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The Role of ICH and How to Meet Quality Guidelines in API Manufacturing
Tags:
API Manufacturing
|
Blog
|
Compliance
|
ICH
Posted December 1, 2020
10 Strategies for Lowering Elemental Impurities in APIs
Tags:
API Manufacturing
|
Blog
|
ICH
|
Impurities
Posted September 21, 2020
Setting Comprehensive Specifications in API Manufacturing
Tags:
API Manufacturing
|
Blog
|
CDMO
|
ICH
|
Standard Operating Procedures
Posted January 16, 2018
API Quality Risk Management
Tags:
Blog
|
CDMO
|
Cost
|
ICH
|
Quality Systems
Posted December 7, 2017
Best practices in following ICH guidelines for APIs
Tags:
API Manufacturing
|
Blog
|
EMA
|
Equipment
|
FDA
|
How to select a CMO
|
ICH
Posted July 6, 2017
The Dirty Little Secret About Process Optimization in API Manufacturing
Tags:
API Manufacturing
|
Blog
|
ICH
|
Optimization
|
Pharmaceutical Manufacturing
Posted June 21, 2017
Despite all the Rhetoric, Time-Consuming FDA Guidelines Make More Work for CMOs but Safe Products for Consumers
Tags:
Blog
|
FDA
|
GDUFA
|
How to select a CMO
|
ICH
|
Pharmaceutical Manufacturing
|
Safety
Posted June 15, 2017
Why the FDA and EMA want you to implement QbD
Tags:
Blog
|
EMA
|
FDA
|
ICH
|
Research and Development
|
Scale-up
|
Standard Operating Procedures
Posted June 2, 2017
Outsourcing Your API Manufacturing to Asia?
Tags:
Articles
|
China
|
ICH
|
Pharmaceutical Outsourcing
Posted April 5, 2017
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