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level: Manuf green part2

Questions and Answers List

level questions: Manuf green part2

QuestionAnswer
Insoluble powders for ophthalmic preparations must be:impalpable to the touch
Dialysis solutions as life-saving preparations has the ff characteristics, except:used to separate RBC from WBC
CGMP standards and regulations are enforced by BFAD for the purpose of:assuring quality
The president of a company has the function of:active planning and control of business
Plastic containers are of advantage to manufacturers for us ein:ophthalmic solutions &packaging of IV infusion
Polyols may be added to cream formulation as:humectant
Aspilet tablets for children are:chewable
An aerosol is a dispersion of:solid in gas
type of ointment base known as creams is:water removable base
Pfizer tester that determines force to break a tablet is used to measure:hardness
Transdermal delivery system is a sophisticated patch that delivers the drug from the skin:bloodstream
Implantation tablets are those which are administered:insertion into body tissues
Accdg. to Stoke’s law, the sedimentation rate of suspension is directly proportional to:particle size
Improperly sealed ampules should be tested for:leak
Single containers may be in ampules, vials, or in large 250mL- 1000mL.TRUE
Tamper-proof seals are popular nowadays to allow easy pilferage of the contents.FALSE
Biologic products are stored at room temperature.FALSE
Buccal tablets are those which contain drugs to be absorbed thru the oral mucosa.TRUE
The 2 acids contained in effervescent tablets are citric acid and acetic acid.FALSE
LAL Test for pyrogens is interpreted by rise in temperature of rabbits.FALSE
In ampule sealing, a tip sealing is characterized by a bead at the tip of the ampule.TRUE
One great advantage of pharmaceutical aerosols is that medication is dispensed in a ready-to-use form at the push of a button.TRUE
For semisolid aerosol, the formulation is similar to other semisolid preparation but depends on nitrogen gas to the contents from package.TRUE
Homogenization of an emulsion is done to uniformly disperse the insoluble solid drug in the vehicle.FALSE
In the manufacture of emulsified semisolid, the mixing of the phases is done at a temperature of 43-45ºC for intimate blending.FALSE
Hydrocarbon waxes are added to semisolid formulations to increase the viscosity of mineral oil and prevents separation.TRUE
The natural emulsifiers like acacia form a colloidal layer to prevent coalescence of droplets.FALSE
Creaming in emulsions is the separation of emulsified droplets which are denser that settle at the container.FALSE
The DDB is under the jurisdiction of the BFAD.FALSE
Spray drying technique can produce finely divided particles for suspension formulation.TRUE
Flint glass refers to the amber colored glasses used to protect from light.FALSE
The production control department of the plant division is in charge of inventory.TRUE
The approved for use materials are labeled with red color.FALSE
The medical department of a manufacturing establishment is in charge of:house organ publication
The production department of a pharmaceutical manufacturing establishment is in charge of, except:production personnel control
One of the ff. is not a QC function:inventory control
Documentation is the main responsibility of:central release office
It means any establishment engaged in operations involved in the production of drugs including propagation,processing, compounding, finishing, filling, packing, repacking, and labeling in view of storage distribution or sale of the product:drug manufacturer
Statement of expiration date assure of:full therapeutic efficacy
The expiration date of paracetamol tablet states “January 1999”. This statement means that, by January 1999, the product will have lost its activity:b. sufficient activity to be outside the USP monograph requirement
The barcodes imprinted in labels of products serve to:distinguish one product from another
These are quality assurance functions, except:product forecasting
One of the ff. situations can avoid cross contamination and mix-ups:components are tightly sealed
The manufacturing batch record should contain the ff. information, except:general manager’s signature
If a bottle of tablets has an expiration date of January 1999, the pharmacist may,dispense the tablets only until January 31, 1999
Reaction kinetics study can help predict the:shelf life
Any substance of a drug product intended to furnish pharmacologic effect is:drug substance &actives
The concept where raw materials are purchased only at a time when it is needed and at a quantity enough to carry out a single productionjust-in-time
Soda Lime glass is also known as:NP & Type III
Container impervious to air:hermetic container
If you are QC inspector, what critical defect if found should stop the packaging operation and could be processed if results of investigation are satisfactory:wrong label
Highly resistant borosilicate glass is also known as:Type I
It refers to the statement regarding the conditions, wherein the use of the product may cause harm to the patient:contraindication
Type of container that protects the content from extraneous solids, liquids, or vapors from loss of the drug:tight
Single unit container include the ff., except:collapsible tubes
