1. Design, Trust & Control of Sterile Manufacturing (Opening Note)

Design, Trust & Control of Sterile Manufacturing

Obaid Ali & Roohi B. ObaidCivil Services Officers, Government of Pakistan

12th March 2016, Saturday, Karachi

08th

Technical Meeting / Forum

Sterile Manufacturing

Part II 1

Design, Trust & Control of Sterile Manufacturing

• Presentation, case studiesTutorial

• Real time experience & knowledge sharing among participantsDiscussion

• To clarify and address specific questionsQ & A

Way

to P

roce

ed

Design, Trust & Control of Sterile Manufacturing

Opening Questions & recap of Part I

Inherent Challenges

Observations & Comments

Design, Trust & Control of Sterile Manufacturing

Mr. Sultan Ghani Dr. Iftikhar A. Jafri Mr. Anis. A. Shah

Mr. Rizwan Ahmed Dr. Obaid Ali

Design, Trust & Control of Sterile Manufacturing

Opening Questions

Brain

Heart

Kidneys

Human body’s vital organs

Lungs

Liver

Blood

Opening Questions

Q1. Which dosage form approaches fast to vital organs?

Tablet Cream Injection

Tablet Cream Injection

Q1. Which dosage form approaches fast to vital organs?

Q2. In which manufacturing area particles and microorganisms require

highest control?

Tablet

CreamInjection

Q2. In which manufacturing area particles and microorganisms require

highest control?

Tablet

CreamInjection

Q3. Which defect is difficult to be caught?

Breakage

ContaminationDeformation

Q3. Which defect is difficult to be caught?

Breakage

ContaminationDeformation

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

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

Regulatory Intent

Drug product free of microbial,

chemical & physical contaminants

Please Note

Injectables are easy in formulation,

but difficult in manufacturing

Injectables are fast in response,

Sometimes irreversible

Please Note

Irreversibility may lead to death, permanent damage,

adverse drug reaction, prolonged hospitalization, serious to minor allergic

reaction, …….

Please Note

Particles and microbiological

contamination are a continuous challenge in

manufacturing

Continuous Headache

Design, Trust & Control of Sterile Manufacturing

Recap of Part I