PSMB - Manuf Flashcards
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
MANUFACTURING PHARMACY
Any organization or company involved in the
manufacture, importation, repacking and/or
distributions of drugs or medicines
DRUG ESTABLISHMENTS
Type of Drug Manufacturer
-Prescription Drugs
Ethical M.
Type of Drug Manufacturer
-Branded and Generic
Proprietary/Generic M.
Type of Drug Manufacturer
-Vaccine, Toxoid, Anti-sera, Biotechnology
Biologicals M.
Type of Drug Manufacturer
-Drug used for animals
Veterinary Products M.
Type of Drug Manufacturer
-Active ingredient/Excipient
Medicinal Chemical M.
Type of Drug Manufacturer
-Manufacturing Drugs for the Other company
Toll/Contract M. | Interphil
Imports or exports raw materials, active ingredients or
finished products for its own use or for wholesale
distribution on whole sale basis
DRUG IMPORTER/EXPOERTER/DISTRIBUTOR
registered owner of the drug product but subcontracts
toll manufacture of such products to a licensed manufacturer
DRUG TRADER
May also engage in distribution and or marketing of products
DRUG TRADER
A mechanism for determining and assigning duties to people in order to work effectively
ORGANIZATION
Combination of manpower, money, machines, materials and methods so coordinated to fulfill an economic objective
BASIC ORGANIZATION
Other name for Level 1 of Top Management
“Board of Trustees”
Other name for Level 2 of Top Management
“President of the Company”
Other name for Level 3 of Top Management
“Vice-Presidents, General Managers and Department Managers”
Protects and makes the most effective use of the assets of
the company
Level 1
General management of the business
Active planning, direction, coordination and control of the
business
Level 2
Management of the major divisions/departments of the
company
Level 3
3 Stages for Research
Preliminary
Applied
Clinical Research
CGMP were first promulgated by the US Food and Drug Administration (FDA) in _____ ; and finalized in ____
1963 | 1979
Chapter 21 of the Code of Federal Regulations Part 211
Current Good Manufacturing Practices (cGMP)
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
Current Good Manufacturing Practices (cGMP)
- Philippine FDA mandated all
drug manufacturers to ensure strict and full compliance to the newly adopted PICS
FDA MC 2012
Filed for generic copies by competing companies following expiration of patent term protection.
ANDA or Abbreviated New Drug Application
There are changes in synthesis, formulation, analytical standards, containers, and labeling of drug
products.
SNDA or Supplemental New Drug Application
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
device that holds a drug and is or may be in direct
contact with the drug
Container
protects against extraneous solids and liquids, loss of drug under
ordinary conditions of handling, shipment, storage and
distribution
WELL-CLOSED CONTAINER
protects from extraneous solids, liquids or vapors, from loss of drug
and from efflorescence, deliquescence or evaporation
TIGHT CONTAINER
impervious to air or any other gases under ordinary conditions of
handling, shipment, storage and distribution generally sterile
HERMETIC CONTAINER
protects the contents from photochemical deterioration
amber, opaque, blue
LIGHT RESISTANT CONTAINER
designed to hold a quantity of drug intended for
administration as a single dose
- sterility is not assured after opening
SINGLE-UNIT
- contains more than a single dose of the medication
MULTIPLE-UNIT
HRBSG
Highly Resistant Borosilicate Glass
Type I
TSLG
Treated Soda-Lime Glass
Type II
SLG
Soda-lime Glass
Type III
GPSLG
General Purpose Soda Lime Glass
NP
performed on ground/powdered glass to expose internal surface
* tests the leaching potential of the
glass
Powdered Glass Test
alkali titrated with 0.02 N sulfuric acid
Powdered Glass Test
exposure of the glass with sulfur
dioxide at 121ºC
WATER ATTACK TEST
does not apply to a single material but rather to a
vast number of materials each developed to have
desired features
PLASTIC
Type of plastic that is squeezy
Thermoplastic
Type of plastic that is firm and rigid
Thermoset
Plastic Material
-cannot be autoclave
PE
Plastic Material
-for beverages
-have transparency and luster
PET
Plastic Material
-autoclavable
PP
Plastic material
-Rigid & good clarity
-Blister packaging
PVC
– 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
– 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
Provides additional hermetic seal
LINER
For tamper resistance
Inner Seal
Hermetic seals for vials
Rubber
Stopper
Prevent damage during shipment
Coil
Absorbs moisture
Desiccant
– NON-POTENT
– BLOCK AND DIVIDE
