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Misconceptions & its Cross-Pollination
An Instrument to Damage Evolution Process of
Pharmaceutical Development
Roohi B. ObaidCivil Service Officer, Member, ISPE, PDA
26 March 2017
If life of a raw
material is more,
the shelf life of
drug product will
be more
If life of a raw
material is less,
the shelf life of
drug product will
be more
?
?
?
1
2
If life of a raw
material is more,
the shelf life of
drug product will
be more
If life of a raw
material is less,
the shelf life of
drug product will
be more
If life of a raw
material is more,
the shelf life of
drug product will
be less
?
?
?
?
1
2
3
Raw Material
Drug Product
StabilityLets resolve
We know
Both DS & DP
have their own
manufacturing
& own
life/period
Life of raw material will
increase life of product
Life of raw material will
decrease life of product
Batch 1
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2015
Batch 2
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2018
Batch 1
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2015
Batch 2
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2018
Different Same BothExpiry may be
Batch 1
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2015
Batch 2
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2018
Expiry may be Different Same Both
Batch 1
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2015
Batch 2
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2018
Different Same BothExpiry may be
Suppose life is 10 days best to use,
impact will be observed everyday
If converted to pickle, life of product
is more likely to increase many fold
A January 2015
B March 2018
C February 2017
D November 2019
E April 2015
Raw material & their Expiries
What will
be its expiry
now?
Drug
product
Mfg started
in Dec 2014
Lets try to resolve
Date of Manufacturing & Date of Expiry
Drug
Substance
Processed
(pellets)
Drug
Product
Can expiry of Pellets (Drug) remain same upon
converting into finished drug product via primary
packaging
Scenario
A of B
Do humidity and temperature have an impact on Pellets (Drug)?
Do humidity & temperature have relation with Primary Packaging?
Does this relation has an impact on shelf life?
1
2
3
Do humidity and temperature have an impact on Pellets (Drug)?
Do humidity & temperature have relation with Primary Packaging?
Does this relation has an impact on shelf life?
1
2
3
Yes
Yes
Yes
Drug Substance
PelletsFinished Product
X year Y Year Z Year
Conclusively based on Study
Nothing More, Nothing Less
Can expiry of Bulk Powder (Ceftriaxone Sodium)
remain same upon filling into Unit Dosage Form
Packaging as Finished Drug Product
Scenario
B of B
Do humidity and temperature have an impact on Bulk Powder (Drug)?
Do humidity & temperature have relation with Primary Packaging?
Does this relation has an impact on shelf life?
1
2
3
Do humidity and temperature have an impact on Bulk Powder (Drug)?
Do humidity & temperature have relation with Primary Packaging?
Does this relation has an impact on shelf life?
1
2
3
Yes
Yes
Yes
Drug Substance
Finished Product
X year Y Year
Conclusively based on Study
Nothing More, Nothing Less