Good Pharmaceutical Manufacturing Practice

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Summary

This is an essential guidebook for those who wish to expand their pharmaceutical business in any international capacity.

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Introduction - Status and Applicability of U.S. Regulations/E.U. Guidelines
General Quality Issues
Personnel, Organization and Training
Premises/Buildings and Facilities
Contamination and Contamination Control
Equipment
Materials Control
Production and Process Controls
Packaging and Labeling Control
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged products
Sterile Products Manufacture
Other GMP Issues
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