FPREPARED BY : DATE : CHECKED BY : DATE: APPROVED BY DATE:

:
Senior Q.C. Officer Asst. Q.C. Sr. Q.C.
Manager Manager
 CONTENTS

1. PURPOSE
2. SCOPE
3. DISCRIPTION
4. INTRODUCTION
5. EXPERIMENTAL
6. METHOD DEVELOPMENT BY HPLC
7. INSTRUMENT PRECISION
8. OUTLINE FOR THE VALIDATION PROTOCOL
9. STATISTICAL DATA & ACCEPTANCE CRITERIA
10. DISCUSSION
1. Purpose:
To describe the procedure for validation or verification of analytical test methods and build confidence in measurements taken on
samples of incoming materials and products.

2. Scope
This SOP is applicable for the validation of HPLC analytical method for Amilip 5mg tablet.

3. Description
Product Name: Amilip 5mg tablet