SOLUTION

Information Integration

Overall Construction of Hospital Preparation Room

Overall Construction of Integration Platform of Production and Education in Colleges and Universities

Certification Consulting

GPP Certification Consulting Services

As the country attaches importance to the development of the pharmaceutical industry and the healthy living needs of the whole people, the management and policy requirements for hospital preparations are also constantly improving. In 2000, the country implemented the "Good Preparation Preparation Quality Management Regulations for Medical Institutions" (Practice abbreviation GPP), which was formulated according to the provisions of the the People's Republic of China Drug Administration Law and the basic principles of the Drug Production Quality Control Regulations, the main aspects of the preparation of medical institutions, such as the preparation environment and equipment requirements, health management, standard operating procedures, quality inspection and other aspects of the provisions.

This specification is the basic guideline for the preparation and quality management of medical preparations, which is applicable to the whole process of preparation, and is mainly formulated for all factors that may affect the quality of preparations. Fuzhou Famo Youke Machinery Technology Co., Ltd. is committed to the overall solution of the preparation room, including GPP certification services for the hospital preparation room.

The following are the main contents of the service:

1. provide all kinds of documents in accordance with the latest regulatory requirements;

2. guide the inspection of production process of equipment, instruments, workshops and products;

3. guide and participate in the training of the personnel in the preparation room;

Collate and summarize all kinds of 4. files (including equipment and instrument files, supplier files, training files, self-inspection files, etc.);

In addition to the following value-added services to choose from:

1. Guide Party A to select qualified material suppliers and guide the specific production process;

2. Guide Party A to set up the organization of the preparation center and allocate all kinds of personnel;

3. Responsible for guiding Party A to formulate annual training plan, providing complete training materials (including training plan, training materials, training questions, training lecturers, etc.), and responsible for the training of pharmaceutical laws and regulations and major management projects.

4, responsible for the preparation of a complete set of GMP-compliant documents and technical information;

5. Responsible for guiding Party A to complete all kinds of verification work, including equipment verification, inspection method verification, cleaning verification, process verification, etc;

6, responsible for guiding Party A to complete all kinds of records to fill in the work.

7. Be responsible for guiding Party A to complete the sorting and improvement of various files (provide a full set of templates).

8. Be responsible for guiding Party A to prepare the application materials of "Medical Institution Preparation License" according to the new laws and regulations, until the "Medical Institution Preparation License" is obtained.

9. Before the formal on-site inspection, organize 2-3 experts to conduct a simulated inspection of Party A's preparation and put forward rectification opinions.

10. After the on-site inspection, Party B shall guide Party A to prepare the rectification materials of defective items.

Related programmes

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Construction of Pharmaceutical Engineering Training Center