01

Organization and personnel management

Organization and personnel management

The company is equipped with management personnel at all levels with certain professional knowledge, production experience and organizational ability and a certain proportion of technicians suitable for production management and quality management, workshop production and operation personnel all have an education background of high school and above, have received professional training and GMP knowledge training, and passed the examination and take the jobs with certificates.

02

Buildings and facilities management

Buildings and facilities management

The company’s buildings and facility meet the requirements, all have been validated, the areas are clear differentiated, the production environment is clean and tidy, there are no pollution sources around the plant, water quality and noise conform to the sanitary requirements for production, buildings are reasonably laid out according to the technological process and the required air cleanliness class, the personnel flow and the material flow are separated, the operation sites are spacious, various function rooms are set reasonably, and area easy to use during operation and can avoid contamination and cross contamination.

03

Equipment management

Equipment management

The production equipment and the supporting utilities are reasonably arranged according to the process requirements. The materials selected all are materials that do not have physical adsorption and chemical reactions with the drugs produced, with their surfaces smooth and easy to disassemble and clean. The scope of application and precision of instruments, meters, measuring tools and weighing instruments, etc. used in production and inspection all meet the requirements of production and quality inspection. They are calibrated periodically and have obvious qualified status signs, which have greatly improved the production efficiency during operation.

04

Materials and products management

Materials and products management

The company is equipped with a complete document system and operating procedures, which can be correctly implemented and recorded, can ensure the correct reception, storage, distribution, use and delivery, and prevent contamination, cross contamination, confusion and error; the sources of raw and auxiliary materials and packaging materials used are stable, quality assessment have been carried out for the determination and change of suppliers, and the transportation of materials and products can ensure the quality of drugs. each receipt of materials is recorded, with the content covering the 8 requirements specified in Article 106 of the GMP.

05

Document management

Document management

The company has established a sound quality management document system, and the company’s document system matches and conforms to the practical production quality management, and can correctly guide the practical production, and the GMP requirements have been strictly implemented during the production process. All activities can be proved by documents and records, and procedures and records are available for the formulation, review, approval, issuance, recall and destruction of documents.

06

Production management

Production management

Production in is organized in strict accordance with approved specifications and technological procedures. Weighing and review by batch is carried out according to batch production instructions, and documents can guide production work correctly.
The intermediate products are managed by specially designated personnel, and the production sites, equipment and containers are clearly marked with status. Complete site-clearing can be achieved for the products of different varieties or of the same variety with different strengths and different batch numbers, and the site-clearing records are included in the batch production records.

07

Quality control and quality assurance

Quality control and quality assurance

The Quality Management Department of the company consists of Quality Assurance Division and Quality Control Division, responsible for the supervision and quality control of the whole process of production.
The establishment of QA in the production workshops, warehouses and other departments can effectively complete the quality supervision function of the whole process of production. Management documents and SOPs can correctly guide the practical work, management personnel at various levels to check the quality at each level, unqualified raw materials will not be put into use, unqualified intermediate products will not flow into the next process, finished products that do not meet the specifications will not leave the factory;
QC is now equipped with instruments such as high performance liquid chromatograph, Malvern laser particle size analyzer, infrared spectrophotometer, UV-visible spectrophotometer, pH meter, polarimeter, moisture meter, electro-heating standing-temperature cultivator and many other main inspection instruments and meters, which are suitable for our company's existing production scale, varieties, and inspection requirements.