Global Regulatory Approach to API Manufacturing

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology, APIs, Excipients, and Manufacturing, October 2021
Pages: 18-21

Navigating a complex global regulatory landscape involves upfront research into the expectations of the different regulatory bodies, thorough documentation of every step of the API manufacturing process, and good communication.

AdobeStock_293317053_magele-picture

AdobeStock_293317053_magele-picture

Prior to the commercialization phase for API manufacturing, there is a lot to juggle as well as a tricky global regulatory landscape to navigate. API manufacturers must meet the standards for the country where the drug will be distributed, and every country has its own regulations as well as its own interpretation of those regulations.

October 2021 API eBook

Read this article in Pharmaceutical Technology’s October 2021 APIs, Excipients, and Manufacturing eBook.

About the author

Meg Rivers is a senior editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Article Details

Pharmaceutical Technology
eBook: October 2021
Pages: 18-21

Citation

When referring to this article, please cite it as M. Rivers, “Global Regulatory Approach to API Manufacturing," Pharmaceutical Technology eBook (October 2021).

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Knowledge Management
Pharmaceutical Knowledge Management: Experiences in Drug Development and Manufacturing
Shining a Light on Photochemistry in Flow
Shining a Light on Photochemistry in Flow
Predicting Tablet Potency in Continuous Manufacturing
Predicting Tablet Potency in Continuous Manufacturing
Powder Testing
Building Robust Specifications Using Powder Testing
Global Regulatory Approach to API Manufacturing
Global Regulatory Approach to API Manufacturing
Seeking Economies of Scale for Biocatalysis
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API Development and Manufacturing: Advantages of Working with Small Molecules
API Development and Manufacturing: Advantages of Working with Small Molecules
Rethinking, Recalibrating, and Retooling
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