1)What
do u mean by MACO & NOEL
MACO-max allowable carry over
NOEL – no observed effect leve;
Both of them are set limits for cleaning
validation
2) composition of c18 column
Octa di acyl silane
3) how to select columns
for specific products
Column selection based on
a)
Polarity
b)
Electrical charge
c)
Molecular size
Normal phase is recommended for water sensitive compounds/geo metric
isomers/cis-trans isomers/chiral compounds/class separations
Reverse phase for
non polar /polar/ionizable/non ionizable molecules
Gel permeation for large size compounds like polmers
Ion exchange for resins
4) define
validation/validation protocol/validation master plan
Validation protocol :- it is written plan describing
the process to be validated ,including production equipment & how how
validation to be conducted
Validation master plan : it was also called as VMP which is one of
important document in GMP regulated industries.it outlines the principles involved in qualification of
facility,defining areas & systems to be validated & provides written programme for
achieving & maintaining qualified fecility with validity processes
Validation : it was defined as collection
& evaluation of data from the
process design stage through commercial
productionwhich establishes scientific
evidence that the process is capable of producing quality product
consistently
5) what is process validation
Establishing documented evidence with high
degree of assurance that specific
process will consistently produce a product meeting its predetermined specifications
& quality characteristics
6) what do u mean by MKT ?
MKT is an expression of cumulative thermal stress experienced by a product
at varying temparatures during storage
& distribution
7) temp
& humidity required for tablet compression?
Temp :- NMT 300C
Humidity :- 45 +/- 50 c
8)
what is humidity & relative humidity ?
Humidity- it was amount of water vapour in air
Relative humidity - the amount
of water vapour present in air expressed
as % of amount needed for satuaration at the same temp
9)
what is vaccum & vapour pressure ?
Vaccum
pressure– it was a pressure below normal
atmospheric pressure which wil be used to remove air from surrounding
Ex:
vaccum pumps
Vapor
pressure - it was pressure exerted by a vapor in
thermodynamic equilibrium with its condensed phases(solid/liq) at a given temp
in closed system
10)
what are stability zones & climatic conditions
Zone-1:
great Britain/north Europe/Canada/Russia ( temp-210c RH –
45%) (moderate region)
Zone-2
: USA/Japan/South Europe( temp-250c RH-60%) (subtropical
region)
Zone-3 :
Iran/Iraq/Sudan ( temp- 300c RH- 55%) ( hot region)
Zone-4 : Brazil/Ghana/Indonesia
/Nicaragua/Phillippines (temp-300c RH -70%) ( tropical region )
11)
what do u mean by bracketing & matrixing in stability studies
Bracketing : it was design of
stability schedule such that at any time
point only the samples on extremes e.g
of container size/dosage strength are
studied
Matrixing : it was statistical design of stability
schedule only a fraction of total number of samples are tested at any sampling
point.at a subsequent samping point
,different sets of samples of total numb
would be tested
12) what is limit of cleaning validation
1 It should be
visually clean & no residue should be visible after cleaning
2 No more than 10 ppm of
product will be appear in another
product
3 No more than 0.1% of normal therapeutic dose
of one product wil appear in max daily dose of subsequent product
13)
what is lod & water content
LOD : it is loss of weight expressed as w/w resulting from water
& volatile matter of any kind that can be driven off under specified conditions
WATER CONTENT : it is the amount of water to be present in a sample of drug
compounds
14)
what is the difference between LOD & Water content
Lod : it was
determined by heating the sample below
its melting point in an oven & it
includes all volatile matter including
water content & solvents
Wate content : it was determined by KF titration & it
consit only water content
15) what is difference b/w
calibration& validation& qualification?
