PSMB - Manuf Flashcards
1
Q
the packaging, repacking or changing the container,
wrapper or label of any drug package in preparation for its
distribution from the manufacturer to the final user
A
MANUFACTURING PHARMACY
2
Q
Any organization or company involved in the
manufacture, importation, repacking and/or
distributions of drugs or medicines
A
DRUG ESTABLISHMENTS
3
Q
Type of Drug Manufacturer
-Prescription Drugs
A
Ethical M.
4
Q
Type of Drug Manufacturer
-Branded and Generic
A
Proprietary/Generic M.
5
Q
Type of Drug Manufacturer
-Vaccine, Toxoid, Anti-sera, Biotechnology
A
Biologicals M.
6
Q
Type of Drug Manufacturer
-Drug used for animals
A
Veterinary Products M.
7
Q
Type of Drug Manufacturer
-Active ingredient/Excipient
A
Medicinal Chemical M.
8
Q
Type of Drug Manufacturer
-Manufacturing Drugs for the Other company
A
Toll/Contract M. | Interphil
9
Q
Imports or exports raw materials, active ingredients or
finished products for its own use or for wholesale
distribution on whole sale basis
A
DRUG IMPORTER/EXPOERTER/DISTRIBUTOR
10
Q
registered owner of the drug product but subcontracts
toll manufacture of such products to a licensed manufacturer
A
DRUG TRADER
11
Q
May also engage in distribution and or marketing of products
A
DRUG TRADER
12
Q
A mechanism for determining and assigning duties to people in order to work effectively
A
ORGANIZATION
13
Q
Combination of manpower, money, machines, materials and methods so coordinated to fulfill an economic objective
A
BASIC ORGANIZATION
14
Q
Other name for Level 1 of Top Management
A
“Board of Trustees”
15
Q
Other name for Level 2 of Top Management
A
“President of the Company”
16
Q
Other name for Level 3 of Top Management
A
“Vice-Presidents, General Managers and Department Managers”
17
Q
Protects and makes the most effective use of the assets of
the company
A
Level 1
18
Q
General management of the business
Active planning, direction, coordination and control of the
business
A
Level 2
19
Q
Management of the major divisions/departments of the
company
A
Level 3
20
Q
3 Stages for Research
A
Preliminary
Applied
Clinical Research
21
Q
CGMP were first promulgated by the US Food and Drug Administration (FDA) in _____ ; and finalized in ____
A
1963 | 1979
22
Q
Chapter 21 of the Code of Federal Regulations Part 211
A
Current Good Manufacturing Practices (cGMP)
23
Q
System of quality assurance aimed at ensuring that
products are consistently manufactured to a quality
appropriate for intended use and is concerned with
manufacturing and quality control process and procedures
A
Current Good Manufacturing Practices (cGMP)
24
Q
- Philippine FDA mandated all
drug manufacturers to ensure strict and full compliance to the newly adopted PICS
A
FDA MC 2012
25
Filed for generic copies by competing companies following expiration of patent term protection.
ANDA or Abbreviated New Drug Application
26
There are changes in synthesis, formulation, analytical standards, containers, and labeling of drug
products.
SNDA or Supplemental New Drug Application
27
Part of quality assurance which ensures that medicinal
products are consistently produced and controlled to the
quality standards appropriate to their intended use.
