Pharmaceutical process devolopment

Juhi Sharma's picture
Submitted by Juhi Sharma on Fri, 10/09/2009 - 08:16
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Pharmaceutical Product Development:

Objectives:

1.Provide a continuous link from early phase characterization to final manufacturing process- Process Development is the link through all these phases

2.Define process based on unit operations approach-Unit Operations define the building blocks of the process.

3.Provide a road map for tracking success of scale up activities and technology transfer.

4.Enable effective process monitoring and improvements-This road map shows meaningful markers for success

Pharmaceutical Process/Product Development: Initial Design

•Identify parts of process which are most susceptible to failure upon scale-up

•Conceptual “scale down” of the final manufacturing process into the pilot plant and the lab

Pharmaceutical Product Development: Process Control

•Define process through measurable, quantitative endpoints – PAT?

•Evaluate how process can respond to variations in process equipment performance and/or raw materials characteristics

•Provide continuous fingerprint of process performance – NOT regulatory specifications

Pharmaceutical Product Development: Continuous Improvement

-“Hooks” for future process improvement.

-Plan into development program collection of “fingerprint” data for future comparisons

–Design validation protocols to collect similar “fingerprints”

–Use in manufacturing to continuously monitor process operation and status

Ref.Drugs & P’ceutical sciences, Volume 112, Anthony J. Hickey)

Vedika Gulati's picture

nice information , elaborate

Submitted by Vedika Gulati on Wed, 10/14/2009 - 11:34.
5

nice information , elaborate it more precisely...
keep sending

Vedika Gulati Team Infinity "∞" http://www.pharmainfo.net/blog/team-infinity

Supriya vavilapalli's picture

dear juhi, Does statastics

Submitted by Supriya vavilapalli on Sun, 10/11/2009 - 11:40.
3

dear juhi,
Does statastics apart of process developement?

Supriya vavilapalli

THE COGNITIVE MOLECULES

http://www.pharmainfo.net/supriya-vavilapalli

Sirisha Pingali's picture

dear juhi.. Thats very nice

Submitted by Sirisha Pingali on Sat, 10/10/2009 - 01:35.
3

dear juhi..
Thats very nice information you provided us. In this context, what does "fingerprint" mean??

Sirisha Pingali http://www.pharmainfo.net/sirisha/biography

Dear Ms. Juhi, Can you put

Submitted by Nikhil on Fri, 10/09/2009 - 11:25.
3

Dear Ms. Juhi,

Can you put some light on following statement:

"Hooks” for future process improvement."

Regards

Zarrin Faria's picture

Dear... Nice

Submitted by Zarrin Faria on Fri, 10/09/2009 - 09:47.
5

Dear...
Nice information...what are the measures that could be taken to decrease errors in the product development process at the various steps??
Regards,
Faria Zarrin
Team: BLOGBUSTERS

My Page :
http://www.pharmainfo.net/zarrinfaria/biography

My Team:
http://www.pharmainfo.net/blog/blogbusters