1)What do u mean by MACO & NOEL MACO-max allowable carry over NOEL – no observed effect leve; Both of themare 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 It should be visually clean & no residue should be visible after cleaning No more than 10 ppm of product will be appear in another product 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