1. design, trust & control of sterile manufacturing (opening note)
TRANSCRIPT
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