Value as a Long-Term Partner – Escort a Multinational Enterprise for Compliance Projects

Fresenius Kabi

Fresenius Kabi is a global healthcare company that specializes in infusion, transfusion and clinical nutrition, which offers reliable medical assurance for critically and chronically ill patients with quality medicines, medical devices and services. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

Project Background

Since 2003, AUSTAR has been providing quality compliance validation services to four branches of Fresenius Kabi in China. Fresenius Kabi provides timely and reliable healthcare solutions to healthcare professionals and patients through first-class local R&D capabilities, strict quality assurance and efficient production & distribution network.

Solution

Fresenius Kabi SSPC:

AUSTAR has participated in several projects of Fresenius Kabi SSPC, including turnkey project of enteral nutrient solution laboratory instruments, laboratory computerized system validation (CSV) project, AIO pilot plant transformation & verification project, enteral nutrient solution verification project and FSMP project. As a turnkey service provider for overall validation in these projects, AUSTAR provided the following services under the guidance of Fresenius Kabi SSPC's expert team: compliance validation services for plant facilities and equipment, including review and preparation of verification documents, FAT/SAT witness, execution and support of verification tests, review and preparation of verification & test reports.

Beijing Fresenius Kabi Pharmaceutical Company Limited:

Since 2003, when it first provided HVAC validation of oral solid workshop and IOQ validation of clean room to Beijing Fresenius Kabi, AUSTAR has been delivering a number of successful projects to the expert team of the company over the years, including working together for the new cleanroom validation and automatic control system transformation and air conditioning validation service in clean room in 2011, and cooperating with the team of the company for equipment debugging, validation and verification for the relocation of a solid pharmaceutical production line in 2015.

Beijing Fresenius Kabi Pharmaceutical Company Limited R&D Center in Wuhan:

AUSTAR has contributed to the validation and verification of utility, clean utility system and process equipment for the R&D Center, including the review and preparation of verification documents and the implementation of verification tests, computerized system verification for process equipment, pre-certification simulation check and compliance consulting support.

Fresenius Kabi (Guangzhou) Co., Ltd.

AUSTAR has provided Fresenius Kabi (Guangzhou) with pure steam quality test, coverage test for cleaning verification of batching tanks and other validation& test services.

Benefits

AUSTAR delivered projects in strict compliance with the customers' requirements in internal quality and delivery schedule, which all complied with PRC GMP, US cGMP and EU GMP standards.