AO43 s. 1999
28
device that holds a drug and is or may be in direct
contact with the drug
Container
29
protects against extraneous solids and liquids, loss of drug under
ordinary conditions of handling, shipment, storage and
distribution
WELL-CLOSED CONTAINER
30
protects from extraneous solids, liquids or vapors, from loss of drug
and from efflorescence, deliquescence or evaporation
TIGHT CONTAINER
31
impervious to air or any other gases under ordinary conditions of
handling, shipment, storage and distribution generally sterile
HERMETIC CONTAINER
32
protects the contents from photochemical deterioration
amber, opaque, blue
LIGHT RESISTANT CONTAINER
33
designed to hold a quantity of drug intended for
administration as a single dose
- sterility is not assured after opening
SINGLE-UNIT
34
- contains more than a single dose of the medication
MULTIPLE-UNIT
35
HRBSG
Highly Resistant Borosilicate Glass
Type I
36
TSLG
Treated Soda-Lime Glass
Type II
37
SLG
Soda-lime Glass
Type III
38
GPSLG
General Purpose Soda Lime Glass
NP
39
performed on ground/powdered glass to expose internal surface
* tests the leaching potential of the
glass
Powdered Glass Test
40
alkali titrated with 0.02 N sulfuric acid
Powdered Glass Test
41
exposure of the glass with sulfur
dioxide at 121ºC
WATER ATTACK TEST
42
does not apply to a single material but rather to a
vast number of materials each developed to have
desired features
PLASTIC
43
Type of plastic that is squeezy
Thermoplastic
44
Type of plastic that is firm and rigid
Thermoset
45
Plastic Material
-cannot be autoclave
PE
46
Plastic Material
-for beverages
-have transparency and luster
PET
47
Plastic Material
-autoclavable
PP
48
Plastic material
-Rigid & good clarity
-Blister packaging
PVC
49
-- one that is difficult for most children under 5 years of age to open or gain access to the contents or obtain a harmful amount of the contents
-- based on the principle that a young child is unlikely to coordinate
two or more separate actions to achieve a successful opening
Child-Resistant Container
50
-- uses an indication or barrier to entry that is distinctive by design, or
must employ an identifying characteristic which if breached or missing can reasonably be expected to provide visible evidence to consumers that tampering has occurred
-- film wrappers, blister/strip packs, bubble packs, shrink seals/bands,
foil, paper or plastic pouches, bottle seals, tape seals, breakable caps,
sealed tubes, sealed cartons, aerosol containers, cans
Tamper-Resistant container
51
Provides additional hermetic seal
LINER
52
For tamper resistance
Inner Seal
53
Hermetic seals for vials
Rubber
Stopper
54
Prevent damage during shipment
Coil
55
Absorbs moisture
Desiccant
56
-- NON-POTENT
-- BLOCK AND DIVIDE
-- NOT INDIVIDUAL DOSE
-- WIDE MOUTH
BULK
57
-- POTENT
-- GEOMETRIC DILUTION
-- INDIVIDUAL DOSE
DIVIDED
58
BULK POWDER AKA
DODI-TAD
59
DIVIDED POWDER AKA
CHARTULA
60
absorbs moisture, but does not dissolve
HYGROSCOPIC
61
absorbs moisture and
eventually dissolves
DELIQUESCENT
62
releases water of crystallization
EFFLORESCENT
63
releases carbon dioxide gas in water
EFFERVESCENT
64
Particle size reduction
COMMINUTION
65
A finishing method for hard gelatine capsules, wherein a polyurethane or cheese cloth material lines the polishing pan. The liner is used to trap removed dust, imparting gloss to capsules;
Pan Polishing
66
-- aggregates of powders that adhere or bond to each other
to form larger unit particles
GRANULES
67
WET GRANULATION AKA
WET MASSING
68
A method of tablet production
wherein a granulation solution is
sprayed onto the suspended
particles which would then be
dried rapidly in the suspending
air
FLUID BED GRANULATION
69
process in which primary powder particles are made to adhere to form larger, multiparticle entities
GRANULATION
70
a multistep process used to make uniformly spherical particles (for controlled release application
SPHERONIZATION
71
particles are aggregated using high pressure
