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Quality Control Interview Questions For Pharma
Quality Control Interview Questions For Pharma
Quality Control Interview Questions For Pharma
What Is GLP?
GLP is good laboratory Practices & is defined as,
A set of standard regulations or guidelines which are used to generate reproducible
results which can be validated and replicated in the experimental conditions.
Or
A system that is used to deal with Organizational processes & Conditions under which
non-clinical health & environmental safety studies are planned, conducted, monitored,
recorded, archived & reported.
Or
Good Laboratory Practices is a set of regulations that are used to ensure consistency,
quality, safety, reliability & integrity of chemicals during non-clinical & laboratory testing.
What Is SISPQ?
SISPQ represents,
S = Safety
I = Integrity
S = Strength
P = Purity
Q = Quality
Or
A working standard is a standard that is prepared & qualified against a pharmacopoeial
reference standard.
Name of compound
Physical Description
LOD/MC
Assay or purity on as is basis.
Date of preparation
Vial number
Retest Date
Storage Conditions
What Is an Incident?
Any unplanned activity which results in non-compliance to the designated systems or
procedures at any stage of testing or storage of drug products due to system failure,
breakdown, or manual error.
What Is Deviation?
A deviation is an undesired event that is different from standard or approved
procedures, processes, instructions, or specifications.
What Is OOS?
OOS is Out Of Specification & a commonly used term in pharmaceutical industries
defined as,
When the test results are different from the specification mentioned in SOPs or Official
compendia.
What Is OOT?
OTT is Out Of Trend & defined as,
The test results obtained may be within the specified limits but show a difference from
historical values or results.
What Is Calibration?
Calibration is the performed activity that demonstrates that the results produced by a
device or an instrument are within the defined range as compared to the standards.
What Is Corrective & Preventive Action?
An action that is performed to eliminate the cause of a present deviation, problem, or
incident to prevent its Recurrence is known as Corrective Action.
An action that is performed to eliminate the cause of the potential deviation, problem, or
incident to prevent its Recurrence is known as Preventive Action.
Also Read
Quick Review of 40 Dosage Forms
Disintegration Test?
The disintegration test is the determination of the time in which a tablet breaks into
small fragments which pass through sieve number 10 leaving behind no hard mass.
1. Basket Apparatus
2. Paddle Apparatus
3. Reciprocating Cylinder
4. Flow Through Cell
5. Paddle Over Disc
6. Rotating Cylinder
7. Reciprocating Holder
Stage 1 (S1)
Stage 2 (S2)
Stage 3 (S3)
What Is pH?
A negative log of hydrogen ion concentration is known as pH.
What is pka?
pka value indicates the strength of an acid.The pka value is negative log of acid
dissociation constant. The lower value of pka shows that the acid is stronger.
Define Acid.
The substances which release hydrogen ions i.e protons are known as acids.
Define Base
The base is a substance that has the ability to accepts hydrogen ions.
What Is Molarity?
Molarity is defined as,
The number of moles of a substance per liter of a solution is known as Molarity.
Molarity is also known as Molar Concentration.
It is expressed by Capital M.
Example
1 M solution means it contains one mole of solute per liter of solution.
What Is Molality?
Molality is defined as,
The number of moles of a solute per kilogram of solvent is known as Molality.
It is expressed by a small m.
Example
1 m solution means it contains one mole of solute per liter of solution.
What Is Normality?
The number of gram equivalent of solute present in one liter of solution is known as
Normality.
It is represented by N.
What is Sonication?
Sonication is a process in which undissolved particles are made soluble by degassing.
Also Read
GMP vs cGMP and 21 CFR.
What Is Titration?
Titration is the most commonly used (quantitative analysis) laboratory method where the
concentration of the unknown solution is measured by reacting it with the slow addition
of a solution of known concentration. The endpoint is indicated by color change. It is
also known as volumetric titration or Titrimetry.
What Is Titrate?
The solution of known concentration in titration is known as Titrate.
What is Analyte?
The solution of unknown concentration in titration is known as Analyte.
Acid-Base Titration
Complexometric Titration
Redox Titration
Precipitation Titration
Water Content
Water content is only the quantity of water present in a drug product.
Water content is determined by the Karl Fischer titration method where we get value
only for water.
Volumetric
Coulometric
Iodine
Sulfur Dioxide
Base (Methanol)
Pyridine/Imidazole
Detector Electrode
Anode Chamber
Cathode Chamber
Rotor
Electrode
Drying Tube
Drying Pipe
Kf Reagent
Injection Port
Magnetic Stirrer
Also Read
Why we Use only 70% IPA.
What Is Chromatography?
Chromatography is a separation technique in which components of a sample are
distributed between two phases one is known as the stationary phase & other is the
mobile phase.
Types Of Chromatography?
Following are the types of chromatography,
Paper Chromatography
Thin-Layer Chromatography
Column Chromatography
Gas Chromatography
Liquid Chromatography
What Is a Chromatogram?
The graph or plot obtained after the completion of the separation process in
chromatography is known as a chromatogram
What Is HPLC?
HPLC is High-Pressure Liquid Chromatography Or High-Performance Liquid
Chromatography.
Components Of HPLC?
The following are the main components of HPLC,
Abbreviations Of HPLC?
Vm = Hold Up Volume
tM = Hold Up Time
VR1 = Retention Volume Peak 1
tR1 = Retention Time Peak 1
VR2 =Retention Volume Peak 2
tR2 =Retention Time Peak 2
Wh =Peak width at half height
Wi =Peak width at an inflection point
h = Height Of Peak
h/2 = Half the Height of the Peak
tR = Retention Time
tT=Total Mobile phase Time
What Is Retention Time?
The time spent by a component in a column or with a stationary phase after sample
injection is known as Retention Time.
Helium
Nitrogen
Hydrogen
PDA Detector
UV Detector
Light Scattering Detector
Conductivity Detector
Fluorescence Detector
Refractive Index Detector
What Is a Polarimeter?
Polarimeter is an instrument that is used to measure the polarization of light for finding
the effect of a substance on rotating the plane of polarization of light.
What is Enantiomer?
The mirror images of a compound are known as enantiomers.
What is Dextrorotatory?
A compound that has the property to rotate the plane polarized light to right or clockwise
is known as dextrorotatory.
What is levorotatory?
A compound that has the property to rotate the plane polarized light to left or
anticlockwise is known as levorotatory.
What Is Spectroscopy?
Spectroscopy is the study of spectra produced by matter due to the absorption or
emission of light & other radiations.
What Is Cuvette?
Cuvette is a small,sided, clear container that is used for placing samples in a
spectrophotometer.
Optical Glass
UV Quartz
IR Quartz
Sapphire
Light Source
Monochromator
Sample Holder
Detector
Recorder
Halogen Lamp
Deuterium Lamp
Xenon Lamp
Low-Pressure Mercury Lamp
What Is FTIR?
FTIR is Fourier Transform Infrared spectroscopy & is used for the identification of
substances.