MANUF pacop.pdf

PACOP BLUE The ability of a particular formulation in a specific container to remain within its physical, chemical, therapeutic and toxicological specification is called a. Overage b. Shelf-life c. Validation d. Stability The color for quarantine sticker is a. Green b. Yellow c. White d. Red An ex...

PACOP BLUE The ability of a particular formulation in a specific container to remain within its physical, chemical, therapeutic and toxicological specification is called a. Overage b. Shelf-life c. Validation d. Stability The color for quarantine sticker is a. Green b. Yellow c. White d. Red An example of primary packaging material is a a. Insert b. Brochure c. Label d. Seal The following are important document in the manufacture of drugs and cosmetics, EXCEPT: a. Manufacturing monographs b. Batch records c. CGMP guidelines d. Standard operating procedures Retention period for finished products should be a. At least 2 years after the distribution of the first lot b. One year after the expiration date of the product c. At least 3 years after the manufacture is completed d. At least 1 year after the expiration date of the last lot PACOP PINKAVOLITY 11. Overages in the manufacture of pharmaceuticals are 1. A class of raw materials, which are to be subjected to justified on the ff. conditions; tests and assays by the Quality Control department, and A. Clinical studies show that the average is are not yet to be use in the production of therapeutically safe pharmaceuticals; B. The labile/unstable active cannot be possibly A. Approved for use materials standardized B. Rejected materials C. The overage allows for the equilibrium of the active C. Quarantined materials within acceptable limits D. All of the above 2. A standard document, which give instructions to the Production Department to produce a pharmaceutical 12. It refers to the addition of an active in an unstable product for distribution/sale in the market; pharmaceutical preparation, to compensate for the loss A. Batch Production Record during manufacture; B. Finishing Order A. Chemical modification of the drug C. Master Formula B. Manufacturing Overages D. Manufacturing Order C. Manufacturing allowances D. All of the above 3. A section of the warehouse which houses products which have been bottled, stripped or blister-packed, but 22. A type of stability test, which involves temperatures not yet labelled or packed into boxes/cartons. And are in 10-degree increments. This test is performed to still awaiting the final disposition of the Quality Control identify the products of degradation of a product; Department; A. Real time stability test C. Stress test A. Finished Goods Section B. Accelerated stability test D. All of the above B. In-Process Section C. Returned Goods Section 24. The cause of capping, chipping and lamination of D. Raw Materials Section compressed tablets; A. Wear and tear punches and die cavities Note: B sagot ni ma’am B. Difficulty in cleaning monograms which enclosed areas 4. The Planning and Scheduling Division coordinates C. Poor flow rate of granulations with this department on what products are required for D. Unequal lengths of the lower punches supply and market distribution, then plans and schedules the manufacture of the product; 61. CGMP means; A. Marketing C. Inventory Control A. Current Good Manufacturing Practice B. Purchasing D. Production Control B. Current General Manufacturing Program C. Current General Manufacturing Practice 5. A method of filling liquids wherein the product is D. Current Good Manufacturing pumped, at constant pressure, through an orifice of constant diameter and size. The fill amount is measured 71. An equipment associated with the maintenance of by the stroke of the piston; dust-free; A. Volumetric A. Laminar Flow Hood C. Ultra Violet Lamp B. Gravimetric B. Autoclave D. Magnetic Resonance C. Constant level 94. This statement is tru of the FIFO Policy; 7. A special technique for poorly-soluble drugs, in which A. Contains information regarding the activity of the it is improved by the addition of a water-miscible component solvent, in which the drug will have increased water B. Prevents contamination and mix-ups solubility; C. Assure that the oldest stock of material is used A. Solubilization C. Complexation first B. Chemical modification D. Co-solvency D. All of the above 8. A class of preservative, which are often used for 95. Which of these is the adverse effect of a product ophthalmic, nasal and parenteral products, but in oral recall? liquid preparations; A. A function of biological testing in a laboratory A. Mercurials B. Should be filed by a dissatisfied customer B. Quaternary ammonium compounds C. Inflicts damage on the reputation and good standing C. Aldehydes of the company D. All of the above Note: C sagot ni