STANDARD OPERATING PROCEDURE Title: RELEASE OF COATING MATERIAL WITH ADJUSTMENT REMARKS

1. Purpose

It is established to minimize the color variation problem in tablets.

2. Scope

Applicable to R&D , Q.A, Q.C and production department.

3. Responsibilities

1. Manager Quality Control
2. Manager R&D
3. Manager Quality Assurance
4. Manager Production

4. Procedure
1. Quality Control will intimate Quality Assurance before releasing any coating material when adjustment required.
2. Quality Assurance will inform Research & Development about this material.
3. Research & Development will decide the quantity of that material by conducting trial & will inform to R.M.S, Q.A & production department in written.
4. Solution of that product will be prepared in the presence of production, R&D and Quality Assurance
5. Coated tablet will then be matched with standard, if available, otherwise to previous last three batches.