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level: Manuf green Part 1

Questions and Answers List

level questions: Manuf green Part 1

QuestionAnswer
A manufacturer who produces the products of a company without manufacturing facilities is a/ an:toll manufacturer
Primary package system as differentiated from secondary package systems:have a direct effect on product shelf life &are in direct contact with the product
The only true tamper resistant packaging:aerosol containers
Purified water that is free from pyrogenwater for injection
Viscosity enhancers are added to liquid preparations to:improve pourability of products from container & improve palatability
The most inert grade of stainless steel used for high grade productsSS 316
Filtration system which is recommended for handling large quantities ispressure
Filling method which is advisable for highly viscous productsgravimetric filling
The advantages of emulsion over other dosage forms include:increased therapeutic effects ,ability to mask unpleasant odors, increased spreading ability
Aggregates of powders which adhere or bond to each other to form larger particlesgranules
Storage conditions for capsules21-25ºC,35-50% RH
Substance that “glue” powder together causing them to form granulesbinder
An agent that acts between surfaces in relative motion to prevent friction and wearlubricant
In film coating, when additives migrate to the surface, the problem is called:sweating
An anteroom which separates the sterile from non sterile is a/an:airlock
Area with no more than 100 particles of 0.5 micron size per cubic foot of environment:Class 100
A very simple, sensitive and fast test for pyrogens using the amoebocyte of the horse shoe crab.LAL Test
Ampules are sealed by:Pull sealing &. Tip sealinge
The period in which the product remain acceptable for use:Shelf life
Flow property of liquid is related to:Viscosity
Dispensing equipment in the name of suspension includes:Blenders ,Colloid mill & Impellers
A suspension may be stabilized through the use of:Suspending agents ,Viscosity enhancing agents, Hydrocolloid
Suspensions are evaluated by:"Sedimentation, Measuring of Particle size,& Ease of redispersability
The ff are natural emulsifying agent, except:Tween 80
Water soluble abases are prepared fromPEG
Polyols may be used as:humectant in creams
Preservatives are added to semisolid preparations to be prevent the ff exceptcontainer
Mixing equipment for acid materialsSigma blade mixer
An ideal drug delivery system (DDS) iscapable of controlled delivery rates,not highly sensitive to physiological variables,c. based on physicochemical principles
Filtration process wherein the liquid passes through one filter pad or diskparallel
A gravity operated filling set up is used for liquids which arefree flowing
Suspension adjunct used to prevent the product from drying at topical applicationhumectant
The aggregation of the dispersed globules into loose clusters within the emulsionflocculation
CGMP meansCurrent Good Manufacturing Practice
Group which is responsible for auditing the control system for evaluating product qualityQuality assurance
The disintegration medium of plain uncoated tablet isDistilled water
Quality control test that are performed on granules before compression into tablets are except:angle of repose
The most common method of tableting active ingredients which are chemically incompatibleuse double layer tableting
Sealing of ampule is done byPull sealing &. Tip sealinge
Bullet shaped capsules are calledpulbules
This is used to increase the resistance of gasSulfur dioxide
The animal of choice for in vitro rectal absorption studiesdog
Method that will produce tablets of best qualitywet granulation
Bubble test measure the efficiency of:membrane filter
A processing problem encountered only in the manufacture of tablets:double impression
The coalescence of oil globules in a o/w emulsion is called:cracking
The ff. are true for Spans, except:they have high HLB values
A variation of dry gum method of preparing emulsions using volatile oil is added to acacia in a bottle:Bottle method
Antioxidants which block an oxidative chain reaction in which they are not usually consumed:BHT
These are gas sterilants, except:carbon dioxide
A sterilization method which destroys microorganism b y cellular protein coagulation:autoclaving
The usual contaminants of ophthalmic preparations are the ff., except:Staphylococcus aureus
A commonly used capsule diluent:lactose
An opacifying agent for capsules:titanium oxide
A common levigating agent:mineral oil:
Method used for the incorporation of small amounts of potent drugs with a large amount of diluent::geometric dilution
The ff. excipients impart satisfactory compression characteristics to the tablet formulation except:disintegrant
Tablet weight is determined by:volumetric fill of the disc
One part of a slightly soluble material will dissolve in ________ part of solvent100-1000
Brandy and whiskey are classified as:spirits
