Wah Yan imperial Pharmaceutical has invested nearly 500 million yuan in Qingdao, Suzhou, Jiangsu has established three major production bases, with the production of solutions, tablets, capsules and the like more than twenty formulations and traditional Chinese medicine extract as one of the many forms of development the comprehensive production capacity, can be put into an annual output of 2 billion tablets, capsules 2 billion, granules 20 million bags and other products in various dosage forms, is put into an annual output value exceeded 20 billion yuan.
1 water treatment system
The process according to claim configured purified water treatment system. Pressurized raw water, sand filters, activated carbon filters, reverse osmosis softening into the host, through the United States Hyde can reverse osmosis system after processing into pure water tank. Water storage and distribution systems are made of 304 stainless steel, according to GMP requirements of the installation, the ultraviolet disinfection for recycling, Water quality requirements "Chinese Pharmacopoeia" standards for purified water.
2 from cans
This equipment is designed for the pharmaceutical cook mention section design, the device unit and its auxiliary equipment with more than a minute to complete the extraction process of traditional Chinese medicine, such as atmospheric, water to cook, heat reflux, percolation, aromatic oil extraction. Indirect heating system using steam, slag door with pneumatic actuator to turn on and lock, who are in contact with the drug at the 304 stainless steel has good corrosion resistance, to ensure that the quality of Chinese medicine products.
3 three-effect energy-saving concentrator tank
This equipment is used to extract the herbs, the liquid from the dilute solution in this heating cycle three times concentrated liquid feed continuous evaporation, concentration is increased until the desired proportion of energy conservation. Evaporation tank, 304 stainless steel pipe mused, according to GMP requirements to install equipment designed to meet GMP requirements.
4 universal grinder
The machine consists of pulverizer, material collecting box and cleaner composition, solve the material in the process of crushing dust flying. The machine has a self-cooling system to solve the usual problems fever mill operation, high grinding efficiency, grinding fineness of 60-120 mesh material, uniform and stable product fineness. 304 stainless steel, equipment designed to meet GMP requirements.
5 vibration sieve
The machine consists of hopper, vibration chamber, coupling and motor. The whole structure is compact, small size, no dust, high yield, easy to move maintenance. 304 stainless steel, equipment designed to meet GMP requirements.
6 wet mixing granulator
This equipment is added in one of several recipes work container, after mixing adhesive is injected, or one with a binder formulation work was added in one container, after mixing by the stirring paddle made of soft material, soft cut reamer minced granulated material. Mixing and cutting equipped with two-speed motor, and automatically controlled by time relay, obtained by adjusting the particles of different sizes. Who are in contact with the drug at the 304 stainless steel, equipment designed to meet GMP requirements.
7 hot air circulation oven
The use of steam as a heat energy to produce heat with steam radiators. Use fan convection heat, the material for heat transfer, and continue to add fresh air and exhaust humid air, the use of process control automatic temperature control. Carts and trays made of 304 stainless steel, equipment designed to meet GMP requirements.
8 three-dimensional motion mixer
The devices barrel arm is fixedly connected by a universal turn two, and separately with the drive shaft, the driven shaft is linked, driven by the drive shaft, as the cycle of translation, rotation and other composite tumbling run, prompting the materials are mixed in the cylinder three-dimensional composite body for running, achieve mutual flow of a variety of materials, diffusion, accumulation, blended thoroughly mixed in a short time, while avoiding the proportion of general mixer materials due to the centrifugal force generated by the phenomenon of segregation and accumulation, mixing no dead ends, can be very homogeneously mixed good fluidity powder or granular material, effectively ensure the best quality of mixed raw material. Who are in contact with the drug at the 304 stainless steel, equipment designed to meet the requirements of GMP
The machine through the rotary screen with special friction tie rod friction collision crushed solid particles while grinding chunks of polymer, the dried granules through a suitable size screen, the particles obtained in line with the requirements. Who are in contact with the drug at the 304 stainless steel, equipment designed to meet the requirements of GMP
10 capsule filling machine
It is a fully automatic capsule filling machine, the host, auxiliary equipment, electrical control box, capsules, powder hopper and the hopper and other components. Automatic capsule filling into the powder, and is equipped with different molds can be filled with numbers from 0 to 4 capsules, the speed can be adjusted as needed, which uses intermittent motion and multi-position plugs measurement methods. U-turn AutoComplete capsules, sub-sac, filling and rejection, co-sac, and so the whole process of the introduction of the finished product filled capsules. Contact portion of the agent does not react with the drug occurred, in line with GMP standards, all the moving parts to wear small, ergonomic. The machine has a novel structure, advanced design, adjustable dosage, safety protection, statistics output timing, the capsule machine high rate of production data can be printed and so on. Equipment designed to meet the requirements of GMP
11 Automatic Blister Packaging Machine
+ Plate combination is a roller type of plastic blister packaging machine. The machine is controlled by computer, fully enclosed work, the host operating speed variable speed, each section can be individually debugging. Contact portion of the agent does not react with the drug occurred, in line with GMP standards, all the moving parts to wear small, ergonomic. The machine has a novel structure, advanced design, adjustable dosage, safety protection, statistics output timing characteristics.
