For biopharmaceutical and biomedical laboratories, GMP standards must be met when designing laboratories. This issue of industry information will introduce the new version of the country's GMP standards, including introduction, concept, and features. Please pay more attention to it.

I. Introduction to the new national GMP standard

As mentioned above, the design of biopharmaceutical and biomedical laboratories must meet GMP standards. Since the old version of the GMP standard (98 version) is no longer suitable for society, the country has implemented the new version of the GMP standard-"Good Manufacturing Practice for Drugs (Revised in 2010)" from March 1, 2011.

This new version of the GMP standard is based on the EU GMP standard, combined with domestic actual conditions and needs, and is formulated with the WHO 2003 version as the bottom line. Compared with the 98th edition, the new GMP standard is undoubtedly more stringent in terms of management and technical requirements. This is particularly evident in the production of sterile preparations and APIs.II. The concept of the new national GMP standard

According to the new national GMP standard, two concepts should be introduced in laboratory design: quality risk management and quality management system.

Idea 1: Quality risk management. This concept focuses on the company's quality management system, requiring companies to establish their own quality management system and introduce risk management in actual operations. The implementation of GMP must be based on science and risk.

Idea 2: Quality management system. This concept focuses on the specific requirements of the enterprise quality management system, which requires that this system must be comprehensive, systematic and rigorous. In order to ensure the effective operation of this system, a reasonable management system and sufficient human resources must be formulated.

III. Features of the new national GMP standard

According to the new national GMP standard, two characteristics should be strengthened in laboratory design, namely: software requirements and hardware requirements.

Feature 1: Strengthen software requirements. Reflected in three points, the first point is to strengthen the construction of the drug production quality management system; the second point is to strengthen the quality requirements of the practitioners; the third point is to refine the document management regulations such as operating procedures and production records.

Feature 2: Strengthen hardware requirements. It is also reflected in 3 points. The first point is to adjust the cleanliness requirements of sterile preparations and increase the requirements for equipment and facilities; the second point is to make specific details on equipment design and installation, maintenance and repair, use and cleaning Regulations: The third point is to propose design and layout requirements for the facilities in the laboratory according to the production area, storage area, quality control area, and auxiliary area.

This is the end of the article about the new version of the GMP standard for laboratory design.