validation protocol

[mmm83]

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.

[tom jupille]

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

[zheyin]

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)