AUSTAR Provided Compliance and Validation Consulting Services for a Large Listed Company's API Project

Introduction:

As global demand for healthcare increases and R&D of new drugs accelerates, the size of the API market continues to expand, with specialty and proprietary APIs becoming the new driving force for market growth. The API market has shown strong growth potential under the active guidance of policies. National and local governments have introduced a series of policies aimed at promoting the green and high-quality development of the API industry, strengthening technological innovation and industrial upgrading, and achieving a more prosperous and diversified development landscape.

Client Background:

The client is a large listed company whose main business covers a wide range of areas, including chemical pharmaceuticals, biological products, modern traditional Chinese medicine, health supplements, and medical devices. The client has established multiple pharmaceutical production bases around the world. Several of its drugs have been certified by WHO, FDA, and the EU, and are sold in global markets.

Scope of Services:

Validation Services for the New API Production Base: 

• Validation Master Plan and System Classification Assessment 

• Qualification of Clean HVAC Systems and Clean Utilities 

• API Process Equipment Qualification 

• Laboratory Instruments and Equipment Qualification 

• Computerized System Validation

AUSTAR Contributions and Client Benefits:

• The project complies with FDA cGMP standards.

• Established a validation system that meets the latest regulatory requirements.

• Assisted in efficiently accelerating the client's project progress. 

• Collaborated with the client's team to enhance technical capabilities in validation activities.