of the above
  4. 4The definition of GMP is ‘a quality system (a) - - - - - - - that products are (b) - - - - - - - - manufactured to a (c) - - - - - - - appropriate to their intended use’.
    1. A(a) assuring, (b) correctly, (c) system
    2. B(a) ensuring, (b) consistently, (c) quality
    3. C(a) checking, (b) properly, (c) scheme
  5. 5The drug which made a large contribution to the necessity to set up the Medicines Act was Thalidomide. True or false?
    1. AVerdadero
    2. BFalso
  6. 6The primary concern of the MHRA and other regulators is to ensure .......
    1. Athat they visit every pharmaceutical manufacturer once a year.
    2. Bthat foreign drugs do not enter the UK market.
    3. Cpatient safety.
    4. Dthat they thoroughly check all manufacturing and cleaning records.
  7. 7Quality Risk Management is described in ....
    1. AICH guideline Q9
    2. BICH guideline Q2
    3. CICH guideline Q8
  8. 8If you make an error when entering information on to a GMP document, what should you do?
    1. AUse Tippex to erase the entry, then write on top of it once dry.
    2. BUse pencil for all entries so you can easily rub it out and re-write it.
    3. CUse a single line to cross through the original entry, then enter the correct information as close as possible to the original entry. Sign and date the amendment with a brief explanation for the change.
    4. DUse a line of crosses so the original entry can no longer be seen, then enter the correct information as close as possible to the original entry, sign and date this change.
  9. 9What should happen to rejected materials?
    1. AThey should be put in a suitable waste bin as soon as possible.
    2. BThey should be labelled as rejected and stored with other materials.
    3. CThey should be clearly labelled as rejected and stored separately in a restricted area.
    4. DThey should be saved and used as material in experimental work.
  10. 10For GMP outsourcing, what documentation must be in place between a contract giver and contract acceptor, e.g. for contract manufacturing or analysis?
    1. AAll the information necessary to manufacture or test in accordance with the Marketing Authorisation, CTA or IND.
    2. BA fully signed contract between both parties.
    3. CA technical/quality agreement.
    4. DA list of responsibilities.
    5. EAll of the above.

Información

Descripción
A quiz to test GMP knowledge
Idioma
English
Visitas
3.118
Historial
Creado el 5 ene 2015 · actualizado el 17 ene 2017
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