Pharmaceutical Manufacturing Dashboard 2017 Review

1. Your claim is your promise
Disease and drug has no religion
Hold your promise to be trustable
and be accountable
Roohi Obaid
Deputy Director, DRAP, Karachi
Pakistan

3. Visible participation
is required to move
forward
We will capture
every movement

4. Moving Hand: requires
clarification
Static Hand: move forward

5. Taking regulatory risk is dangerous and
may no longer compare with the price of
being caught
Take Home Message
Set the Tone on Full Compliance Mode

6. Planned deviations are vulnerable to
regulatory observation & consequences.
It may not always be an excuse for not
following the procedure in place
Take Home Message
Set the Tone on Full Compliance Mode

7. Retesting into compliance was never
encouraged, now it is intolerable and have
regulatory consequences
Take Home Message
Set the Tone on Full Compliance Mode

8. Top management even offsite is
responsible & may face fines, prison and
other penalties even for happening
involuntary injuries
Take Home Message
Set the Tone on Full Compliance Mode

9. Review critically every decision & actual
practice to record every data value …..
Save yourself from being a victim of testing
into compliance with sincere intentions
Take Home Message
Set the Tone on Full Compliance Mode

10. Layout in terms of product, personnel and
process flow if not in spirit of GMP, have a
definite potential to create uncertainty in
manufacturing of quality drugs
Take Home Message
Set the Tone on Full Compliance Mode

11. User Required Specifications (URS) represent
the critical design parameters and it is
generated prior to Design Qualification (DQ)
Take Home Message
Set the Tone on Full Compliance Mode

12. System lifecycle demands a good
understanding on characterizing the system
with respect to its potential effect on Quality
(Product Performance & Patient Safety)
Take Home Message
Set the Tone on Full Compliance Mode

13. Over 1.5 million adverse event and medication
error reports are received by US-FDA alone
Gulf in proportionality is visible and no further
comments are required
Take Home Message
Set the Tone on Full Compliance Mode

14. Don’t declare the original OOS as an “outlier” and use
the retest without establishing the root cause
Such statistical treatments can’t always identify the
cause of an extreme observation
Take Home Message
Set the Tone on Full Compliance Mode

15. Characterize more extensively the
uniformity of the batch produced in hours
or in few shifts
Take Home Message
Set the Tone on Full Compliance Mode

16. Don’t miss the opportunity to investigate possible
manufacturing cause of inconsistency in content
uniformity if initial OOS is not laboratory error
It is not a choice, it is an obligation
Take Home Message
Set the Tone on Full Compliance Mode

17. Testing of drugs is absolutely nothing if
they are not manufactured in a compliant
manufacturing environment
Take Home Message
Set the Tone on Full Compliance Mode

18. Manufacturing in a compliant environment and
its testing does not fulfill the intent without
oversight programs for quality surveillance
Take Home Message
Set the Tone on Full Compliance Mode

19. Operations Contractors are indeed extension of
manufacturers … GMP compliance is not an
option, but obligation
Take Home Message
Set the Tone on Full Compliance Mode

20. Change or Repack in new container
closure is required to be assessed for its
equivalency with the old one
Stability data is an obligation to support expiry date
Take Home Message
Set the Tone on Full Compliance Mode

21. Be distinctive
Don’t miss to capture knowledge if you
find that your drug product is unstable in
the new container
Take Home Message
Set the Tone on Full Compliance Mode

22. Every deficiency has an impact on patient
health, your own promise and
product performance
Don’t let it go, assess accurately and sincerely, be aware
Take Home Message
Set the Tone on Full Compliance Mode

23. Always investigate potential manufacturing root cause
and don’t let it go, if reason of sterility failure is not
associated with laboratory
EM data of years not weeks should be subject to
evaluation
Take Home Message
Set the Tone on Full Compliance Mode

24. Regular assessment of microbiological contamination
risk of current process, equipment and facility is
backbone of quality of product and safety of patient
Take Home Message
Set the Tone on Full Compliance Mode