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Quiz

MO10 Drug Quality and Shelf Life

Mer Scott 11 Fragen

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Fragen in diesem Quiz (11)

  1. 1Quality of medicines is important especially, because medicines can be [blank_start]hazardous[blank_end], their quality is [blank_start]easily[blank_end] compromised, and people take them in [blank_start]good faith[blank_end] without being able to assess the quality by themselves.
    1. Ahazardous
    2. Beasily
    3. Cgood faith
  2. 2Which of these would NOT be a potential hazard of substandard medicines?
    1. ATherapeutic failure
    2. BExacerbation of disease
    3. CDeath
    4. DUndermined confidence in the health system
    5. EWasted resources
    6. FTherapeutic success
  3. 3Quality assurance covers all matters that [blank_start]collectively[blank_end] influence the [blank_start]quality[blank_end] of a medicine. Encompasses design and manufacturing.
    Quality in design revolves around [blank_start]research and development[blank_end] to make a drug safe and efficacious.
    Quality in manufacture revolves around [blank_start]distribution, storage and dispensing[blank_end]. Quality in manufacturing must be [blank_start]consistent[blank_end] and safety and efficacy must be [blank_start]maintained[blank_end] throughout storage until drug is used.
    1. Acollectively
    2. Bquality
    3. Cresearch and development
    4. Ddistribution, storage and dispensing
    5. Econsistent
    6. Fmaintained
  4. 4The main issue with only testing finished products to assure quality is that it is [blank_start]reactive[blank_end] and not [blank_start]preventive[blank_end], and cannot address quality issues during [blank_start]distribution and storage[blank_end]. It is [blank_start]wasteful[blank_end] in terms of time and money if a batch is bad.
    1. Areactive
    2. Bpreventive
    3. Cdistribution and storage
    4. Dwasteful
  5. 5Choose all the options that may be issues for quality during manufacture.
    1. APackaging system
    2. BRaw materials
    3. CLabelling
    4. DPremises and equipment
    5. EGeographical location
  6. 6NZ has a Code of [blank_start]Good Manufacturing Process[blank_end] (GMP) for the Manufacturing and Distribution of Therapeutic Goods. It has 3 parts.
    Part 1 of the code encompasses the manufacture of pharmaceutical products and [blank_start]raw materials[blank_end]. It has components on personnel, premises and equipment, production, contract manufacturing and analysis, complaints and product recall, self inspection, documentation, and [blank_start]quality control[blank_end].
    1. AGood Manufacturing Practice
    2. Braw materials
    3. Cquality control
  7. 7Match the 4 types of GMP documentation to their description.

    [blank_start]Standard Operating Procedure (SOP)[blank_end] - describes a routine procedure of general use which is not specific to one product.
    [blank_start]Manufacturing instructions[blank_end] - instructions for a specific product.
    [blank_start]Records[blank_end] - provides a history of each batch of product.
    [blank_start]Specifications[blank_end] - the quality attribute requirements that materials and products must conform to.
    1. AStandard Operating Procedure (SOP)
    2. BManufacturing instructions
    3. CRecords
    4. DSpecifications
  8. 8Choose the incorrect statement about GMP specifications.
    1. AThey are based on critical quality attributes.
    2. BThey are defined in pharmacopoeias or medicine dossiers.
    3. CThey are standards of quality for a finished drug product, but not the raw materials and intermediates.
  9. 9Quality control is the checking of critical attributes throughout the manufacturing process.
    1. ARichtig
    2. BFalsch
  10. 10GMP and QC do not promote process [blank_start]understanding[blank_end] or optimization. QC testing is slow and [blank_start]resource[blank_end] intensive. Process Analytical Technology (PAT) is a method of assessing critical quality attributes [blank_start]during[blank_end] the manufacturing process by performing [blank_start]in line analysis[blank_end](spectroscopy). [blank_start]Computer feedback[blank_end] could automatically optimise the process.
    1. Aunderstanding
    2. Bresource
    3. Cduring
    4. Din line analysis
    5. EComputer feedback

Informationen

Beschreibung
PHCY211 (Molecules) Quiz am MO10 Drug Quality and Shelf Life, erstellt von Mer Scott am 09/04/2018.
Sprache
English
Aufrufe
11
Schlagwörter
phcy211molecules
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