Overview of the quality management system
The company is equipped with enough qualified personnel, plant, facilities and equipment to provide necessary conditions for the realization of quality objectives.
A product quality management system has been established to minimize the risks of contamination, cross-contamination, confusion and errors in the production process. All the requirements of safety, effectiveness and quality control of products have been systematically implemented into the whole process of product production, control, product release, storage and delivery. Ensure Sustained and stable production of auxiliary products in accordance with the intended use and compliance requirements.
Quality assurance and quality control
The company establishes a quality assurance system and a completed documentation system to ensure the effective operation of the system.
The company is equipped with appropriate facilities, equipment, instruments and trained personnel to effectively and reliably complete all quality control related activities.
Organization and Personnel
The company establishes a management organization suitable for the production of products and clearly defines the responsibilities of each department and each post. The quality management department of the company is completely independent and the head of quality management and the head of production management do not hold concurrent posts with each other. The quality management department participates in all quality-related activities and is responsible for reviewing all documents related to GMP.
All personnel are trained in hygiene requirements to minimize the risk of contamination of product production. The production personnel who are in direct contact with the products shall receive the health check before taking up the post and shall have the health check once a year.
Plant and Facilities
The site selection, design, layout, construction, modification and maintenance of the plant conform to the production requirements of the product to minimize contamination, cross-contamination, confusion and errors, and facilitate cleaning, operation and maintenance.
The company has a clean production environment; The ground, road surface and transportation of the factory do not cause pollution to the production of products; The overall layout of production, administration, living and auxiliary areas are reasonable and don’t interfere with each other; The people and logistics in the factory and factory are reasonable.
Appropriate measures are also taken to prevent unauthorized entry.
Equipment
The production equipment does not have any adverse effect on product quality. The production equipment in direct contact with the product is 304 or 316L stainless steel, the surface is smooth, smooth, easy to clean or disinfect, corrosion resistant, does not react with the product, adsorb the product or release substances into the product. The lubricants used in the equipment are edible grade or equivalent. The equipment is cleaned entirely with purified water in accordance with the requirements of pharmacopoeia.
Major weighing instruments, measuring tools, meters, recording and control equipment and instruments used in production and inspection are calibrated to provide accurate and reliable data.
Materials and product management
The raw materials used in the production of the products and the packaging materials in direct contact with the products meet the pharmaceutical standards. The supplier has been approved by quality management department.
The disposal of unqualified materials, intermediate products, products to be packed and finished products are approved by the head of quality management. Each packaging container shall be marked clearly and conspicuously, and shall be properly kept and recorded in the isolation area.
The company establishes operating procedures for returning products and keeps corresponding records.
Validation and Verification
The company's plants, facilities, equipment and inspection instruments are certified. The production process, standard operation and product quality inspection are carried out by using validated protocol.and maintain at a continuous validation state.
Documents management
The company establishes standard operating procedures for document management, systematically designs, formulates, reviews, approves and issues. The documents related to this specification shall be reviewed by the quality management department.
The content of the document is consistent with the requirements of product production license, product registration and filing, and helps to trace the historical situation of each batch of products.
The production management
All products are manufactured and packaged in accordance with the approved process and operating procedures and are recorded to ensure that the products meet therequired quality standards and the product manufacturing license / registration.Protect products and materials from microbial and other contamination at every stage of production.
Access to the manufacturing facility is restricted to authorized personnel.
Product quality management
Product quality standards include the control of impurities (e.g. organic impurities, inorganic impurities, residual solvents). The corresponding limit standards for microorganisms were established. The continuous stability of the product was investigated.
Self-inspection
The quality management department organizes self-inspection of the enterprise every year, monitors the implementation of the GMP standard, evaluates whether the enterprise meets the requirement of GMP standard, and puts forward necessary CAPA.
Product delivery and recall
The enterprise has established a product recall system, which can recall any batch of products with hidden safety risks from the market quickly and effectively when necessary. Each shipment is recorded. Based on shipping records, it is possible to trace the sales of each batch of products and, if necessary, to recover them all in a timely manner.
The person in charge of product recall is the QA Manager, and the company conducts a mock recall every year.
