Manuf Flashcards
IT IS ONE OF THE TOOLS OF ORGANIZATION
A. DIVISION OF RESPONSIBILITY
B. CHART
C. OBLIGATION OF DUTY
D. BOTH A & B
B. CHART
IT IS A COMBINATION OF MANPOWER, MONEY AND MACHINES
ORGANIZATION
SECTION IN THE WAREHOUSE DEPARTMENT
A. DISPENSING SECTION
B. FINISHED GOODS AREA
C. QC AREA
D. BOTH A & B
D. BOTH A & B
WHICH IS NOT A SECTION OF WAREHOUSE DEPARTMENT
A. RETURNED GOODS SECTION
B. REJECTED FOR USE
C. APPROVED FOR USE
D. INVENTORY SECTION
D. INVENTORY SECTION
THIS WATCHES CLOSELY AND RECORDS ALL MATERIALS USED IN THE PRODUCTION
INVENTORY
IDENTIFIES AS THE CHAIN OF COMMAND FROM TOP TO BOTTOM OF THE ORGANIZATION.
LINE
CONSIST OF THE PRODUCT WHICH HAVE BEEN BOTTLED, STRIPPED, PACKED BUT NOT GET LABELED:
IN PROCESS SECTION
WHO PREPARES THE MANUF ORDER BASED ON THE MANUFACTURING FORMULA
PRODUCTION CONTROL
ANY DISTINCT COMBINATION OF LETTER OR NUMBER OR BOTH WHICH HISTORY OF THE MANUF, CONTROL, PACKING AND DISTRIBUTION OF A BATCH
A. BATCH
B. LOT NUMBER
C. COMPONENT
D. QUALITY CONTROL
B. LOT NUMBER
IN CHARGE OF THE PREPARATION OF THE MANUFACTURING FORMULA OF THE COPY WAS RENTED WITHOUT THE ACTUAL AMOUNT TO BE MANUFACTURED?
QUALITY CONTROL HEAD
A SPECIFIC HOMOGENOUS QUALITY OF A DRUG
PRODUCED ACCORDING TO A SINGLE NO
A. BATCH
B. LOT NUMBER
C. COMPONENT
D. QUALITY CONTROL
A. BATCH
RESPONSIBILITY OF AN ORGANIZATION TO DETERMINE THE SYSTEMS, FACILITIES AND WRITTEN PROCEDURES ARE IN PLACED
A. TECHNOLOGICAL
B. AESTHETIC
C. QUALITY CONTROL
D. QUALITY ASSURANCE
D. QUALITY ASSURANCE
A MANUFACTURER WHO PRODUCES THE PRODUCTS OF A COMPANY WITHOUT MANUFACTURING FACILITIES
A. ETHICAL MANUFACTURER
B. PROPRIETARY MANUFACTURER
C. BIOLOGICAL MANUFACTURER
D. TOLL MANUFACTURER
D. TOLL MANUFACTURER
INGREDIENTS ARE WEIGHED AND MEASURED AND TRANSFERRED TO THE RESPECTIVE MANUFACTURING AREA
A. IN-PROCESS SECTION
B. DISPENSING SECTION
C. INVENTORY CONTROL
D. PRODUCTION CONTROL
B. DISPENSING SECTION
GROUP WHICH IS RESPONSIBLE FOR AUDITING THE CONTROL SYSTEM FOR EVALUATING PRODUCT QUALITY
A. QUALITY CONTROL
B. QUALITY ASSURANCE
C. PRODUCTION
D. MEDICAL
A. QUALITY CONTROL
CGMP MEANS
A. CURRENT GENERAL MANUFACTURING SYSTEM
B. CURRENT GOOD MANUFACTURING PRACTICE
C. CURRENT GOOD MANUFACTURING PROGRAM
D. CURRENT GENERAL MANUFACTURING PROGRAM
B. CURRENT GOOD MANUFACTURING PRACTICE
DOCUMENTATION IS THE MAIN RESPONSIBILITY OF
A. PURCHASING DEPARTMENT
B. CHECKING & INVESTIGATION SECTION
C. CENTRAL RELEASE OFFICE
D. SALES PROMOTION
C. CENTRAL RELEASE OFFICE
THE APPROVED FOR USE MATERIALS ARE LABELED:
A. RED
B. YELLOW
C. GREEN
D. BLUE
C. GREEN
THE BAR CODES PRINTED IN LABELS OF PRODUCTS ONLY SERVE TO
a. DISTINGUISH ONE PRODUCT FROM ANOTHER
b. MEET BFAD REQUIREMENTS
c. IMPART ELEGANCE
d. COMPLY WITH DOH REQUIREMENTS
a. DISTINGUISH ONE PRODUCT FROM ANOTHER
THE PRODUCT INSERTS FOR MANY DRUG PRODUCTS CONTAIN STATEMENTS. WHICH LEAST SERIOUS TO MOST SERIOUS: OF THE FOLLOWING SEQUENCES LIST THE THREE (3) TYPES OF CAUTIONS IN THE ORDER OF
A. CONTRAINDICATION, PRECAUTION, WARNING
