All cards
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critical quality standards that are proposed
and justified by the manufacturer and
approved by the regulatory authorities as
conditions of approval.
and justified by the manufacturer and
approved by the regulatory authorities as
conditions of approval.
checklist
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It establishes the set of criteria to which a
drug substance, drug product or materials
at other stages of its manufacture should
conform to be considered acceptable for
its intended use.
drug substance, drug product or materials
at other stages of its manufacture should
conform to be considered acceptable for
its intended use.
checklist
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means that the drug substance and
drug product, when tested according
to the listed analytical procedures,
will meet the acceptance criteria
drug product, when tested according
to the listed analytical procedures,
will meet the acceptance criteria
Conformance to Specification
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should be presented for each procedure
and each acceptance criterion included
and each acceptance criterion included
Justification of Specification
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should refer to relevant development
data, pharmacopeial standards, test data
for drug substances and drug products
used in toxicology and clinical studies,
and results from stability studies
data, pharmacopeial standards, test data
for drug substances and drug products
used in toxicology and clinical studies,
and results from stability studies
Justification of Specification
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qualitative statement of the state & color of the new drug substance
description
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be able to discriminate between compounds of closely related
structure which are likely to be present
structure which are likely to be present
identification
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A specific, stability-indicating procedure should be included to
determine the content of the new drug substance
determine the content of the new drug substance
assay
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the capability of a particular formulation in a
specific container/closure system to remain
within its physical, chemical, microbiological,
toxicological, protective and informational
specifications
specific container/closure system to remain
within its physical, chemical, microbiological,
toxicological, protective and informational
specifications
drug stability
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degradation of API in product resulting in less than $o%/ drug as daimed on label
Loss of Active
Ingredient
Ingredient
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loss of vehide perfusion bags sometimes allow solvent to escape & evaporate so that the product within the bag shows increase in concentration
Inarease in
concentration of
active ingredient
concentration of
active ingredient
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Changes in rate and extent of
absorption on storage
absorption on storage
Alteration In
Bioavailability
Bioavailability
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Loss of contents as a function of
time
time
Loss of content
umiformity
umiformity
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Increase in number of viable microorganisms already present in the product; contamination because of compromised package integrity during distribution
Dedine of
microbiological.
status
microbiological.
status
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Speckling caused by the
interaction of the drug container containing amine group with a minor component in the lactose resulting in the formation of a chromatophore
interaction of the drug container containing amine group with a minor component in the lactose resulting in the formation of a chromatophore
lost of pharmaceutical elegance and patient acceptability
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the capability of a particular formulation
in a specific container/closure system to
remain within its physical, chemical,
microbiological, toxicological, protective
and informational specifications
in a specific container/closure system to
remain within its physical, chemical,
microbiological, toxicological, protective
and informational specifications
long term STABILITY TESTING
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data is collected at an appropriate
frequency such that a trend analysis is
able to distinguish instability from day-today ambiguity
frequency such that a trend analysis is
able to distinguish instability from day-today ambiguity
long term STABILITY TESTING
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