This document discusses the design, trust, and control of sterile manufacturing. It begins with opening questions about which dosage form approaches vital organs fastest (injection), which manufacturing area requires the highest control of particles and microorganisms (injection manufacturing), and which defect is most difficult to detect (contamination). The document then provides an overview of inherent challenges in sterile manufacturing and notes that injectables are easy to formulate but difficult to manufacture due to the need for strict control of contamination. It emphasizes that contamination in injectables can lead to serious health consequences since injections take effect rapidly and potential issues may not be reversible. The document stresses that particles and microbial contamination present a continuous challenge in sterile manufacturing.

1. Design, Trust & Control of
Sterile Manufacturing
Obaid Ali & Roohi B. Obaid
Civil Services Officers, Government of Pakistan
12th March 2016, Saturday, Karachi
08th
Technical Meeting /
Forum
Sterile
Manufacturing
Part II
1

2. Design, Trust & Control of Sterile Manufacturing
• Presentation, case studiesTutorial
• Real time experience & knowledge
sharing among participantsDiscussion
• To clarify and address specific
questionsQ & A
WaytoProceed

3. Design, Trust & Control of Sterile Manufacturing
Opening Questions & recap of Part I
Inherent Challenges
Observations & Comments

4. Design, Trust & Control of Sterile Manufacturing
Mr. Sultan Ghani Dr. Iftikhar A. Jafri Mr. Anis. A. Shah
Mr. Rizwan Ahmed Dr. Obaid Ali

5. Design, Trust & Control of Sterile Manufacturing
Opening Questions

6. Brain
Heart
Kidneys
Human body’s vital organs
Lungs
Liver
Blood

8. Opening Questions

9. Q1.
Which dosage form approaches fast to vital organs?
Tablet Cream Injection

10. Tablet Cream Injection
Q1.
Which dosage form approaches fast to vital organs?

11. Q2.
In which manufacturing area particles and microorganisms require
highest control?
Tablet
CreamInjection

12. Q2.
In which manufacturing area particles and microorganisms require
highest control?
Tablet
CreamInjection

13. Q3.
Which defect is difficult to be caught?
Breakage
ContaminationDeformation

14. Q3.
Which defect is difficult to be caught?
Breakage
ContaminationDeformation

15. DISCLAIMER
Not the view of DRAP
Current judgment of
speaker
No obligation on DRAP
Regulatory experience
It has nothing to do
with any specific
commercial product
It is just a knowledge
sharing exercise
nothing more than
that

16. Reference: “Particulate Matter in Injectable Drug Products”
Stephen E. Langille, PDA J Pharm Sci and Tech 2013, 67 186-200
Sterile Drug Products produced by Aseptic Processing-
Current Good Manufacturing Practice
Guidance for Industry, US-FDA, September 2004

17. Regulatory Intent
Drug product free of
microbial,
chemical & physical
contaminants

18. Please Note
Injectables are easy in
formulation,
but difficult in
manufacturing

19. Injectables are fast in
response,
Sometimes irreversible
Please Note

20. Irreversibility may lead to
death, permanent damage,
adverse drug reaction,
prolonged hospitalization,
serious to minor allergic
reaction, …….
Please Note

21. Particles and
microbiological
contamination are a
continuous challenge in
manufacturing
Continuous Headache

22. Design, Trust & Control of Sterile Manufacturing
Recap of Part I