Dry Granulation
72
formation of large tablet is called
slug
73
particles that pass
through sieve 20 and are
retained at sieve 40
Good Granules
74
Particles that pass sieve 40
Fines
75
particles that pass
through sieve 20 and are
retained at sieve 40
GOOD GRANULES
76
particles that pass sieve 40
FINES
77
Use glidants, lubricants and antiadherents
Use of flow activators (GAL)
78
Hard Gelatin Capsule AKA
Dry Filled Capsule
79
HGC moisture content
12-16%
13-15%
80
In HGC, pegs are made of ____ in a melted gelated mixture
Manganese bronze
81
Shell is composed of Gelatin, water, sugar, colorants, 0.15% sulfur
dioxide, titanium dioxide
HGC
82
SGC moisture content
5-8% | 6-10%
83
rendered plasticlike with the addition
of plasticizers
(glycerin or sorbitol)
SGC
84
filled with pumpable
solutions, suspensions,
pasty material or powders
formed and sealed in a
single manufacture process
SGC
85
Separation of Top & Bottom
Capping
86
Separation of small portion (friability)
Chipping
87
Separation of several layers
Lamination
88
Removal of Top Layer
Picking
89
Removal of small portion of liquid
Flaking
90
Adhesion of material to the ** wall
Sticking
91
Reduce adhesion of film from the tablet due to improper drying
Blistering
92
Reduce adhesion wirh many blister
Wrinkling
93
Roughness of tablet surface
Orange-Peel
94
Filling in the score line
Bridging
95
Filling in the score line
Bridging
96
Formation of oil film droplets of liquid
Sweating
97
Dull migration of plasticizer
Blooming
98
Migration of other ingredients
Spotting
99
Migration of color
Mottling
100
Preservative
0.15% sulfur dioxide
101
Ex of Opacifying agent
Titanium dioxide
102
load in grams required to push a standard set distance into a
prepared gelatin gel (6.66%) soln at 10 deg c
*Bloom Strength
103
LOADS THE
GRANULE
Hopper
104
DIRECTS GRANULES
FROM THE HOPPER TO THE SIDE
Feed shoe
105
- COMPRESS
GRANULES INTO TAB
Punch
106
GUIDES THE
MOVEMENT OF UPPER
AND LOWER PUNCHES
Cam tracks
107
- CONTROL THE
SIZE AND SHAPE OF
THE TABLET
DIE
108
Add necessary bulk to the formulation
Diluents / Fillers
109
Promotes adhesion of the particles
Binders / Adhesives
110
Promotes breakup of the tablet after administration
Disintegrants
111
Improve flow properties of granules
Glidants
112
Reduces friction during ejection of tablets from the machine
to prevent picking
Lubricats
113
Prevents tablet ingredients from sticking to punches and dies
during the production
Anti-adherents
114
Agent capable of holding the molecule onto their
surfaces
Adsorbents
115
for aesthetic purposes and product identification
can be natural or synthetic
Coloring Agents
116
Coloring Agent
Water soluble
DYES
117
Coloring Agent
Water insoluble
LAKES
118
oils or dry powders are used in formulations
color, odor and flavor must complement one
another
Flavoring Agents
119
Natural Sweetening Agents
Sucrose
Honey
Stevia
120
causes cancer in rats, unproven safety
FD & C Red #2 (amaranth)
121
found in maraschino cherries and ingested drugs;
only used in external drugs and cosmetics
FD & C Red #4
122
causes allergic type reaction in many people
FD&C Yellow No. 5 (tartrazine)
123
D & C Red No. 22
Eosine
124
FD & C #6
Sunset Yellow
125
FD & C Blue No. 2
Brilliant Blye
126
Allura Red
FD & C Red No. 40
127
CAt
Avette
128
Sperm whale
Ambergris
129
Deer
Musk
130
successive addition of sucrose-based solutions to a tablet
core
Sugar-coating
131
3 Processes of Sugar coating
1. Pan Coating
2. Pan Spraying
3. Pan Suspension
132
Most widely used process in sugar-coating
Pan coating
133
FOR COMPONENTS EASILY
AFFECTED BY WATER
Sealing / Waterproofing
134
IMPROVE BOND BETWEEN SUGAR COAT
AND TABLET CORE
Subcoating
135
COMPLETE ROUNDING OFF
Syruping / Smoothing
136
ESTABLISHING COLOR BASE
GLOSSING
137
BUILD A SOLID COLOR BASE RAPIDLY
HEAVY SYRUPING-
138
TO ATTAIN APPROPRIATE COLOR
REGULAR SYRUPING
139
TO ATTAIN FINAL SMOOTHNESS
Finishing
140
imprinted with a mark BELOW the surface
DEBOSSED
141
imprinted with a mark ABOVE the surface.
