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
