QA/QC Flashcards
QA provides evidence needed for the establishment of the qaulity of the product. TRUE OR FALSE?
TRUE
What is qaulity assurance?
In the pharmaceutical industry QA makes sure that final product is safe, efficacious and of good qaulity to GMP standards
What is quality control?
testing of the product, checks on the identity, stength, stability and purity of final product to BP specifications
Name what is involved in the GMP?
- Processes
- Training
- Record keeping
- Equipments
- Materials
- Procedures
Name some QC aspects?
QC is what the customers require
- Maintainability
- REliability
- Safety
- Inspections
- Feedback
- complaints
Is QC part of GMP?
Yes
Name some of QC GMP?
- Testing
- specifications
- Record keeping
- sampling
What are some of the questions asked in pharmaceutical analysis?
- Presence of impurities
- Right drug
- Bioavailability
- Stability - shelf life
- Does it meet specifications
- Biology
- Pka partition coefficient, solubility
What are the QC of analytical methods?
- Assay measurements for all procedures
- Control of errors
- Validation of analytical procedures
Why does QC need to be done right?
- Regulations - GMP
- Stasticical sampling is crucial
- Consequence of bad batches
- Consequences of poor analysis
What are the causes of errors in QC measurements?
- Incorrect weighing and transfer
- Measurement volume is incorrect
- Improperly calibrated equipments
- Failure to use blank
- Inefficienr extraction of analyte
With accuracy and precision. one can make systematic and random errors. TRUE OR FALSE?
TRUE
Name tests done for validation?
- Identification tests
- Impurities: quantitative and limit tests
- Quantitative tests of meoity
What is precision?
-The closeness in agreement between a series of measurements
What is precision usulaly expressed as?
- Standard deviation
- Variance
- Coeffcient of variation of a series of measurements
What is repeatability and what is it also known as?
Is the precision obtained under the same conditions over a short time intervals
Intra assay precision
What is intermediate precision?
Precison within laboratory variations
What is reproducibility?
between laboratories
What does SOP stand for?
standard operating procedure
Systemic errors cannot be elimiated. TRUE OR FALSE?
FALSE
True random errors cannot be eliminated completely. TRYE OR FALSE?
TRUE
What are the 4 Qs for system suitability and describe each?
- 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?
What is an analytical blank?
-All materials apart from analyte
What is calibration?
pre-set values under strict conditions
What is limit detection, quantification?
- limit detection - is the smallest amount that can be detected reliably
- Limit qauntification - smallest amount that can be qauntified reliably
What is range and linearity?
- Range - limit between which acceptable precision and accurancy
- Linearity - is the measurement of concntration or qauntity
What is robustness and selectivity and sensitivity?
- 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
What are the advantages of using UV/VIS spectroscopy?
- Cheap and easy to use
- Provides information of the physico-chemical preoperties of the drug
- Good precision for quantification
What are the specific isues with UV/VIS spectroscopy?
- No fingerprint region
- Solvent choice is crucial
- Sensitive to hcnages in pH and temperature
What is absorptivity?
-How much specific wavelength a specific amount of molecule absorb
What are the units of a?
Conc is g/L / cm-1 g-1 L
What is hypothetical value?
-The absorbance that 1% would have if when in 1cm cell
What is the equation of a accoring to beers law?
a= (1%,1cm)/10
IR is qualitative fingerprint. TRUE OR FALSE?
TRUE
NR is quantitative mixtures. TRUE OR FALSE?
TRUE
IR AND NIR and vibrational spectroscopy. TRUE OR FALSE?
TRUE
What are the positives and negative of NIR spectroscopy?
+ pentrates into material
+Rapid analysis of multicomponent samples
- Extensive computerised methods
- Expensive instruments
What is atomic spectrophotometry and fluorenscence spectroscopy?
atomic spectrophotometry - detects emitted light
fluorenscence spectroscopy - measure emission at longer wavelengths
What are the advantages and disadvantages of fluorenscence spectroscopy?
+Selective
+quantitative
+changes in complex molecules
- Not all molecules are fluorescent
- interference is possible