The reduction of camphor with the aid of alcohol is called:pulverization by intervention
The prominently printed element on the label:generic name
Invert sugar has the tendency to darken in color due to:levulose
A near saturated solution of sucrose in water:simple syrup
simple syrup35
Thixotropy is a characteristic demonstrated by:gels
Galenicals are also called:extractives
The injection of large of volumes of a solution into substances tissue to provide a continuous, abundant drug supply is called:hypodermicyclics
Excessive use of binders in tablet affectd:all
Impart cohesive qualities to the tablet granulation:binder
Buccal tablets are intended to be dissolved:swallow
These are necessary components of a stable emulsion, except:electrolyte
Problem often encountered in suspensions:caking
The different methods of determining the emulsion type are the ff., except:Dry Gum
The container of choice for parenteral:glass
The container of choice for ointments:collapsible tubes
Which of the ff. is not classified as a lubricant?lactose
Spans & Tweens are:surfactants
Filtration of a solution to a high degree of clarity:polishing
These are advantages of tablets, except:prolonged dissolution
HEPA filters are used for filtration of:air
For compacting the materials in the tablet machine:punches
Tablet granulations can be dried faster using:fluid bed dryer
The partial or complete separation of the top or bottom of a tablet from the main body:capping
Used for mixing powder mixtures in large volume quantity:V-blender
A roller mill is used to reduce the particle size of powders in:ointment
This is not part of the master formula record:price per dosage unit
This part of the sugar coating process is to round off tablet contours rapidly:subcoating
DisintegrantStarch
FillerLactose
Active IngredientPrimaquine PO 4
BinderPVP
LubricantStearic acid
Which of the ff additives in parenterals reduces the f\pain of injection in areas with nerve endings?tonicity adjusters
Weight variation test is carried out iin:20 tabs
The water resistance of glass containers is tested byamount of alkali released into water
Primary packaging components exceptlabels
The degree of freedom is used in calculation ofstandard deviation
To control microorganisms in the air is toinstall UV lamps in several areas
The work “quality” SQC refers to characteristic of a product from:quantitative &qualitative
The measure of the variation of individual observations around the average is:standard deviation
Advantages of plastic containers over glass, except:permeability
In labeling of a product, an unlabeled portion is provided forviewing the contents
The material present in both enteric and film coatingcellulose acetate phthalate
lyophobic substance is easily wet bynonpolar solvents
Characteristics of iirigation solutions to wash wounds and body cavitites may besterile &pyrogen free
Plastic material used for ophthalmic solutions as package and applicator ispolyethylene
A colloid mill is used for the ff, except:granulation
Use of buffers in parenteralspH stabilizer &tonicity contributor
Foam in emulsion is preventedapply compressed air &add antifoaming agent
the dispensing division of the warehouse requireslicensed pharmacist
Room temperature recognized by USP istemp at the working area
Uneven distribution of colors on the surface of tablets ismottling
The Board of Trustees of a company functions as theprotector of the company’s asset &prepare policies
The inspection and checking section of QC is responsible forsampling of raw materials
The part of the transdermal drug delivery system patch where the drug is storedreservoir
Practical method of determining method of hardness isRule of Thumb
Method of tablet manufacture for easily compressible or adhesive ing isdirect compression
Limulus amoebocyte lysate is obtained fromking crab
Stoke’s Monsanto tester is used to measurehardness
Hemodialysis is employed to remove toxins from theblood
Implantation pellets are those which containactive ing
In the manufacture of semisolid emulsions, the mixing of the oil and aqueous phases is done at the temperature of:70-72ºC
Hard gelatin capsules are also referred to as:dry-filled capsules
To identify pharm. Products that are registered in BFAD, the label consists of:DR number
Quarantined materials delivered in the warehouse are:subject to test and assay
Advantage of liquid medicines:rapidly absorbed in the body
Instability of drug substances in liquid form may be caused by:variation in pH&light of radiation
Disadvantage of glass material used in packaging of liquids is:releases insoluble flakes upon storage
To increase viscosity of the aqueous phase of an emulsion is to:add dissolved macromolecules
In suspension formulation, the suspension adjuvants may bebuffers
Suspending agents added to suspension formulations, except:parabens
In semisolid preparations, petrolatum is a common hydrocarbon base due to its:consistency
Large volume parenterals are employed for:maintenance therapy &replacement therapy