| 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 production | just-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 container | liner |
| 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 polyester | coil |
| 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 are | viscous |
| A typical erythema score of 2 in the irritation test for ointment means | intense erythema |
| Anhydrous lanolin has the ff property | more stable and free from rancidity |
| Penetrometers are used to measure consistency and viscosity of | ointments |
| Mixing equipment for solid materials except | Fitz 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 easier | are more stable |
| A parvule is | granule |
| Materials added to provide cohesion in components for compression | binder |
| 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 are | additives |
| 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 granules | dry granulation method |
| Aside from fluidity, powders for compression must possess | compressibility |
| Drugs that are available as sustained release dosage forms utilizing ion exchange resins include: | ionamine |
| Film coating problem due to internal stress | cracking |
| 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, except | Cab-O-sil |
| Content uniformity is used to ensure which of the ff qualities in tablet products | potency |
| For rapid disintegration of compressed tablet, this range of concentration of starch is recommended: | 10-15% |
| Rule of thumb is used for testing | compressed 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 tablets | gelatin solution |
| Separation of a tablet into 2 or more distinct layers | lamination |
| Part of a tablet machine which controls the size and shape of the tablet is | die |
| 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 mills | granulate |
| One of the ff substances is not used as lubricant in tablet manufacture | starch |
| One of the ff is not an advantage of multi layered tablets | accurate 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 |