It refers to the instruction and special care required in the use of the product to avoid undesired effects and to ensure the safe and effective use of the drug:precaution
Component of closure that inserted in a cap to effect a hermetic seal between the closure and the containerliner
Common component of cap liners, stoppers and parts of dropper assembles:rubber
One of the ff. is not an advantage of plastic over glass containers:permeability
The all glass container for small volume parenterals:ampule
Tamper-resistant package except:liner
Material of plastic containers that can be remelted and reprocessed, except:melamine formaldehyde
The product inserts fro many drug products contain statements. Which of the ff. sequences lists the 3 type of caution in the order of least to most serious?precaution, warning, contraindication
Advantages of glass containers, except:resistance to impact
Package component used to prevent during shipping including cotton, rayon and polyestercoil
Primary packaging materials, except:labels
Release or movement of the components of the container into the contents:leeching
Multiple dose containers include:vials
Accdg. to USP standard, freezer or refrigerator can be used to store pharmaceuticals that specify storage in a :cold place
Accdg. to the USP monograph instruction, protect from light indicates storage in:light resistant container
To assign in assuring the stability of a dosage form during transport and storage, the label shall indicate:storage condition
The term soluble refers to part s of solvent that can dissolve 1 part of solute is:30-Oct
The temperature of a cool place is:8-15ºC
When 1 part of the solute dissolves in 1-10 parts of solvent, it is:freely soluble
The usual storage condition specified for biologicals is:2-8ºC
Type of mill which makes use of compressed gas to cause turbulence inside the chamber.fluid energy mill
The ff. are preservatives used in dosage forms, except:PG
Filtration process wherein the liquid passes thru one filter pad or disc:parallel
The composition of oral rehydration are:glucose, Na, K, Cl
The generally accepted liquid product artificial sweetener:saccharin
Veegum is a/an:clay
Type of resin that is used to deionize water:synthetic
Buffers are used:to maintain pH pf solution thus attaining maximum stability
A finished product where sterility is not at its maximum observance:otic
Pressure operated filling set up is used for liquid which areviscous
A typical erythema score of 2 in the irritation test for ointment meansintense erythema
Anhydrous lanolin has the ff propertymore stable and free from rancidity
Penetrometers are used to measure consistency and viscosity ofointments
Mixing equipment for solid materials exceptFitz Patrick Chilsonator
Solid dosage forms are more advantageous than liquid forms because of the ff reasons, except:method of manufacture is easier
method of manufacture is easierare more stable
A parvule isgranule
Materials added to provide cohesion in components for compressionbinder
Molded lozenges are referred to as:Pastilles
Content uniformity tests is to be performed for all tablet products whose active ingredient is:50 mg or less
Starch, povidone, Mg Stearate, and lactose added to Aspirin tablets areadditives
For the disintegration test for enteric coated tablets, the immersion fluid is:Simulated Gastric fluid TS
The method for the preparation of compressed tablets wherein the granulation is formed by compacting large masses of the mixture and subsequently crushing and sizing these pieces into smaller granulesdry granulation method
Aside from fluidity, powders for compression must possesscompressibility
Drugs that are available as sustained release dosage forms utilizing ion exchange resins include:ionamine
Film coating problem due to internal stresscracking
The disintegration medium for plain uncoated tablet is:Distilled Water
The most commonly used of determining the particle size of powders and granules is:sieve method
The ff are binders, exceptCab-O-sil
Content uniformity is used to ensure which of the ff qualities in tablet productspotency
For rapid disintegration of compressed tablet, this range of concentration of starch is recommended:10-15%
Rule of thumb is used for testingcompressed tablets
A tablet formulation calls for 2 active ingredients which are chemically incompatible. The best method to be used is:double layered tablets
Poorly manufactured tablets may have small pinholes on the surface, this defect is called:picking
In the preparation of effervescent tablet, the most important ingredients necessary to give the effervescent effects are:NaHCO3 and Citric acid, Na2CO3 and Tartaric acid
Common binder used in tabletsgelatin solution
Separation of a tablet into 2 or more distinct layerslamination
Part of a tablet machine which controls the size and shape of the tablet isdie
The method of tablet manufacture for easily compressible or adhesive ingredient is:direct compression
One of the ff does not apply to uses of colloid millsgranulate
One of the ff substances is not used as lubricant in tablet manufacturestarch
One of the ff is not an advantage of multi layered tabletsaccurate control of the delayed action part
The ability of the tablet to withstand abrasion in packaging, handling and shipping is evaluated by its:friability
This is a common lubricant for tablets:Mg stearate
Which of the ff is/ are used in tablet formulation to reduce friction during tablet compression?Calcium stearate , Mg stearate, Stearic acid