Parenteral Quality Control

Parenteral Quality Control

4.11 - 1251 ratings - Source



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
ISBN-13:

You must register with us as either a Registered User before you can Download this Book. You'll be greeted by a simple sign-up page.

Once you have finished the sign-up process, you will be redirected to your download Book page.

How it works:
  • 1. Register a free 1 month Trial Account.
  • 2. Download as many books as you like (Personal use)
  • 3. Cancel the membership at any time if not satisfied.


Click button below to register and download Ebook
Privacy Policy | Contact | DMCA