Case Study: GMP Design Consulting for Plasma Project

Mainly taking healthy human plasma as raw materials, blood products, also known as plasma derivatives, are biologically active preparations produced by biological processes or separation and purification techniques, including albumin, immunoglobulins, and various coagulation factors. The blood products, compared with other pharmaceuticals, play an irreplaceable role in medical first aid and the prevention and treatment of certain diseases.

In 2020, the global market size of plasma derivatives was USD 36.47 billion, and it is expected to reach USD 89.77 billion, with a compound annual growth rate of 9.4% from 2021 to 2030.

Based on a profound understanding of FDA GMP and in conjunction with the owner's existing production and management systems, we conduct a thorough analysis and audit of the workflow. We then strategically plan various personnel flow paths to ensure compliance and efficiency.

According to CFR Title 21:

§ 211.28 Personnel responsibilities.
(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.

§ 211.42 Design and construction features.
(b) The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.

§ 606.20 Personnel.
(c) Persons whose presence can adversely affect the safety and purity of the products shall be excluded from areas where the collection, processing, compatibility testing, storage, or distribution of blood or blood components is conducted.

Project Information
The client is a blood product pharmaceutical enterprise in China, whose products cover three major categories: albumin, immunoglobulins, and coagulation factors. It plans to build a new blood product production base abroad. The project is required to comply with both the NMPA and the FDA. The project occupies an area exceeding 100,000 square meters, with an annual production capacity exceeding 1,000 tons.

Service Scope: Engineering Design Review

• Site master plan, production building, quality control building, warehouse, animal house.

• Project execution plan and plant URS.

• Floor layout, equipment layout, classification layout, flow analysis.

• Process description and production scheduling, URS for process systems and equipment.

• Washing and waste disposal strategies.

• PFD, P&ID, and clean utilities.

• AHU zoning, room pressure design, air conditioning design strategy.

• Automation

AUSTAR Contribution and Client Benefits

• Higher expectations for enhancing the standards for facility design and execution in the new project, since the domestic production facility has already met the requirements of the NMPA.

• Comply with the FDA and refer to the EU and WHO GMP.

• Design concepts of compliance, flexibility, and scalability.

• Reasonable planning and design of personnel flow and material flow.

• Comprehensive planning to simultaneously meet the production needs of Phase One and reserve space for the expansion in Phase Two.