Institutional and personnel management
The company has established an organization that is compatible with GMP management, and the heads of production and quality management departments do not concurrently serve each other. Head of enterprise quality, engineer, licensed pharmacist, university degree, engaged in chemical management for more than 20 years. The person in charge of production, engineer, university degree, engaged in chemical production quality management for more than 20 years.
Plant and facility management
The layout of the plant area is generally reasonable and the areas are relatively separated. There is no source of pollution around. Greening of the plant area, the road meets the requirements of GMP production.
The laboratory area is 768 square meters, the layout is reasonable, the rooms are complete, and the inspection department regularly checks and verifies.
According to the relevant regulations, the warehouses are divided into finished product warehouses, raw material warehouses, and dangerous goods warehouses. The materials are stored in a fixed position, and the status marks of the qualified products and the products to be inspected are obvious, and there are unqualified areas and return areas.
The design, selection and installation of the equipment meet the requirements of the production process and are easy to clean and disinfect. The selection and precision of instruments, meters and scales are in line with the production and inspection requirements. The provincial and municipal metrological testing institutes and statutory testing agencies are responsible for the periodic verification and verification, and the verification certificates are attached. All kinds of equipment, instruments and weighing instruments are provided with corresponding operation, maintenance, maintenance procedures. The equipment is managed by special personnel, regularly maintained and maintained, and has corresponding records.
Warehousing has obvious regional divisions that do not cause cross-contamination. The sample is a 300,000-class clean sampling vehicle that meets the sampling requirements of the inner packaging material. The company's original and auxiliary materials procurement are seeking qualified, reputable, audit qualified suppliers.
Unqualified raw and auxiliary materials will be put into the non-conforming product area, and the red sign board will be hanged, and the non-conforming product management system will be implemented.
The company set up the Quality Assurance Department, which has QA and QC and GMP offices, and is directly under the leadership of the general manager, responsible for quality monitoring and inspection of the whole process of pharmaceutical production. QA is responsible for the quality control of the whole process, the quality audit of the supplier, the supervision of the production process, the product quality complaints and the adverse reaction monitoring report; QC is responsible for the inspection of the raw materials, intermediates, finished products, process water and air cleanliness of the whole plant. And issue an inspection report form; the GMP office is responsible for self-inspection at the end of each year, and forms a self-inspection report. The defects found in the self-inspection are rectified within a time limit and the results of the rectification are tracked.
Each product has established technical procedures and standard operating procedures according to the registration process. When the revision is made, the approval procedures are carried out according to the relevant documents and relevant verification is carried out. If there are major changes to the process, the customer is notified in advance and reported to the local food and drug administration for approval. .
Batch production records are designed according to process procedures and standard operating procedures. According to the regulations, one year after the expiration date, the whole production process of the batch of products can be traced according to the production batch number, including the influence of the initial raw materials on the batch of products.
The batch number is in compliance with the requirements and has strict written regulations.
Document and record management
The company has established a relatively complete quality management document system. Documents and records cover all aspects of GMP management. All activities related to production, quality, storage and transportation are clearly defined in the file system. All activities pass documents and records. Both can prove that there are procedures and records for the formulation, review, approval, issuance, recovery and destruction of documents.
Product sales and recalls
Each batch of products has a sales record. According to the sales record, the batch number of the outbound product can be traced. If the quality problem is found, it can be recalled in time, and a written procedure is established. The relevant management system is formulated for the user's quality complaints and adverse reactions. Handle in time.