Calibration- the set of operations
that establish under specified
conditions the relationship b/w
values indicated by an instrument or
system for measuring and corresponding
values of ref.standerd
Validation – action of proving &
documenting that any process actually & consistently leads to expected results
Qualification- action of proving &
documenting that any premises ,systems & equipments are correctly installed
& lead to expected results
16) DEFINE CAPA
Corrective and
preventive actions
17) In Kf Titration Why We
Hav To Use Di Sodium Tartarate
Both water & di
sodium tartrate are generally used
for standerdisation of kf reagent as we
going to check capacity of 1ml of kf reagent to neutralize water. Hence water
content in standerdisation is very imp
one .as di sodium tartrate contains 15.66% of hydrate it was recommended for
standerdisation instead of water
18) what is formula of kf
standerdisation
Weight of sample x 1000/ titration volume
19) what type of columns
are used in gc
Capillary
& open tubular columns
20) any deviation can be changed into change
control
Yes planned
deviations
21)
why we shouldn’t dispatch reprocess
material to export
Becoz there
may be chances out of specification of product like increase in impurity than
its limit
22)
what is the difference between sonication & homogenization
Sonication is the process of making soluble of undissolved particles by
degassing while homogenization is the process of making uniform solution
23)
what is capacity factor
It is how
much analyte in the sample is
retained with respect to unretained
material
K= RT1-RT0
/RT0
24)
what is the procedure to prepare placebo
Take all raw materials
other than active ingredient & mix it
25) what is stationary
phase
It was
substance inside of a column through which mobile phase flows during separation
process
26) what do u mean by end capping
A column is
said to be endcapped when a small
silyating agent is used to bond residual silanol groups on packing surface
27) how much min
recovery should be in swab sampling
General
limit 85-115% but in swab sampling it should be 85%
28)
what are closely monitor parameters in stability study
Temp &
humidity
29) what is photo stability
It was study
performed to evaluate & demonstrate
that light exposure doesn’t result in unacceptable change in new drug
substances
30)
why 3x sampling plan impimented in process validation
to get the
idea on process capability that whether
the intended process gives the consistent results or not
31) what
is the wave length of polarimeter lamp
589.3 nm
32) in
stability testing if significant change
occurs what wil be the action plan
During
stability testing the term “ significant change “ is used only in case of drug products .when it occurs then do the out
of trend analysis
33)
what should be the min level of working standerd
All values
may complied to predefined specifications .its no need that its assay close to 100%
34)
how we fix validity period of volumetric solution & re-standerdization due
date
Protocol shall be prepared for to establish the restanderisation date for
volumetric solution.date shall be fixed
on the basis of
standerdisation study of volumetric solution on fixed or predefined in protocol interval e.g: 1/2/3/7/15 days etc. the %
rsd shall be NMT 0.2% at all intervals
35)
what is dt for dispersible tablets
3mins
36)
what should be the sampling point in dissolution testing
There is no
specific recommendation for sampling in dissolution test. It is
recommended that a specimen should be withdraw from a
zone midway between surface of dissolution medium &top of rotating
basket /blade NLT 1cm from vessel wall
Where multiple sampling times are specified ,replace the aliquots withdrawn for analysis with equal
volumes of dissolution medium at 370 c
or where it can be shown that replacement of medium is not necessary ,correct for the
volume change in caliculation
Specimens are to be withdrawn only at stated
times within tolerance of +/-2%
37)
what is dt for enteric coated tablets?
2 hrs in
gastero intestinal simulated fluid & 1 hr in phosphate buffer
38)
what is dt for coated tablets ?
30-45 mins
39)
what is the difference between method validation & verification
Method
validation : it is validation of method we
adopt
Method
verification : its high degree of assurance to
verify
40)
what is the difference between drug purity & potency
Purity: it is the absence of unwanted substances like
impurities & contaminents
Potency : it is a measure of drug activity measured in terms of amount of
drug required to produce an effect .
41) why pooled sample is
required in dissolution test
It is the
primary requirement ,the sample
should completely expose to dissolution media at all surfaces .pooled
sample is in completely exposure to dissolution fluid that’s why we use basket apparatus for floating tablets.
42 ) which will give more
drug release paddle or basket
dissolution
Paddle
as we know greater the surface area
greater wil be volume of water
better for dissolution
43) which gases are used
in gc
Helium &
nitrogen
44) what is the difference
between polarimeter lamp & ir lamps
Polarimeter lamp emits the polarized light which in range of visibility (400-700nm) while ir lamp emits
radiation in ir range (I -1000 micro meters)
45) what is the difference b/w temp change
control & deviation
Temp change control : its planned change after
assessing the impact on other functions
Deviation
: unplanned change
46) what is the difference
b/w uniformity of content & content of uniformity
Both terms are same & they are analysed by
individual assay
47)
what is limit of friability of tablets
Friability is
used to determine physical strength of
tablet during packing & transporting with help of friabilator. For this
test accurately weigh 10 tabs & place them in rotating drum of friabilator
at 25 rpm & it was rotated for 100 times
& then remove the tabs & weigh the tabs now.the sample fails
test if anyone of them cracked /cleaved/broken.if the wt loss is >1 % then
test wil be repeated so 1% weight variation wil be acceptable in friability of
tabs
48) what
is the relative response factor in related substances
it is
resonance of peak with respect to main
peak response
49) how
do we choose hplc /gc for sample analysis
Depending
upon compound nature ,degradation,polarity,solubility,molecular weight,volatile
nature,thermal degradation etc
50)
what is recovery factor
It is used
for cleaning validation by following formula
% recovery = area of individual
swab level x std dilution/area of corresponding std solution x sample
dilution x 100
51)
define pka
Its an
equilibrium constant used for
dissociation of weak acid, & also
known as acid ionization constant
