QA/QC

Question 1

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

Answer 1

TRUE

Question 2

What is qaulity assurance?

Answer 2

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

Question 3

What is quality control?

Answer 3

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

Question 4

Name what is involved in the GMP?

Answer 4

• Processes
• Training
• Record keeping
• Equipments
• Materials
• Procedures

Question 5

Name some QC aspects?

Answer 5

QC is what the customers require

• Maintainability
• REliability
• Safety
• Inspections
• Feedback
• complaints

Question 6

Is QC part of GMP?

Answer 6

Yes

Question 7

Name some of QC GMP?

Answer 7

• Testing
• specifications
• Record keeping
• sampling

Question 8

What are some of the questions asked in pharmaceutical analysis?

Answer 8

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

Question 9

What are the QC of analytical methods?

Answer 9

• Assay measurements for all procedures
• Control of errors
• Validation of analytical procedures

Question 10

Why does QC need to be done right?

Answer 10

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

Question 11

What are the causes of errors in QC measurements?

Answer 11

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

Question 12

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

Answer 12

TRUE

Question 13

Name tests done for validation?

Answer 13

• Identification tests
• Impurities: quantitative and limit tests
• Quantitative tests of meoity

Question 14

What is precision?

Answer 14

-The closeness in agreement between a series of measurements

Question 15

What is precision usulaly expressed as?

Answer 15

• Standard deviation
• Variance
• Coeffcient of variation of a series of measurements

Question 16

What is repeatability and what is it also known as?

Answer 16

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

Question 17

What is intermediate precision?

Answer 17

Precison within laboratory variations

Question 18

What is reproducibility?

Answer 18

between laboratories

Question 19

What does SOP stand for?

Answer 19

standard operating procedure

Question 20

Systemic errors cannot be elimiated. TRUE OR FALSE?

Answer 20

FALSE

Question 21

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

Answer 21

TRUE

Question 22

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

Answer 22

• 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?

Question 23

What is an analytical blank?

Answer 23

-All materials apart from analyte

Question 24

What is calibration?

Answer 24

pre-set values under strict conditions

Question 25

What is limit detection, quantification?

Answer 25

- limit detection - is the smallest amount that can be detected reliably - Limit qauntification - smallest amount that can be qauntified reliably

Question 26

What is range and linearity?

Answer 26

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

Question 27

What is robustness and selectivity and sensitivity?

Answer 27

- 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

Question 28

What are the advantages of using UV/VIS spectroscopy?

Answer 28

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

Question 29

What are the specific isues with UV/VIS spectroscopy?

Answer 29

- No fingerprint region - Solvent choice is crucial - Sensitive to hcnages in pH and temperature

Question 30

What is absorptivity?

Answer 30

-How much specific wavelength a specific amount of molecule absorb

Question 31

What are the units of a?

Answer 31

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

Question 32

What is hypothetical value?

Answer 32

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

Question 33

What is the equation of a accoring to beers law?

Answer 33

a= (1%,1cm)/10

Question 34

IR is qualitative fingerprint. TRUE OR FALSE?

Answer 34

TRUE

Question 35

NR is quantitative mixtures. TRUE OR FALSE?

Answer 35

TRUE

Question 36

IR AND NIR and vibrational spectroscopy. TRUE OR FALSE?

Answer 36

TRUE

Question 37

What are the positives and negative of NIR spectroscopy?

Answer 37

+ pentrates into material +Rapid analysis of multicomponent samples - Extensive computerised methods - Expensive instruments

Question 38

What is atomic spectrophotometry and fluorenscence spectroscopy?

Answer 38

atomic spectrophotometry - detects emitted light | fluorenscence spectroscopy - measure emission at longer wavelengths

Question 39

What are the advantages and disadvantages of fluorenscence spectroscopy?

Answer 39

+Selective +quantitative +changes in complex molecules - Not all molecules are fluorescent - interference is possible