Connect to the Future from the Past - Part 4/4

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

2. Enable development & evaluation of important &
improved manufacturing methods

3. Investigate
Evaluate
Examine
Promote

4. Investigate the effect of continuous
manufacturing on product
1
Examine technologies to determine how
they impact product failure rates
2

5. Evaluate the role of excipients & complex
dosage forms on product
3
Promote state of art manufacturing
strategies, PAT, QbD & consistent quality
4

6. Develop new analytical methods

7. Investigate
Perform
Evaluate
Develop

8. Investigate feasibility & value of using
emerging & improved analytical
technologies for evaluating product
quality of pharmaceutical agents, and
evaluate whether these technologies
should replace existing methods
For e.g. NMR, MS, NIR, Raman Spectroscopy
1

9. Evaluate applicability of various analytical
technologies for determination of the
similarity of biosimilar to their reference
product
2

10. Perform statistical research to support
development & evaluation of new assay &
tests needed to assure analytical methods
give consistent reproducible results
3

11. Develop improved method & tools to
detect & measure the physical structure,
chemical properties & safety of
engineered nanomaterials & complex
dosage forms.
For e.g. transdermal patches, inhalation delivery
systems & targeted drug delivery systems
4

12. Reduce risk of microbial contamination of
product

13. Develop
method
Evaluate
the impact
Evaluate
method
Develop
reference

14. Develop sensitive, rapid, high-throughput
methods to detect, identify, & enumerate
microbial contamination and validate their
utility in assessing product sterility
1

15. Develop & evaluate methods for microbial
inactivation/removal from pharmaceutical
products that are not amenable to
conventional method of sterilization
2

16. Evaluate the impact of specific
manufacturing process on microbial
contamination
3

17. Develop reference material for use by
industry & academia to evaluate and
validate novel methods for detecting
microbial contamination
4

18. Regulatory
Sciences
Research
Novel
manufacturing
methods
Analytical
method
During &
after
manufacturing
Lowering the
cost of
manufacturing
Improving the
ability of
regulatory
Safety
Quality
Efficacy

19. Thanks