TECHNICAL DOCUMENT INDEX

S.No.

Table of Contents

Page No.

Part I:  Administrative Information ------------------------------------------------

1.

Name of the product -------------------------------------------------------------

2.

Pharmaceutical form and strength ----------------------------------------------

3

Route of administration ----------------------------------------------------------

4.

Pharmo-therapeutic classification ----------------------------------------------

5.

Pharmaco therapeutic classification (Anatomic-Therapeutic Classification system) ------------------------------------------------------------

6.

Presentation -----------------------------------------------------------------------

7.

Shelf life ---------------------------------------------------------------------------

8.

Storage condition -----------------------------------------------------------------

9.

Name and address of applicant -------------------------------------------------

10.

Name and address of the Manufacturer of the finished product -----------

Part II:   Summary of Product Characteristics -------------------------------------

Part III:  Quality---------------------------------------------------------------------------

1.

Description and composition per dosage unit  ----------------------------

2.

Manufacturer  -------------------------------------------------------------------

2.1.

Description of manufacturing process -----------------------------------------

2.2.

In-Process controls----------------------------------------------------------------

2.3

Retrospective Validation --------------------------------------------------------

2.4

Batch Manufacturing and Packing records -----------------------------------

3.

Control of API and excipients  -----------------------------------------------

3.1.

Analytical Procedures for API --------------------------------------------------

S.No.

Table of Contents

Page No.

3.2.

Analytical Procedures for Excipients ------------------------------------------

3.3.

Batch analysis of API and Excipients -----------------------------------------

4.

Control of drug Products ------------------------------------------------------

4.1.

Specifications and Analytical procedures -------------------------------------

4.2.

Batch Analysis --------------------------------------------------------------------

4.3.

Validation of Analytical  procedures ------------------------------------------

5.

Container Closer System ------------------------------------------------------

6.

Comparative dissolution studies----------------------------------------------

7.

Stability ---------------------------------------------------------------------------

Part IV:   Documentation on Clinical Data ------------------------------------------