Hands on training given to a group of pharmaceutical professionals

1. Recall & Returns; Fundamental Element of GMP
Will it work when required?
A Regulatory Perspective
Roohi B. Obaid Dec 1st 2018

3. It is based on experience and explanations reflects the views and
understanding of presenter & may not be construed to represent
the views or policies of organization or association to which
speaker has ties
Disclaimer

4. Return of distributed good
from market
Market includes distributor
Market includes pharmacies
Market includes consumer
Risk will scratch the word
market
Re call

7. R
E
C
A
L
L
Effective Product

8. Obligation or Option
Recall
For Mfg
?

9. Authority or Responsibility
Recall
For RA
?

10. Failure to initiate
voluntary recall for which
recall is necessary,
manufacturer may face a
series of legal
consequences
Remember

11. Regulatory Authority may
order for initiation of
recall
Don’t wait

12. Within 24 hours if
probability of causing
human life at risk
Report
Immediately

13. Regulatory authority &
allow influence to make
recall more effective and
protect your own
credibility
Do Engage

14. Don’t hesitate to issue
public warning, when
required
Powerful Strategy

15. Monitor efficiency
religiously
Don’t close recall on
assumptions unless
sufficient evidence is
available to verify
Recall Clock

16. Monitor efficiency
religiously
Don’t close recall on
assumptions unless
sufficient evidence is
available to verify
Maintain Record

17. A damage that does not have
impact on quality of product
may be allowed to reenter in
the market after its re-dressing
or cosmetic make up.
Re-dressing does not mean
exposure of drug. It means at
the level of secondary
container that was not included
in stability studies.Return

18. I
II
III
Class of Recall

19. Lets imagine if something goes
wrong. Your product is
distributed all across Pakistan
even to some other countries.
How would you assure that
your recall system will work?
Recall
Qualification

20. Product information
Reason of recall
What to do
Recall Notice

21. What it means?
How much it is important?
What are the obligations?
Recall

22. Particles are reported visible in
multiple lots of your particular
injections
Multiple reports from nurses,
pharmacists & physicians
How would you proceed. Write
step by step
Complaint

23. Cracking of vials is reported in
some units of different lots of
your multiple injections
Multiple reports from nurses,
pharmacists & physicians
How would you proceed. Write
step by step
Complaint

24. Meningitis is observed in a
patient who was healthy and
was administered single IV
dose of your product
alendronate sodium a day
before.
How would you proceed. Write
step by step
Complaint

25. A sharp decrease in potency
observed at 12 month of life
during annual stability study.
The shelf life is 3 years.
How would you proceed. Write
step by step
Observation

26. Pharmacy reported that your
strips lack of two tablets and
instead of 10 tablets, strip
contain 8 tablets.
How would you proceed.
Complaint

27. Pharmacy reported that your
strips of 28 tablets in which
first 4 tablets are supposed to
be placebo and required to be
administered in first 4 days are
wrongly packed in the strip as
last 4 tablets, that give sound of
consumption for last 4 days.
How would you proceed.Complaint

28. People are dying with
unknown drug in a particular
hospital. It is confirmed that
your drug was also included in
the prescription of died
patients.
How would you respond?
News

29. Severe anaphylactic shock is
reported after administration of
your IV Cephalosporin drug in
3 different healthcare facilities.
Same facilities experienced
similar anaphylactic shock with
other brands of similar
generics.
How would you respond?Complaint

30. An unpleasant smell is
experienced by the consumer
upon opening of glass bottles
containing your drug. It is your
old drug and this complaint has
newly emerged.
How would you respond?
Complaint

31. Recall of another company was
initiated due to potential
contamination of penicillin
with material used for their
formulation. You do purchase
same material of same
manufacturing site through
another vendor.
How would you respond?Complaint

32. A product has two strengths
25 mg & 125 mg.
Label mix-up ended
125 mg with 25 mg claim.
How would you respond?
Complaint
Higher strength than claim

33. A product has two strengths
25 mg & 125 mg.
Label mix-up ended
25 mg with 125 mg claim.
How would you respond?
Complaint
Lower strength than claim

34. You are certainly aware that your
API supplier is issued an import
alert notice from any country
because of fraudulent data and
integrity issues. You have
materials in your stock from that
supplier and a number of batches
manufactured from that affected
material are in market.
How would you respond?Surprise

35. Natural disaster at a particular
geographical location. Breakdown
of electricity occurred where your
drug was stored. Environment
experienced cool shocks of -20 ℃
for several days. Your product
was demonstrated stable at 2 to
8℃.
How would you respond?
Salvaged

36. Natural disaster at a particular
geographical location. Breakdown
of electricity occurred where your
drug was stored. Environment
experienced heat shocks of +40 ℃
for several days. Your product
was demonstrated stable at 15 to
25℃.
How would you respond?
Salvaged

37. You manufactured 3 million liter
syrup in 3 years of 3 year shelf life.
You found deterioration of API in
regular study at 6 months. You
investigated and took 6 months to
establish it. Once you established, 2
million liter was in market. You
stopped manufacturing and started
recall. Less than 2 liter was recalled
in next 6 months.
Please comment what went wrong?Efficiency

38. Your drug product in market was
claimed to be in child resistant
container. It was reported that some
children are able to open it. you
checked and found something is
wrong with your container that was
used in a particular year. However,
same is not verified from retention
samples.
What should be the recall class?
Claim

39. A particular batch of your product
is counterfeited. Public health is a
shared responsibility of government
and manufacturer.
What is your responsibility?
Counterfeit

40. Fast release was reported by the
Government laboratory for your
product or for your drug claimed to
be based on advance delivery
system.
How will you respond, if it is
patches?
How will you respond, if it is oral
tablet?
Release Profile

41. Product information
Reason of recall
What to do
Share any one case

42. Round One
(A)

43. A
B
D
E
C
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer

44. Round Two
(B)

45. B
C
E
A
D
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer

46. Round Three
(C)

47. C
D
A
B
E
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer

48. Round Four
(D)

49. D
E
B
C
A
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer

50. Round Five
(E)

51. E
A
C
D
B
Describe Scenario (all 3)
Record A completely
Write communication to Regulator
Write communication to Healthcare Staff
Write communication to Patient / Consumer

52. Thank You