Parenteral Quality Control

Parenteral Quality Control

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Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.where P(Mn)i is the rejection probability associated with the nth manual inspection in a probability group, P(MI)i is the ... 3.6, where Accept zone, p .3 Gray zone, .3 p .7 Reject zone, p .7 Figure 3.6 also shows three terms: RZN, RZR (M1), andanbsp;...

Title:Parenteral Quality Control
Author: Michael K. Akers, Dan Larrimore, Dana Guazzo
Publisher:CRC Press - 2002-11-20

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