Never be Confused, Resolve the Issues

1. Misconceptions & its Cross-Pollination
An Instrument to Damage Evolution Process of
Pharmaceutical Development
Roohi B. Obaid
Civil Service Officer, Member, ISPE, PDA
26 March 2017

2. Misconception Myth

4. Misconception 1 of 3

5. API
Batch
1
Batch
2
Batch
3
Batch
4

6. API
Expiry Expiry
FG
Mfg Mfg

7. API
Expiry Expiry
FG
Mfg Mfg
Relationship ???

8. API
Expiry Expiry
FG
Mfg Mfg
Relationship ???

9. If life of a raw
material is more,
the shelf life of
drug product will
be more
?
1

10. 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

11. 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

12. Lets resolve
We know
Both DS & DP
have their own
manufacturing
& own
life/period

13. Raw
Material
Drug
Product
StabilityLets resolve
We know
Both DS & DP
have their own
manufacturing
& own
life/period

14. Expiry/retest date of
Drug Substance Expiry date of
Drug Product
Relationship ?

15. Expiry/retest date of
Drug Substance Expiry date of
Drug Product
Relationship ?
Yes/ No

16. Life of raw material will
increase life of product

17. Life of raw material will
increase life of product
Life of raw material will
decrease life of product

18. Batch 1
Inj. Gentamicin is
manufactured in Jan
2015 in which expiry of
used API was Feb 2015

19. 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

20. 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

21. 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

22. 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

23. Both are
Independent

24. Both are
Independent
Both based
on study

25. Both are
Independent
Both based
on study
There is NO
relationship

26. Lets make Science visible to catch
Philosophy and Logic behind the
Principle of Stability

27. Take a look at Scenario “A of B”

29. Jan to Dec 2015

30. Jan to Dec 2015
Feb
2015

31. Jan to Dec 2015
Feb
2015
May
2015

32. Jan to Dec 2015
Feb
2015
May
2015
Aug
2015

33. Jan to Dec 2015
Feb
2015
May
2015
Aug
2015
Nov
2015

34. Saturday Monday
TuesdayFriday

35. Take a look at Scenario “B of B”

36. Whose life is greater & what is maximum life

37. 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

38. 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

39. Misconception 2 of 3

40. Lets try to resolve
Date of Manufacturing & Date of Expiry
Drug
Substance
Processed
(pellets)
Drug
Product

41. Can expiry of Pellets (Drug) remain same upon
converting into finished drug product via primary
packaging
Scenario
A of B

42. 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

43. 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

44. Drug
Substance
Pellets
Finished
Product
X year Y Year Z Year
Conclusively based on Study
Nothing More, Nothing Less

47. Can expiry of Bulk Powder (Ceftriaxone Sodium)
remain same upon filling into Unit Dosage Form
Packaging as Finished Drug Product
Scenario
B of B

48. 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

49. 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

50. Drug
Substance
Finished
Product
X year Y Year
Conclusively based on Study
Nothing More, Nothing Less