ddp part 3 cGMP Flashcards
Established by the Food and Drug Administration
(FDA) to ensure the minimum standards are met
for drug product quality
GMP
GMP for Finished Pharmaceuticals
General provisions:
Scope and Definition
Organization and
Personnel
Building and Facilities
Equipment
Control of
Components,
Containers and
Closures
Production and
Process control
Packaging and labeling
control
Holding and
Distribution
Laboratory controls
Records and Reports
Returned and Salvaged drugs
Information technology and Automation
The package and closure system must be shown effective for the
particular product for which it is intended:
Physicochemical properties
Light-transmission for glass or plastic
Drug compatibility
Leaching and/or migration
Vapor transmission for plastic
Moisture barrier
Toxicity for plastics
Valve, actuator, metered dose, particle size, spray
characteristics, and leaks for aerosols
Sterility and permeation for parenteral
Drug stability
Packaging, Labeling and Storage
of Pharmaceuticals
The package and closure system must be shown effective for the
particular product for which it is intended
holds the article and is
or maybe in direct contact with the article
Container
that which is in direct
contact with the article at all times.
Immediate container
protects the contents
from extraneous solids and from loss of the article
under ordinary conditions of handling, shipment,
storage, and distribution
Well-closed container
protects the contents from the
contamination by extraneous liquids, solids, or
vapors, from loss of the article, and from
efflorescence, deliquescence, or evaporation under
the ordinary or customary conditions of handling,
shipment, storage, and distribution and is capable
of tight re-closure.
tight container
is impervious to air or any other gas
under the ordinary or customary conditions of handling,
shipment, storage, and distribution.”
hermentic container
generally use to hold
preparations intended for injection or parenteral
administration.
sterile hermetic containers
one that holds a quantity of drug
intended as a single dose and when opened cannot be
resealed with assurance that sterility has been maintained.
single-dose container
fusion-sealed ampuls, pre-filled syringes and
cartridges
single-dose container
is a hermetic container
that permits withdrawal of successive portions of the contents without changing the strength or endangering the quality of purity of the remaining
portion.
multiple-dose container
is designed to hold a
quantity of drug intended for administration as a
single dose promptly after the container is opened
A single-unit package is termed a unit dose
package
single-unit container
contain more than a
single unit or dose of the medication
multiple-unit container
