I

Establish an oral solid dosage form manufacturing facility with acceptable CGMP compliance

A) Conduct a system-based auditing

1) Quality System

2) Materials System

3) Facilities and Equipment System

4) Production System

5) Packaging and Labeling System

6) Laboratory Control System

B) Provide an auditing report to identify deficiencies and to recommend corrective actions.

C) Provide necessary CGMP trainings based on the deficiencies identified.

II

A) Conducting suitability studies on

· API

· Key excipients

· Formulation

· Product specification

· Product package

· Product stability

B) Development of manufacturing process

C) Manufacture of one pilot batch for stability and BE studies

A) Provide CGMP consulting related to pre- formulation studies

· Pre-formulation report to provide data to support the product formulation and process design

B) Provide CGMP consulting on process design and development, which include:

· Product characterization and qualification studies

· Process design and process optimization

· Critical parameters and in-process controls

· Analytical method development

· Product development report.

III

Preparation and conducting formal process validation

(three conforming batches at commercial scale)

A) Provide consult service on formal process validation (three conforming batches) to establish process reproducibility and consistency

The following process documentations should be established:

· Formulation development report

· Process feasibility report

· Product development report

Validation Master Plan (Protocol and final report)

a) DQ/IQ/OQ/PQ

b) Cleaning validation

c) Analytical methods validation

d) Formal process validation

e) Out of specifications

 f) Change controls

g) Product stability report

B) The test used to demonstrate process reproducibility and consistency among validation (or conforming) batches should be:

· Particle or granule size distribution

· Bulk density

· Moisture content

· Hardness

· Thickness

· Friability

· Weight uniformity

· Potent uniformity

· Disintegration/dissolution profile

IV

Bioequivalence study (BE) conducted through CRO

Monitoring BE study from CGMP perspective

V

Provide related CMC information for preparation ANDA application

ANDA application preparation

· Drug substance section (DMF)

· Bioequivalence study section

· Drug product section

· Others