B. PRECAUTION, WARNING, CONTRAINDICATION
C. WARNING, CONTRAINDICATION, PRECAUTION
D. CONTRAINDICATION, WARNING, PRECAUTION
B. PRECAUTION, WARNING, CONTRAINDICATION
FIFO REFERS TO:
A. PROTECTION
B. QUARANTINED MATERIALS
C. STOCK ROTATION
D. NOTA
C. STOCK ROTATION
AN ESTABLISHMENT ENGAGED IN OPERATIONS INVOLVED IN THE PRODUCTION OF DRUGS, INCLUDING PREPARATION PROCESSING, FILLING, PACKING, REPACKING & EMPHASIS LABELLING IN VIEW OF STORAGE, DISTRIBUTION OR SALE OF THE PRODUCT:
A. DRUG DISTRIBUTOR
B. DRUG TRADER
C. DRUG MANUFACTURER
D. NOTA
C. DRUG MANUFACTURER
IF YOU ARE A Q.C INSPECTOR, WHAT CRITICAL DEFECT IF FOUND SHOULD STOP THE PACKAGING LINE OPERATION & COULD BE PROCESSED IF RESULTS OF INVESTIGATION ARE SATISFACTORY:
A. INVERTED LABEL
B. WRONG LABEL
C. SMEARED LABEL
D. MISALIGNED LABEL
B. WRONG LABEL
A YELLOW STICKER IS USUALLY ATTACHED TO;
A. APPROVED FOR USE
B. REJECTED MATERIALS
C. QUARANTINED MATERIALS
D. RETURNED GOODS
C. QUARANTINED MATERIALS
REFERS TO THE ACT OF HOLDING OFF MATERIALS FOR USE OR A PRODUCT FOR PACKAGING OR DISTRIBUTION BY PHYSICALLY SETTING IT APART
A. REJECTED
B. REWORKING
C. IN-PROCESS
D. QUARANTINE
D. QUARANTINE
ALL SUBSTANCE WHETHER ACTIVE OR EXCIPIENTS THAT ARE EMPLOYED IN THE PROCESSING OF A FINISHED PRODUCT.
A. STARTING MATERIALS
B. FINISHED MATERIAL
C. INTERMEDIATE
D. RAW MATERIALS
D. RAW MATERIALS
ASSURING THE STABILITY OF THE DOSAGE FORMS DURING TRANSPORT & STORAGE, THE LABEL SHALL INDICATE
A. EXPIRY DATE
B. STORAGE CONDITION
C. CONCENTRATION OF THE DRUG SUBSTANCE
D. NOTA
B. STORAGE CONDITION
TABLET WEIGHT IS DETERMINED BY:
A. VOLUMETRIC FILL OF THE DISC
B. PRESSURE DURING COMPRESSION
C. AMOUNT & NATURE OF BINDER
D. AOTA
A. VOLUMETRIC FILL OF THE DISC
RECORD CONTAINING THE FORMULATION, SOECIFICATIONS, MANUFACTURING PROCEDURES, QUALITY ASSURANCE REQUIREMENTS & LABELING OF A FINISHED PRODUCT
A. PRODUCTION BATCH RECORD
B. MASTER RECORD
C. MASTER FORMULA RECORD
D. DISTRIBUTION RECORD
B. MASTER RECORD
A PROMINENTLY PRINTED ELEMENT ON THE LABEL AS MANDATED BY LAW
A. BRAND NAME
B. RX SYMBOL
C. PHARMACOLOGIC CATEGORY
D. GENERIC NAME
D. GENERIC NAME
VEEGUM IS A/AN
A. ORGANIC GUM
B. SYNTHETIC GUM
C. CLAY
D. NON-IONIC SURFACTANT
C. CLAY
AN ANTEROOM WHICH SEPARATES FROM THE NON STERILE IS A/AN
A. LAL
B. AIRLOCK
C. HEPA
D. AOTA
B. AIRLOCK
FOAM A IN EMULSION IS PREVENTED
A. APPLY COMPRFESSED AIR
B. ADD ANTIFOAMING AGENT
C. ADD POLYETHYLENE
D. A & B
D. A & B
SODA LIME GLASS IS ALSO KNOWN AS
A. TYPE I
B. NP
C. TYPE III
D. TYPE II
C. TYPE III
THE MOST COMMONLY USED METHOD IN DETERMINING THE PARTICLE SIZE OF POWDER
A. COULTER COUNTER
B. SIEVE METHOD
C. MICROSCOPY
D. NOTA
C. MICROSCOPY
WHEN THE EMULSIFYING AGENT IS ADDED TO WATER FIRST TO FORM A MUCILAGE AND THE OIL IS SLOWLY INCORPORATED, THE METHOD USED IN PREPARING THE EMULSION IS CALLED
A. IN-SITU METHOD
B. FORBES BOTTLE METHOD
C. CONTINENTAL METHOD
D. ENGLISH METHOD
D. ENGLISH METHOD
THE DYE COMPONENT CONTAINED IN FD&C YELLOW #5 WHICH CAUSES ALLERGIC TYPE REACTIONS IN MANY PEOPLE.
