Quality Journey - Part 3/4

1. Quality Journey
(Part 3/4)
Training Session by
OR Centre for Quality Sciences
Obaid Ali & Roohi B. Obaid
Good Manufacturing Practices (GMP) of the 21st Century
04 April 2021, Hotel Marriott Karachi

2. Thanks to
Dr. Ajaz S. Hussain
Whose notes are always worthy and our
source of thinking & knowledge but expression is our
own independent understanding
Disclaimer

3. System is not Suitable
and/or Capable to cater the
emerging challenges
Transformation is the
ultimate choice
Complexity is increasing
and/or Uncertainty is
increasing
Reliable
Validity
&
Predictability
are critical

4. • Availability
• Affordability
• Assurance
GMP
21st Century Mandate
Pharmaceutical Drugs
Continuous Manufacturing, Data Sciences, Machine Learning,
Real time Release
OR Centre for Quality Sciences towards Knowledge Economy for Tomorrow

5. Material Attributes & Drugs
Higher variability gives higher opportunity to gain knowledge
and real time experience expands wisdom
Alignment and clarity in communication is critical

6. Wrong Perception
There is no problem
We don’t have any
complain
Our drug is passed upon
testing
Poor Consciousness
We use our medicine
ourselves
Our drug never failed by
Government
Smell threat
This is nothing but
immaturity & approach may
put patient lives at risk

7. Quality System Maturity

8. Analytical method and the
state of control is key to
determine process control
Traditional practices are no
longer science based & to
convert to science based is
Maturity

9. of product
From
Uni-variate thinking to
Multivariate
Quality Risk Management
Simply compendial tests
does not
tell that batch is ok

10. Chaos is a system that is
unpredictable beyond
average …. inability to
understand extreme
sensitivity
Uncertainty &
Expectation Management

11. of product
What habits and practices
need to be changed?
GMP ... Q10 … Maturity

12. Same Therapeutic Outcome
Assurances in Real World
depend upon
Quality of Development &
Effectiveness of QMS
Challenges .. Challenges .. Challenges

13. Cause & Effect relationships
are self evident
Best practices work
Cause & Effect relationships are
multifactorial,
need expertise to understand
Good practices work
Cause & Effect relationships
are not known
Research & development
are required
Cause & Effect relationships
are not known
Extreme sensitivity to
initial conditions
Cause &
Effect
Relationship

14. Education, Training & Experience
Practical contact with things in
the real world
How do you know
what you know

15. Towards Systemic Transformation
We need to free ourselves from
average thinking

16. CAPA are not
Continual Improvement
You can only improve a process
when you are in a state of control
You can’t improve when it is in
need of Corrective & Preventive
Actions

17. Time of traditional testing is over … Compliance of
specifications is not sufficient … Let’s move towards
higher level … Create space of thinking to design
quality … Increase ability to predict … Maintain
journey in upward direction … Prevent before anything
goes wrong

18. Is one time process validation on 3 batches
sufficient?
Does one BA/BE study gives assurance of product
quality over the lifecycle?

19. Is one time process validation on 3 batches
sufficient?
Does one BA/BE study gives assurance of product
quality over the lifecycle?

20. Is one time process validation on 3 batches
sufficient?
Does one BA/BE study gives assurance of product
quality over the lifecycle?
No

21. Validation
Number of Batches
3

22. Validation
Sound rationale is expected for process
validation
Minimum number of conformance
batches necessary to validate is no
longer specified

23. Validation
Successful completion of initial
conformance batches would normally
be expected before commencement of
commercial distribution with few
exceptions.
Exceptions include short supply
situations, orphan drugs

24. Validation
Large sample size & testing of
additional attributes are required for
exceptions

25. • Control variations
• Continuous monitoring
• Knowledge Management
• Professional development

26. Pharmaceutical manufacturing is not like simple, slow
and one way traffic ... It is a busy junction with multiple
cross-overs … rarely uni-variate and often multivariate
in the journey of manufacturing a batch
Every time you have to keep journey safe, secure, and
trustable for certainties

27. Thanks