AUSTAR Provided Validation Consulting Services Complying with Chinese & EU GMP for a Leading Manufacturer of Food for Special Medical Purpose

Introduction:

Food for special medical purpose (hereinafter referred to as “FSMP”) is a formula food specially processed to meet special needs of people with restricted feeding, digestion and absorption disorders, metabolic disorders or specific diseases for nutrients or diets. It has been proven by numerous studies that FSMP can improve survival rates, shorten hospital stays, and reduce related costs, the number of readmissions and complications for patients. With the coming of an aging society, the pressure of medical expenses and medical insurance is increasing, and people has growing concern on nutritional knowledge and nutrient condition. More and more nutritionists, doctors, clinical nutritionists, and patients are paying attention to the use of FSMP in clinical practice. The Chinese FSMP market is embracing new development opportunities.

Customer Background:

As the first professional clinical nutrition company in China, the customer, dedicated in manufacturing parenteral nutrition preparations, enteral nutrition preparations, food for special medical purpose and medical devices, is the only company in China that can provide integrated nutritional support for patients. According to the development needs of the China pharmaceutical market, the customer continues to introduce new products and clinical nutrition concepts, and improve production capacity and production processes with the most advanced production equipment and perfect GMP management to meet the production needs of more and more high-quality products.

Scope of Services:

• NMPA/EMA GMP&HACCP standards.

• Validation master plan (VMP).

• Utility system commissioning and qualification services.

• Process equipment commissioning and qualification services.

AUSTAR Contributions and Customer Benefits:

• Provided the customer with high-quality protocols, reports and execution, ensured the project was delivered successfully, and met Chinese and EU regulatory requirements.

• Improved the quality management system of the customer, and established good corporate culture of learning organization.

• Passed Chinese and EU GMP inspections, and two products of FSMP have been approved for marketing in November 2023, which is a“breakthrough” in the field of FSMP certification.