A. SULFUR
B. RED MERCURIC IODIDE
C. TARTRAZINE
D. EOSIN
C. TARTRAZINE
UNEVEN DISTRIBUTION OF COLORS ON THE SURFACE OF TABLET IS:
A. PEELING
B. MOTTLING
C. CAPPING
D. LAMINATION
B. MOTTLING
METHOD OF TABLET MANUFACTURE FOR EASILY COMPRESSIBLE OR ADHESIVE INGREDIENTS IS
A. DIRECT COMPRESSION
B. DRY METHOD
C. WET METHOD
D. SLUGGING
A. DIRECT COMPRESSION
PRACTICAL METHOD OF DETERMINING TABLET HARDNESS:
A. PFIZER TESTER
B. RULE OF THUMB
C. EUREKA TESTER
D. MONSANTO TESTER
RULE OF THUMB
FOR COMPACTING THE MATERIALS IN THE TABLET MACHINE:
A. HOPPER
B. FEED FRAME
C. DIES
D. PUNCHES
D. PUNCHES
THE PARTIAL OR INCOMPLETE SEPARATION OF THE TOP OR BOTTOM CROWN OF TABLET FROM MAIN BODY.
A. CHIPPING
B. CAPPING
C. LAMINATION
D. PICKING
B. CAPPING
METHOD THAT WILL PRODUCE TABLETS OF BEST QUALITY
A. DIRECT COMPRESSION
B. WET GRANULATION
C. DRY GRANULATION
D. AOTA
B. WET GRANULATION
PURIFIED WATER THAT IS FREE FROM PYROGENS
A. PURIFIED WATER
B. DEIONIZED WATER
C. WATER FOR INJECTION
D. AOTA
D. AOTA
SLUGGING IS ONE OF THE STEPS IN
A. MOLDING
B. DIRECT COMPRESSION METHOD
C. SUGAR COATING
D. DRY GRANULATION METHOD
B. DIRECT COMPRESSION METHOD
AGGREGATES OF POWDERS WHICH ADHERE OR BOND TO EACH OTHER TO FORM LARGER PARTICLES:
A. POWDERS
B. MICROCAPSULES
C. PELLETS
D. GRANULES
D. GRANULES
SUBSTANCE THAT GLUE POWDER TOGETHER CAUSING THEM TO FORM GRANULES.
A. DILUENTS
B. BINDER
C. LUBRICANT
D. DISINFECTANT
B. BINDER
A SIMPLE SENSITIVE AND FAST TEST FOR PYROGENS USING THE AMOEBOCYTE OF THE HORSE SHOE CRAB:
A. PYROGEN TEST
B. LAL TEST
C. RABBIT TEST
D. CRAB TEST
B. LAL TEST
AN AGENT THAT ACTS BETWEEN SURFACES IN RELATIVE MOTION TO PREVENT FRICTION AND WEAR
A. DILUENT
B. BINDER
C. LUBRICANT
D. DISINTEGRANT
C. LUBRICANT
BUBBLE TEST MEASURE THE EFFICIENCY OF:
A. GLASS
B. PLASTICS
C. MEMBRANE FILTER
D. AIR FILTER
C. MEMBRANE FILTER
HEPA FILTERS ARE USED FOR FILTRATION OF
A. PARENTERALS
B. AIR
C. OPTHTALMICS
B. AIR
THE ATTIRE OR UNIFORM USED IN PARENTERAL PRODUCTION INCLUDE
A. COVER ALL
B. FACE MASKS & HEAD COVERS
C. BOOTS & GLOVES
D. AOTA
A. COVER ALL
TABLET GRANULATION CAN BE DRIED FASTER USING
A. GRANULATOR
B. OVEN
C. FLUID BED DRYER
D. SOLAR DRYER
C. FLUID BED DRYER