chatgpt tas A sa coursehero so idk 9. A filter media composed of nylon, Teflon, PVC and silver. It is employed fo the micro-filtration of 96. Which of the ff. Is the function of Research and parenteral solution; Product Development Department? A. Membrane Filter Media C. Filter cloth, non-woven A. Pilot Batch production B. Filter cloth, woven D. All of the above B. In-process quality testing C. Manufacture and packaging 10. The following are the effects of Product Recalls to a D. Clinical testing drug-manufacturing firm; A. Financial Loses C. Harmful and Bad Publicity 98. Water soluble bases for medicated application are B. Mix-ups and Errors D. All of the above prepared from; A. Polyethylene glycol C. Petroleum jelly 274. Quarantined materials delivered in the warehouse B. Sorbitol D. Mineral oil are: A. Subject to test and assays 113. A system for ensuring that products are consistently B. Releasable to production department produced and controlled according to quality standards. C. Rejectable It is designed to minimize the risks of errors involved in D. In-process products any pharmaceutical production, which cannot be E. For approval by the BFAD eliminated through the final testing of the products; A. First in-First out Policy 19. Raw materials which are widely used as humectants B. Quality Control in semi-solids to prevent “crusting” in ointment and C. Current Good Manufacturing Practice creams contained in jars; D. Safety First Policy A. Glycerin C. Sorbitol, 70% B. Propylene Glycol (low MW) D. All of the above 138. A filter aid which is used for straining syrupy liquids, and is unaffected by molds and fungus; 248. The most useful preservative that is effective A. Bonded fabrics C. Nylon against bacteria and molds is: B. Talc D. Activated charcoal A. Parabens B. Sodium benzoate 139. It refers to the binding of drug molecules to the C. Glycerine polymer material of the plastic container; D. Alcohol A. Sorption C. Adsorption E. Propanol B. Absorption D. Leaching 137.A filter aid which forms a fine surface 141. It refers to any distinctive combination of letters deposit to screen out all solid, preventing and/or numbers or both, by which the complete history of the clogging of the supporting filter media; the manufacture, control, packaging and distribution of a A. Infusorial earth C. Membrane filter batch or lot of drug is determined; B. Kraft paper D. Nylon A. Drug Registration Number B. Lot number C. Manufacturing Order Number D. Finishing Order Number 144. A section of the plant department consist of products which have been stripped, bottled or packed, but not yet labelled nor packed into boxes and cartons. As it waits the results of quality control test and assays; A. Finished Good Section B. In-Process Section C. Raw Materials Section D. Returned Goods Section 146. A method of filling viscous liquid preparations in a very large containers; A. Volumetric C. Gravimetric B. Constant Level D. All of the above 258. Control records required in the manufacture of drugs: A. Distribution records B. Sales records C. Master formula D. Assay procedures E. BFAD records 268. Plastic material used ophthalmic solutions as package and applicator is: A. Polypropylene B. Polyethylene C. Polystyrene D. PVC E. Any fine plastic material 273. Caps used to hold rubber closure in place for vials are made of: A. Tin B. Aluminium C. Copper D. Tin coated metal E. Plastic coated tin PACOP GREEN 14. The water resistance of glass containers is tested by 1. A means of administering drugs as formulated a. amount of alkali released into water preparations is called: b. amount of acid released into water a. pharmaceutical c. dosage forms c. changes in pH b. drug delivery system d. any of the above d. none 2. A manufacturer who produces the products of a 15. Primary packaging components except company without manufacturing facilities is a/ an: a. labels d. caps a. ethical manufacturer c. biological manufacturer b. bottles e. stoppers b. proprietary manufacturer d. toll manufacturer c. tubes 3. Primary package system as differentiated from 16. The work “quality” SQC refers to characteristic of a secondary package systems: product from: a. are in direct contact with the product a. quantitative c. identification b. have a direct effect on product shelf life b. qualitative d. a & b c. AOTA d. None 17. Advantages of plastic containers over glass, except: a. lightness in weight c. lower transportation 4. The only true tamper resistant packaging: b. permeability d. resistance to impact a. aerosol containers c. breakable caps b. sealed tubes d. shrink seals 18. A lyophobic substance is easily wet by a. polar solvents c. water 5. The period in which the product remain acceptable for b. nonpolar solvents d. hydro alcohols use: a. Stability c. Accelerated Stability Studies 19. Plastic