Process Validation for Sterile Manufacturing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Process Validation for Sterile Manufacturing


 


William (JR) Humbert
Validation Manager,
Cook Pharmica


Add this Podcast feed to your media player



This podcast discusses the 2011 FDA Guidance for the Industry, Process Validation: General Principles and Practices, and the impact the guidance has for biotechnology and pharmaceutical companies performing sterile manufacturing process validation.  The three stages of process validation in the guidance and their implications for sterile manufacturing are discussed.  The podcast concludes with a discussion regarding PAT tools that can assure a sterile manufacturer that sterile processes will remain in a validated state over the lifecycle of the sterile product.
 


ONLINE RESOURCES



ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?

Click here