– NOT INDIVIDUAL DOSE
– WIDE MOUTH
BULK
– POTENT
– GEOMETRIC DILUTION
– INDIVIDUAL DOSE
DIVIDED
BULK POWDER AKA
DODI-TAD
DIVIDED POWDER AKA
CHARTULA
absorbs moisture, but does not dissolve
HYGROSCOPIC
absorbs moisture and
eventually dissolves
DELIQUESCENT
releases water of crystallization
EFFLORESCENT
releases carbon dioxide gas in water
EFFERVESCENT
Particle size reduction
COMMINUTION
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
– aggregates of powders that adhere or bond to each other
to form larger unit particles
GRANULES
WET GRANULATION AKA
WET MASSING
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
process in which primary powder particles are made to adhere to form larger, multiparticle entities
GRANULATION
a multistep process used to make uniformly spherical particles (for controlled release application
SPHERONIZATION
particles are aggregated using high pressure
Dry Granulation
formation of large tablet is called
slug
particles that pass
through sieve 20 and are
retained at sieve 40
Good Granules
Particles that pass sieve 40
Fines
particles that pass
through sieve 20 and are
retained at sieve 40
GOOD GRANULES
particles that pass sieve 40
FINES
Use glidants, lubricants and antiadherents
Use of flow activators (GAL)
Hard Gelatin Capsule AKA
Dry Filled Capsule
HGC moisture content
12-16%
13-15%
In HGC, pegs are made of ____ in a melted gelated mixture
Manganese bronze
Shell is composed of Gelatin, water, sugar, colorants, 0.15% sulfur
dioxide, titanium dioxide
HGC
SGC moisture content
5-8% | 6-10%
rendered plasticlike with the addition
of plasticizers
(glycerin or sorbitol)
SGC
filled with pumpable
solutions, suspensions,
pasty material or powders
formed and sealed in a
single manufacture process
SGC
Separation of Top & Bottom
Capping
Separation of small portion (friability)
Chipping
Separation of several layers
Lamination
Removal of Top Layer
Picking
Removal of small portion of liquid
Flaking
Adhesion of material to the ** wall
Sticking
Reduce adhesion of film from the tablet due to improper drying
Blistering
Reduce adhesion wirh many blister
Wrinkling
Roughness of tablet surface
Orange-Peel
Filling in the score line
Bridging
Filling in the score line
Bridging
Formation of oil film droplets of liquid
Sweating
Dull migration of plasticizer
Blooming
Migration of other ingredients
Spotting
Migration of color
Mottling
Preservative
0.15% sulfur dioxide
Ex of Opacifying agent
Titanium dioxide
load in grams required to push a standard set distance into a
prepared gelatin gel (6.66%) soln at 10 deg c
*Bloom Strength
LOADS THE
GRANULE
Hopper
DIRECTS GRANULES
FROM THE HOPPER TO THE SIDE
Feed shoe
- COMPRESS
GRANULES INTO TAB
Punch
GUIDES THE
MOVEMENT OF UPPER
AND LOWER PUNCHES
Cam tracks
- CONTROL THE
SIZE AND SHAPE OF
THE TABLET
DIE
Add necessary bulk to the formulation
Diluents / Fillers
Promotes adhesion of the particles
Binders / Adhesives
Promotes breakup of the tablet after administration
Disintegrants
Improve flow properties of granules
Glidants
Reduces friction during ejection of tablets from the machine
to prevent picking
Lubricats
Prevents tablet ingredients from sticking to punches and dies
during the production
Anti-adherents
Agent capable of holding the molecule onto their
surfaces
Adsorbents
for aesthetic purposes and product identification
can be natural or synthetic
Coloring Agents
Coloring Agent
Water soluble
DYES
Coloring Agent
Water insoluble
LAKES
oils or dry powders are used in formulations
color, odor and flavor must complement one
another
Flavoring Agents
Natural Sweetening Agents
Sucrose
Honey
Stevia
causes cancer in rats, unproven safety
FD & C Red #2 (amaranth)
found in maraschino cherries and ingested drugs;
only used in external drugs and cosmetics
FD & C Red #4
causes allergic type reaction in many people
FD&C Yellow No. 5 (tartrazine)
D & C Red No. 22
Eosine
FD & C #6
Sunset Yellow
FD & C Blue No. 2
Brilliant Blye
Allura Red
FD & C Red No. 40
CAt
Avette
Sperm whale
Ambergris
Deer
Musk
successive addition of sucrose-based solutions to a tablet
core
Sugar-coating
3 Processes of Sugar coating
- Pan Coating
- Pan Spraying
- Pan Suspension
Most widely used process in sugar-coating
Pan coating
FOR COMPONENTS EASILY
AFFECTED BY WATER
Sealing / Waterproofing
IMPROVE BOND BETWEEN SUGAR COAT
AND TABLET CORE
Subcoating
COMPLETE ROUNDING OFF
Syruping / Smoothing
ESTABLISHING COLOR BASE
GLOSSING
BUILD A SOLID COLOR BASE RAPIDLY
HEAVY SYRUPING-
TO ATTAIN APPROPRIATE COLOR
REGULAR SYRUPING
TO ATTAIN FINAL SMOOTHNESS
Finishing
imprinted with a mark BELOW the surface
DEBOSSED
imprinted with a mark ABOVE the surface.
