Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas

Miele,William;Huxsoll,Jean;Seawell,Betty;

Publication

Article

September 1, 2003

BioPharm International

BioPharm International-09-01-2003

Volume16

Issue 9

Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas

Author(s):

William Miele,Jean Huxsoll

The complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.

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Articles in this issue

Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas

A Case Study for the Inactivation of TSE Agents: Using an Alkaline Treatment in the Manufacturing Process of a Cell Culture Media Supplement

Inside Washington: Reimport Battle Complicates Anticounterfeiting Campaign

Integrating CMC Document Preparation into the Development Process for Vaccine INDs

Large-Scale Manufacturing of Plasmid DNA for Gene Therapy and DNA Vaccination -- Part 2: Toward an RNase-Free Downstream Process ? A Review

Sterile Fill Facilities: Problems and Resolutions

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