material used for ophthalmic solutions as b. Shelf life d. any of the above package and applicator is a. polypropylene c.polystyrene 6. CGMP means b. polyethylene d. PVC a. Current Good Manufacturing Practice b. Current General Manufacturing Program 20. the dispensing division of the warehouse requires c. Current General Manufacturing Practice a. licensed pharmacist c. experienced scientist b. licensed chemist d. a & b 7. The quality of a medicinal and a related product is the sum of all factors which will contribute directly or 21. Room temperature recognized by USP is indirectly to the products a. 25oC c. 20oC a. safety c. acceptability b. 10-30oC d. temp at the working area b. effectiveness d. AOTA 22. The Board of Trustees of a company functions as the 8. Group which is responsible for auditing the control a. protector of the company’s asset system for evaluating product quality b. prepare policies a. Quality Control c. Production c. active planning b. Quality assurance d. Medical d. a&b 9. The prominently printed element on the label: 23. The inspection and checking section of QC is a. brand name c. pharmacologic category responsible for b. Rx symbol d. generic name a. sampling of raw materials c. chemical assaying b. testing sterility of products d. doing pyrogen test 10. The container of choice for parenteral: a. plastic c. metals 24. To identify pharm. Products that are registered in b. glass d tubes BFAD, the label consists of: a. expiry date c. DR number 11. The container of choice for ointments: b. Bar marks d. category a. jars c. collapsible tubes b. cans d. widemouth bottle 25. Packaging and labeling operations are controlled to: a. prevent mix ups b/w drugs and labels 12. Plastic containers are not recommended for b. assure that only those products that meet the pharmaceuticals because: standards are distributed a. vapors permeate through the walls of the container c. identify the finished products with a control number b. leaching of constituents from the plastic to the product d. AOTA c. absorption of the drug molecules to the surface of the plastic 26. Quarantined materials delivered in the warehouse d. all of the above are: e. none of the above a. subject to test and assay c. rejectable b. releasable to production dept. d. in-process products 13. This is not part of the master formula record: a. complete batch formula 27. Advantage of liquid medicines: b. price per dosage unit a. special techniques required for poorly soluble drugs c. weight of each b. rapidly absorbed in the body d. description of container & closure c. easy to manufacture d. requires pharmaceutical elegance 28. Instability of drug substances in liquid form may be 39. The barcodes imprinted on labels of products serve caused by: to: a. variation in pH c. light of radiation a. distinguish one product from another b. reduced temperature d. a&c b. impart elegance c. meet BFAD requirement 29. Disadvantage of glass material used in packaging of d. comply with DOH requirement liquids is: a. releases insoluble flakes upon storage 40. These are quality assurance functions, except: b. resistance to decomposition a. product forecasting c. oxide contents may be reduced b. auditing, and control of all manufacturing documents d. b & c before and after production c. CGMP monitoring 30. CGMP standards and regulations are enforced by d. environmental control BFAD for the purpose of: a. assuring quality 41. One of the ff. situations can avoid cross b. assuring the protection from moisture contamination and mix-ups: c. developing new product a. components are tightly sealed d. assuring sales b. improper partitioning of working areas c. components are improperly dispersed 31. The president of a company has the function of: d. wrong label a. protecting the assets of the company b. active planning and control of business 42. The manufacturing batch record should contain the c. management of the major department ff. information, except: d. a and c a. in-process test, finished product QC test results b. general manager’s signature 32. Complaint about a product may be: c. manufacturing procedures a. adulteration c. high price d. dispensing batch number quantitative and qualitative b. decomposition d. a & b formula 33. The production department of a pharmaceutical 43. The QA inspectors usually inspect and audit manufacturing establishment is in charge of, except: warehouse CGMP’s : a. production personnel control a. stock rotation (FIFO) b. labeling & other packaging materials b. all of these answers c. inventory control c. separation of materials, quarantine, approved, d. in-process analysis rejected d. protection of material from cross contamination 34. One of the ff. is not a QC function: a. inspection of container 44. Reaction kinetics study can help predict the: b. labeling & other packaging material a. shelf life c. toxicity c. inventory control b. effectivity of a formulation d. potency d. in process analysis 45. In the CGMP, we usually consider the: 35. Documentation is the main responsibility of: a. building c. equipment a. central release office b. personnel d. all b. checking & investigation section c. purchasing department 46. Soda Lime glass is also known as: d. sales, promotion and merchandising department a. Type I c Type III b. NP d. b &c 36. It means any establishment engaged in operations involved in the production of drugs including 47. Container impervious to air: propagation, processing, compounding, finishing, filling, a. tight container c. closed container packing, repacking, and labeling in view of b. hermetic container d. single dose container storage distribution or sale of the product: a. drug distributor c. drug manufacturer 48. If you are QC inspector, what critical defect if found b. drug trader d. none of the above should stop the packaging operation and could be processed if results of investigation are satisfactory: 37. Statement of expiration date assure of: a. inverted label c. smeared label a. absence of interaction c. full therapeutic efficacy b. wrong label d. misaligned label b. absence of toxicity d. recovers from ailment 49. Highly resistant borosilicate glass is also known as: 38. The expiration date of the paracetamol tablet states a. Type I c. Type III “January 1999”. This statement means that, by January b. Type II d. NP 1999, the product will have lost its activity: a. less than 90% 50. Type of container that protects the content from b. sufficient activity to be outside the USP extraneous solids, liquids, or vapors from loss of the monograph requirement drug: c. meet BFAD requirement a. hermetic c. tight d. comply with DOH requirement b. well-closed d. light resistant 51. The product inserts for many drug products contain statements. Which of the ff. sequences lists the 3 type of caution in the order of least to most serious? a. contraindication, precaution, warning b. precaution, warning, contraindication c. warning, contraindication, precaution d. contraindication, warning, precaution 52. Release or movement of the components of the container into the contents: a. sorption c. leaching b. breathing d. porosity 53. Function of a package include: a. for convenience c. for protection of content b. for legal compliance d. all of the answers 54. Accdg. to USP standard, freezer or refrigerator can be used to store pharmaceuticals that specify storage in a : a. cool place c. dark place b. cold place d controlled room temperature 55. To assign in assuring the stability of a dosage form during transport and storage, the label shall indicate: a. storage condition c. concentration of the drug b. expiry date d. any of the above 56. The temperature of a cool place is: a. not more than 8oC c. 15-30oC b. 8-15oC d. 25oC 57. The usual storage condition specified for biologicals is: a. room temperature c. 2-8oC b. below 2oC d. a cool place 58. 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 a. FIFO c. cost cutting b. preformulation purchasing d. just-in-time 59. The DDB is under the jurisdiction of the BFAD. a. True b. False 60. The production control department of the plant division is in charge of inventory. a. True b. False PACOP RED Inexact & inadequate procedure is one cause of variation for: Who weighs & measure the ingredients & transfer them A. Materials to the respective mfg. area. B. Machines A. In process Section C. Methods B. Dispensing pharmacist D. Man C. Inventory control E. All of the above D. Production control E. All of the above Variation between batches from the same supplies is for: A. Materials Dishonesty & fatigue is one cause of variation of: B. Machines A. Materials C. Methods B. Machines D. Man C. Methods E. All of the above D. Man E. All of the above Improper working conditions is one cause of variation of: A. Materials Variation between supplies of the same substance for: B. Machines A. Materials C. Methods B. Machines D. Man C. Methods E. All of the above D. Man E. All of the above Aging & improper care is one cause of variation of: A. Materials B. Machines C. Methods D. Man E. All of the above Negligence by chance is one variation of: A. Materials B. Machines C. Methods D. Man E. All of the above Difference in adjustment of equipment is one variation of: A. Materials B. Machines C. Methods D. Man E. All of the above Variation w/n a batch is for: A. Materials B. Machines C. Methods D. Man E. All of the above Variation of equipment for the same process if for: A. Materials B. Machines C. Methods D. Man E. All of the above Inadequate training & understanding is one cause of variation for: A. Materials B. Machines C. Methods D. Man E. All of the above