EMBOSED
FOR SHEEN OR GLOSS
Polishing
The process of placing a thin, skin-tight coating of a plasticlike material over a tablet core
Film-coating
- About 2-5% increase in thickness only
Film-coating
PRODUCES SMOOTH THIN FILM
Film Former
PROVIDES WATER SOLUBILITY / PERMEABILITY TO THE
FILM TO ENSURE PENETRATION BY BODY FLUIDS
Alloying Substance-
PRODUCES FLEXIBILITY + ELASTICITY DURING APPLICATION
Plasticizer
ENHANCE SPREADABILITY OF THE FILM DURING APPLICATION
Surfactant
TO ENHANCE AESTHETIC QUALITIES OF THE COAT
Opaquant & Colorant
ENHANCE ACCEPTABILITY OF THE TABLET BY
THE PX
Sweetener, Flavor and Aroma
- PRODUCES LUSTER TO TABLET
Glossant
ALLOWS THE SPREAD OF OTHER CMPD OVER THE
TABLET WHILE ALLOWING RAPID EVAP TO PERMIT AN EFFECTIVE YET
SPEEDY OPERATION
Volatile Solvent
-Designed to resist dissolution in the stomach but dissolve in
the less acidic environment of the small intestines
ENTERIC COATING
A capsule composed of hard gelatin shell
containing hundreds of tiny coated
beads/pellets of drugs for sustained release.
SPANSULE
End of the body-producing peg is
tapered but the cap-making peg is
rounded. Used by Eli Lilly
PULVULES
- Ends of both bodies and cap
are highly tapered/narrowed.
Used by Smith Kline
Beecham.
SPANSULE
This is a distinctive looking capsule because
of the sealing with a colored band of gelatin.
This is used by Parke-Davis.
KAPSEAL
- The rim of the capsule body is not straight but tapered slightly.
This eliminates splitting of the joined capsule.
CONI-SNAP
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
is the disfiguration of the core tablet
Tablet erosion
Slow form of sticking
Filming
- Defect of film coating whereby volcanic like
craters appear
Cratering
Whitish specks/ haziness in the film
Blushing
Due to rapid expansion of tablet
Cracking
- Sunken center formation
Rocker bottom
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
acts as the bridge between the
2 immiscible phases
Emulsifier
protects the emulsified lipids
which are susceptible to oxidation
ex. BHA, BHT, tocopherol, ascorbic
acid, EDTA
Antioxidant
Oil phase containing oil-soluble ingredients is heated at
about
5-10ºC
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
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
pressurized dosage forms designed to deliver
drug systematically or topically with the aid of liquefied
or propelled gas
AEROSOL
active ingredient combine with
excipients
Product concentrate–
act as a solvent and diluent
Propellant
– provides a rapid and convenient means for releasing
the contents from a pressurized container; button that activates
the system
Actuator
– expels the contents
from the container; regulate the
flow of product from container
Valve
Part of the usual aerosol
valve assembly that supports the
actuator and delivers the
formulation in the proper form
Stem
– the tube that delivers the content
Dip tube –
Placed snugly with the stem,
prevents leakage of the formulation when the
valve is closed.
Gasket
Part of the usual aerosol
valve assembly that is attached to the
aerosol can or container and hold the valve
in place.
Mounting cup –
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
most stringent control
Compounding area
“heart” of production area
Aseptic filling area
storage while waiting for QC results
Quarantine area
Quarantine area
Airlock
Test the integrity of strips, blisters and bottles
Operation based on vacuum
LEAKERS TEST