EMBOSED
142
FOR SHEEN OR GLOSS
Polishing
143
The process of placing a thin, skin-tight coating of a plasticlike material over a tablet core
Film-coating
144
- About 2-5% increase in thickness only
Film-coating
145
PRODUCES SMOOTH THIN FILM
Film Former
146
PROVIDES WATER SOLUBILITY / PERMEABILITY TO THE
FILM TO ENSURE PENETRATION BY BODY FLUIDS
Alloying Substance-
147
PRODUCES FLEXIBILITY + ELASTICITY DURING APPLICATION
Plasticizer
148
ENHANCE SPREADABILITY OF THE FILM DURING APPLICATION
Surfactant
149
TO ENHANCE AESTHETIC QUALITIES OF THE COAT
Opaquant & Colorant
150
ENHANCE ACCEPTABILITY OF THE TABLET BY
THE PX
Sweetener, Flavor and Aroma
151
- PRODUCES LUSTER TO TABLET
Glossant
152
ALLOWS THE SPREAD OF OTHER CMPD OVER THE
TABLET WHILE ALLOWING RAPID EVAP TO PERMIT AN EFFECTIVE YET
SPEEDY OPERATION
Volatile Solvent
153
-Designed to resist dissolution in the stomach but dissolve in
the less acidic environment of the small intestines
ENTERIC COATING
154
A capsule composed of hard gelatin shell
containing hundreds of tiny coated
beads/pellets of drugs for sustained release.
SPANSULE
155
End of the body-producing peg is
tapered but the cap-making peg is
rounded. Used by Eli Lilly
PULVULES
156
- Ends of both bodies and cap
are highly tapered/narrowed.
Used by Smith Kline
Beecham.
SPANSULE
157
This is a distinctive looking capsule because
of the sealing with a colored band of gelatin.
This is used by Parke-Davis.
KAPSEAL
158
- The rim of the capsule body is not straight but tapered slightly.
This eliminates splitting of the joined capsule.
CONI-SNAP
159
A pH-sensitive, non-digestible radiofelemettric device used as
a nonradioactive means of measuring gastric pH, gastric
residence time and gastric emptying time of solid dosage
forms is called________.
HIEDELBERG
160
is the disfiguration of the core tablet
Tablet erosion
161
Slow form of sticking
Filming
162
- Defect of film coating whereby volcanic like
craters appear
Cratering
163
Whitish specks/ haziness in the film
Blushing
164
Due to rapid expansion of tablet
Cracking
165
- Sunken center formation
Rocker bottom
166
are dispersed systems in
which the dispersed phase is
composed of small globules
of a liquid distributed
throughout a vehicle in
which it is immiscible
Emulsion
167
acts as the bridge between the
2 immiscible phases
Emulsifier
168
protects the emulsified lipids
which are susceptible to oxidation
ex. BHA, BHT, tocopherol, ascorbic
acid, EDTA
Antioxidant
169
Oil phase containing oil-soluble ingredients is heated at
about
5-10ºC
170
An equipment the mixes the components of emulsions by
means of various impellers on shafts, which are placed
directly into the system to be emulsified;
colloid mills
171
This equipment produces finely divided particles by
spraying a mist of liquid through a heated chamber, drying
immediately and collecting the dried powders in a clean
receptacle;
Homogenizers
172
pressurized dosage forms designed to deliver
drug systematically or topically with the aid of liquefied
or propelled gas
AEROSOL
173
active ingredient combine with
excipients
Product concentrate–
174
act as a solvent and diluent
Propellant
175
– provides a rapid and convenient means for releasing
the contents from a pressurized container; button that activates
the system
Actuator
176
– expels the contents
from the container; regulate the
flow of product from container
Valve
177
Part of the usual aerosol
valve assembly that supports the
actuator and delivers the
formulation in the proper form
Stem
178
– the tube that delivers the content
Dip tube –
179
Placed snugly with the stem,
prevents leakage of the formulation when the
valve is closed.
Gasket
180
Part of the usual aerosol
valve assembly that is attached to the
aerosol can or container and hold the valve
in place.
Mounting cup –
181
Holds the gasket in place and is
the mechanism by which the actuator
retracts when pressure is released,
returning the valve to the closed
position
Spring
182
most stringent control
Compounding area
183
“heart” of production area
Aseptic filling area
184
storage while waiting for QC results
Quarantine area
185
Quarantine area
Airlock
186
Test the integrity of strips, blisters and bottles
Operation based on vacuum
LEAKERS TEST
