ZhengYe company is take the lead in domestic construction and production of animal vaccines factory in according? with the international GMP standards
There are 4 production workshops with a total floor area of 912,00 square meters and a total purification area of 10,500 square meters.
Total 14 production lines:1diluent production line;3 for cell live vaccine ;3 for cell inactivated vaccine;1 for bacteria live vaccine;1 for bacteria inactivated vaccine;1 for chicken embryo live vaccine;1 for chicken embryo inactivated vaccine;1 for cell suspension live vaccine;1 for cell suspension inactivated vaccine;1 for Genetically engineered vaccine lines
The company now has 35 items products, with an annual production capacity of 28 billion ml/dose,The production capacity of the pig vaccine product is 16 billion ml/dose.
In May 2016, it invested 120 million to build a vaccine suspension culture workshop,With a floor area of 7,700 square meters and a purification area of more than 5,400 square meters,Mainly producing pig vaccine products, there are 6 floating cell culture and sub-unit gene engineering production lines in total.And the only domestic production line for freeze-dried inactivated vaccines,Passed the GMP acceptance of the ministry of agriculture in September 2017.
The equipment selected by the production workshop is international and domestic first-class brand
The only sub-assembly line of freeze-dried products in the domestic animal biological products industry which adopts the automatic feeding and discharging system.Minimize the involvement of people in the production process to ensure product quality;
The internationally advanced German SARTORIUS bioreactor is used to concentrate and purify the viral stock solution while realizing suspension culture, so as to ensure that the product quality is in line with international standards and provide users with high-quality, efficient and even products.
2015 built 3000 square meters of animal experiment center and intelligent animal temperature measurement system, Simultaneous multi-animal testing and quality evaluation of vaccine products.
1 Purpose: To establish quality management system, which to strengthen the quality control of the entire process and comprehensively improve product quality.
2 Scope of application: Company quality management
3 Responsible: Manager of quality management, manager of quality control, responsible of each department
4 Text: The quality management system is the main body of management for all functions and activities necessary to achieve quality. It includes the make relevant? ?quality policies, the determination of quality levels or objectives; as well as the related products processes or services of both inside and outside the company that management the quality assurance, quality control and organizational measures.?
4.1 System composition Quality management system of the company has consists of two parts, one is the quality assurance system, and the other is the quality control system. The person in charge of quality is an important position in the company's quality management work, coordinating with the quality management of all processes in production.?
4.2 Staff composition Chief Engineer, Manager of Quality Management Department, Manager of Quality Management Department, Auditor of Quality Management Department, Quality Supervisor of Quality Management Department, Quality Inspector of Quality Control Department, Semi-Quality Inspector, Quality Leader of Production Group Product, Animal Tester, Buyer of the purchasing department of the raw materials, the warehouse manager, the sales department, the head of the energy equipment department and related personnel.
4.3 Main tasks and permissions?
4.3.1 Responsible for the material inspection, management system's formulation, revision and review, report to the department manager for approval.
4.3.2 Formulate inspection items and detailed standard operating procedures of materials.
4.3.3 Responsible for sampling, inspection, sample retention, and issue inspection report on materials.
4.3.4 The authority to outbound permissions the raw materials, semi-finished products and finished products.
4.3.5 The authority to determine to use the internal and external packaging materials, labels, instructions.
4.3.6 The authority to dispose returned drugs and sub-quality products.
4.3.7 Responsible for formulating materials sampling and retention system, material storage period and drug expiration date.
4.3.8 Responsible for quality stability evaluation of raw materials, semi-finished products (intermediate products) and finished products, and providing data for determining the storage period of materials, the expiration date of drugs or the quality responsibility period.
4.3.9 To assess the storage conditions of raw materials, semi-finished products (intermediate products) and finished products.
4.3.10 Responsible for formulating management methods of equipment, instruments, reagents, solutions, poisons, drugs, standards (or reference products), standard solutions, culture media and laboratory animals.
4.3.11 Responsible for monitoring the counts of dust, live microorganisms and the quality of various production waters.
4.3.12 Responsible for formulating the responsibilities of full-time and part-time quality inspectors, ensuring the normal operation of their work.
4.3.13 Responsible for the professional training of full-time and part-time quality inspectors, and participate in the company's training and education on the Good Manufacturing Practice of Animal Drugs and the quality awareness of products.
4.3.14 Regularly report the quality of biological products to the China Institute of Veterinary Drug Control and accepts its business guidance.
5 Permanent institutions: The Quality Management Department and the Quality Control Department are the permanent establishments of the company's quality management. They are responsible for the daily work of quality management and accept the business guidance of the China Institute of Veterinary Drug Control and the provincial Institute of Drug Inspection.
Production management is carried out in full and strict accordance with the ‘requirements of the new version of the veterinary drug production quality management specification’ (GMP). The quality management department and the quality inspection department are set up and operated independently.
1.All the key raw materials use the leading products of the same industry both at home and abroad.
2. Implement supplier access system and audit system for raw and auxiliary materials, and conduct field visits to suppliers every year;
3. The bulk raw materials shall be inspected twice before and after entering the factory and purchased in whole batch;
4. Establish production process specifications and standard operating procedures (SOP) for each product;
5. All raw and auxiliary materials and finished products shall be prepared for internal control standards of the enterprise, and shall be inspected according to the standards.After passing the inspection, it can be put into storage.
6. All kinds of core control and testing equipment use international leading brands;
7. Each batch of products has accurate and complete production records, inspection records and sales records;
8.360-degree video surveillance throughout the production area.