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Frank's QA/QC lecture > QA/QC > Flashcards

QA/QC Flashcards

1
Q

QA provides evidence needed for the establishment of the qaulity of the product. TRUE OR FALSE?

A

TRUE

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2
Q

What is qaulity assurance?

A

In the pharmaceutical industry QA makes sure that final product is safe, efficacious and of good qaulity to GMP standards

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3
Q

What is quality control?

A

testing of the product, checks on the identity, stength, stability and purity of final product to BP specifications

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4
Q

Name what is involved in the GMP?

A
  • Processes
  • Training
  • Record keeping
  • Equipments
  • Materials
  • Procedures
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5
Q

Name some QC aspects?

A

QC is what the customers require

  • Maintainability
  • REliability
  • Safety
  • Inspections
  • Feedback
  • complaints
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6
Q

Is QC part of GMP?

A

Yes

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7
Q

Name some of QC GMP?

A
  • Testing
  • specifications
  • Record keeping
  • sampling
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8
Q

What are some of the questions asked in pharmaceutical analysis?

A
  • Presence of impurities
  • Right drug
  • Bioavailability
  • Stability - shelf life
  • Does it meet specifications
  • Biology
  • Pka partition coefficient, solubility
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9
Q

What are the QC of analytical methods?

A
  • Assay measurements for all procedures
  • Control of errors
  • Validation of analytical procedures
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10
Q

Why does QC need to be done right?

A
  • Regulations - GMP
  • Stasticical sampling is crucial
  • Consequence of bad batches
  • Consequences of poor analysis
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11
Q

What are the causes of errors in QC measurements?

A
  • Incorrect weighing and transfer
  • Measurement volume is incorrect
  • Improperly calibrated equipments
  • Failure to use blank
  • Inefficienr extraction of analyte
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12
Q

With accuracy and precision. one can make systematic and random errors. TRUE OR FALSE?

A

TRUE

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13
Q

Name tests done for validation?

A
  • Identification tests
  • Impurities: quantitative and limit tests
  • Quantitative tests of meoity
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14
Q

What is precision?

A

-The closeness in agreement between a series of measurements

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15
Q

What is precision usulaly expressed as?

A
  • Standard deviation
  • Variance
  • Coeffcient of variation of a series of measurements
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16
Q

What is repeatability and what is it also known as?

A

Is the precision obtained under the same conditions over a short time intervals
Intra assay precision

17
Q

What is intermediate precision?

A

Precison within laboratory variations

18
Q

What is reproducibility?

A

between laboratories

19
Q

What does SOP stand for?

A

standard operating procedure

20
Q

Systemic errors cannot be elimiated. TRUE OR FALSE?

A

FALSE

21
Q

True random errors cannot be eliminated completely. TRYE OR FALSE?

A

TRUE

22
Q

What are the 4 Qs for system suitability and describe each?

A
  • Design qaulitfication - fit for purpose?
  • Installation - are manufacturing claims correct
  • operational - does it work for analyst application
  • Performance - does it continue to perform to standards?
23
Q

What is an analytical blank?

A

-All materials apart from analyte

24
Q

What is calibration?

A

pre-set values under strict conditions

25
Q

What is limit detection, quantification?

A
  • limit detection - is the smallest amount that can be detected reliably
  • Limit qauntification - smallest amount that can be qauntified reliably
26
Q

What is range and linearity?

A
  • Range - limit between which acceptable precision and accurancy
  • Linearity - is the measurement of concntration or qauntity
27
Q

What is robustness and selectivity and sensitivity?

A
  • Robsuteness - resistance of precision and accuracy over small variations
  • Selectivity - measure analyte in the presence of other compounds
  • Sensitivity - Response to small change in analyte
28
Q

What are the advantages of using UV/VIS spectroscopy?

A
  • Cheap and easy to use
  • Provides information of the physico-chemical preoperties of the drug
  • Good precision for quantification
29
Q

What are the specific isues with UV/VIS spectroscopy?

A
  • No fingerprint region
  • Solvent choice is crucial
  • Sensitive to hcnages in pH and temperature
30
Q

What is absorptivity?

A

-How much specific wavelength a specific amount of molecule absorb

31
Q

What are the units of a?

A

Conc is g/L / cm-1 g-1 L

32
Q

What is hypothetical value?

A

-The absorbance that 1% would have if when in 1cm cell

33
Q

What is the equation of a accoring to beers law?

A

a= (1%,1cm)/10

34
Q

IR is qualitative fingerprint. TRUE OR FALSE?

A

TRUE

35
Q

NR is quantitative mixtures. TRUE OR FALSE?

A

TRUE

36
Q

IR AND NIR and vibrational spectroscopy. TRUE OR FALSE?

A

TRUE

37
Q

What are the positives and negative of NIR spectroscopy?

A

+ pentrates into material
+Rapid analysis of multicomponent samples

  • Extensive computerised methods
  • Expensive instruments
38
Q

What is atomic spectrophotometry and fluorenscence spectroscopy?

A

atomic spectrophotometry - detects emitted light

fluorenscence spectroscopy - measure emission at longer wavelengths

39
Q

What are the advantages and disadvantages of fluorenscence spectroscopy?

A

+Selective
+quantitative
+changes in complex molecules

  • Not all molecules are fluorescent
  • interference is possible

Frank's QA/QC lecture (4 decks)

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