Chromatography Forum

Posted: **Sat Jan 26, 2013 9:34 pm**

my recent job is writing a validation protocol for HPLC method development i read many books and guidelines as ICH and FDA and now i need a example for validation protocol as guide for me please help.

Posted: **Mon Jan 28, 2013 2:41 am**

Get a copy of Validating Chromatographic Methods: A Practical Guide by
David M. Bliesner. It's got the templates you need.

Here's a link to it on Amazon:
http://tinyurl.com/cxmr6zy

Posted: **Mon Feb 04, 2013 9:06 pm**

my recent job is writing a validation protocol for HPLC method development i read many books and guidelines as ICH and FDA and now i need a example for validation protocol as guide for me please help.

I hope my template could help:
Approvals
1. Purpose
2. Scope
3. Responsibilities
4. Materials
5. Procedure: Experimental and Report what
(Speci/.......robustness: all the parameters you know)
6. Acceptance Criteria (for each parameters above)

Chromatography Forum

validation protocol

validation protocol

Re: validation protocol

Re: validation protocol