Kongshengtang Pharmaceutical currently has six dosage forms including granules, pills, tablets, capsules, oral liquids, and dripping pills. Its leading products include Shuangdan Granules, Yikang Capsules, and Shuangdan Dropping Pills. There are also nearly 100 over-the-counter Class A and Class B Chinese patent medicines with independent intellectual property rights, such as "Gardenia Golden Flower Pills", "Liuwei Dihuang Pills", "Wuji Baifeng Pills", etc. for the treatment of common and frequently-occurring diseases. variety.
"Shuangdan Granules" is a national-level new drug for the treatment of cardiovascular and cerebrovascular diseases jointly developed with the China Academy of Traditional Chinese Medicine. It has accurate efficacy, safety and reliability, no toxic side effects, independent intellectual property rights, and is exclusively produced in China. A protected variety of traditional Chinese medicine, entered the national medical insurance product catalog, won the "First Prize for Scientific and Technological Progress", and was included in the National Spark Plan. Yikang Capsule is a fifth-generation Ginkgo leaf compound preparation jointly developed with the Wuhan Institute of Botany, Chinese Academy of Sciences. It is a patented health product. Its technical standards exceed the international standards of similar products and won the "Gold Medal of the Hong Kong International New Products and New Technology Expo".
In September 2003, the pills, granules and capsules of Shandong Kongshengtang Pharmaceutical Co., Ltd. passed the on-site inspection of the Certification Center of the State Food and Drug Administration for the first time and obtained the GMP certification. In September 2008, it passed the renewal of certification. This marks that the production quality management of Kongshengtang has moved towards standardization, standardization and modernization.
According to GMP requirements, the company has established and improved production and quality management organizations. The functions and job responsibilities of each department are clearly defined in documents.
The company has various technical personnel suitable for the production scale.
The factory building has a clean area of ??300,000 level and a general production area. The factory layout is scientific and reasonable, the production process has no roundabouts, and each production process is clearly differentiated, without overlap or interference with each other.
Various warehouses have sufficient area and space suitable for production; production is equipped with intermediate stations to accommodate intermediate products.
The company has formulated management procedures, including organization and personnel, factories and facilities, equipment, materials, sanitation, verification, documents, production management, quality management, quality inspection, self-inspection management, user complaint management and defective products Response reporting, sales and repossession, etc.
The company has established various records for production, quality management, equipment, and health management.
The company has established GMP document classification and numbering management procedures, and standardized management of the drafting, revision, review, approval, withdrawal, printing, and storage of GMP documents.
Strictly implement the requirements of batch number management during the production process. To avoid contamination and confusion of drugs, quality supervisors will inspect the production site before production, and production can only proceed after passing the inspection. Equipment and containers used in the production process have obvious status signs. After the completion of each batch of production in each process. Clear the area in accordance with the standard operating procedures for area clearance. And fill in the clearance record.
The process water meets the quality standards and is inspected regularly by the Technical Supervision Bureau and a conformity report is issued. Purified water is prepared using the reverse osmosis method and is inspected monthly with inspection records.
The enterprise technology research and development department is responsible for the quality management and inspection of the entire process of drug production. The quality department is directly led by the person in charge of the enterprise. The quality inspection center has various laboratories, sites, instruments, and equipment that can meet the production scale. , varieties, and inspection requirements.
The Technology R&D Department is responsible for formulating and revising internal control standards for material intermediate products and finished products; responsible for formulating and revising inspection operating procedures for material intermediate products and finished products; formulating sampling and sample retention systems; formulating inspection equipment and instruments , reagents, test solutions, standard solutions, culture media management methods; determine the use of materials and intermediate products: review batch production records before product release; decide product release; review irregular product handling procedures; sample materials, intermediate products and finished products Inspect and retain samples and issue inspection reports; monitor the clean room and the number of dust particles and microorganisms: evaluate the quality stability of raw materials, intermediate products and finished products, and provide data for determining the storage period of materials and drugs; formulate the responsibilities of quality management and inspection personnel, and work with the supply department Evaluate the quality system of major material suppliers; organize quality analysis activities regularly; be responsible for the recording, investigation and reporting of adverse reactions; be responsible for quality accidents and investigation, analysis, processing and reporting: test returned products and provide processing opinions; be responsible for quality reports Responsible for the summary and reporting work; Responsible for organizing the quality management team activities of the whole factory; Responsible for the process supervision of drug recovery when necessary; Responsible for the management of product quality files; Responsible for the training of quality management and quality inspection personnel; Responsible for providing inspection operations for verification Specify sampling methods, implement inspections and issue inspection reports; be responsible for the formulation and implementation of equipment cleaning, product process and other verification plans, and be responsible for the supervision of the handling of unqualified drugs.
The company has established adverse reaction reporting procedures and user quality complaint management procedures, established an after-sales service department, and has dedicated personnel responsible for investigating and handling adverse reactions and quality complaints, and recording them.
The company has set up a self-inspection team to conduct regular inspections on personnel, factories, equipment, documents, production, quality management, drug sales, user complaints and product recall processing.
We deeply realize that passing GMP certification is only the starting point, and there is a long way to go to implement GMP. We are determined and confident to adhere to the implementation and continuous improvement of GMP in future production and operation management, and make Kongshengtang Pharmaceutical bigger and stronger. Continuously make new and positive contributions to meet the needs of society.