12 automatic plastic bottle packaging line
Production lines are connected by a conveyor belt through six equipment, machine, electricity, gas as one for tablets, capsules finished packaging, automated packaging production. Comprehensive set of advanced equipment and reasonable structure design, tight connection between devices, conveyor accurate position. Equipped with electronic counting machine counting pipeline photodetector means when each pill after, will produce a corresponding pulse signal of load accurately. Capper by the cover and lock the cover composition, is the upgrading of traditional capping machine replacement products, capping speed. Sealing machine adopts advanced line, selecting the latest US fifth-generation transistor power module components. Labeling machine operating system by the PLC and industrial control terminal composition, labeling and printing batch while completing the operation. Entire parts in direct contact with the material are made of stainless steel, no dead ends, easy to clean, and the selection of materials, cleaning agents unreactive. Equipment designed to meet GMP requirements. Production line consisting of: LP700 governor on the bottle, CZG80 / 16 Electronic Counting machine, SZ100 automatic desiccant inserted into machine, SG100 linear automatic capping machine, DG-1500B electromagnetic induction sealing machine, TBY100 self-adhesive labeling.
1, Material Management System
Drugs used in the production of purchased materials are developed, inspection, storage, distribution and use of the system. Developed raw materials, packaging materials, intermediate and finished products and the quality standards appropriate inspection procedures.
The company has strict supplier audit management procedures, the audit materials are purchased from qualified suppliers, according to the provisions of the project inspection, after passing the storage.
Press material physicochemical properties, the different types, classification, partition is placed. By species, size, batch number registration number recorded, strictly enforce the payment system, FIFO. Quarantined, qualified materials be strictly supervise the management. Substandard materials storage area, and there are clearly marked for easy identification.
Drug labels, instruction manual design after approval by the QA before printing, pharmaceutical labels, brochures and printed with the same label packaging material storage area to implement, according to the production and issuance of instruction count, and strictly enforce the issuing labels refunding system. Destruction of excess label at QA supervision.
Treasury pest control mice, anti-mosquito, anti-pollution measures dust. There are temperature and humidity monitoring and logging facilities.
2, health management
Requirements workshop, process, post production and air cleanliness according to the cleaning procedures developed plant, equipment, containers, etc., including: cleaning methods, time intervals, the cleaning method using the cleaning agents and cleaning tools and storage location.
Each step must obtain clearance certificate issued by QA personnel to produce.
Developed different levels of clean dressing procedures, depending on the production level is set different clothes, clothes for strict management, classification regularly cleaned and disinfected.
Entering the clean zone must be changing according to changing rules of order, unauthorized persons can not enter the production area. Foreign visitors is subject to ratification by the supervised purified dressing in clean areas.
Company direct contact with drugs production and management personnel at least once a year health check, skin diseases, infectious diseases and surface wounds who are not allowed to contact the production of drugs. Physical examination unqualified personnel immediately removed from production-related jobs. The company has health records, to ensure the production and inspection personnel qualifications for operators meet the health requirements of GMP.
3, Authentication Manager
To ensure that all equipment and technological activities of the company is reliable and stable state, production and quality activities comply with the GMP requirements of major equipment and major craft workshop verified. The company was established in Xinjian Jie, head of the verification team, responsible for verifying the leadership, develop verification plan, establish project verification and approval verification report issued certificate verification; validation project team responsible for implementing the verification work, the preparation of the program verification, validation reports submitted draft . Predetermined cycle air purification system, water system, key equipment (extraction and concentration, the total finishing mixture, dry granulation, etc.), equipment cleaning and crafts are verified by all equipment, utilities and process conditions meet the production requirements, it is possible produce acceptable quality medicines.
4, file management
According to the GMP requirements, the preparation of the management procedures of production management and quality management, quality control department has developed a document management procedures, file encoding management procedures, document change management procedures and other documents, the establishment of a more comprehensive document management system, a clear the role of quality assurance management system. According to company documents management procedures required the drafting, revision, review, approval, revocation, printing and storage, distribution, existing files are text files that have been revoked and fault except on file for reference purposes, have been destroyed, not working the scene. File management program to achieve standardization.
File system is divided into two parts: the standard type of documents and records. Wherein the standard class file more than 400 copies, recorded more than 160 copies of classified documents detailed in FIG.
Enterprise standards are divided into: management standards, technical standards, work standards.
Records are divided into: the process of recording, accounting records, vouchers record.
5, production management
In accordance with the GMP requirements of the development of the product process planning, post standard operating procedures and other documents and strictly enforced, by the process of identification and verification to ensure quality implementation.
Each lot of products each company has a corresponding batch records, batch production records with production order for each production process by the production department issued. The whole production process of the production process records. According to the production quota picking instruction, send materials, ingredients, and review of key processes, finished products for mass balance. Abnormal happens material balance deviations occur and the production process, according to "deviation handling procedures" for processing, to ensure the quality of manufactured products.
When changing batch or replacement of species must be cleared and cleared disinfection, after the clearance by the QA staff for inspection, after passing the issue a "clearance certificate."
Equipment, materials, hygiene, process management execution state flag, indicating the operational status of equipment, contents of the container name, batch. Pipeline with different contents indicate the name, its flow direction indicated by arrows. Measuring instruments are used by the metrology department hand check, posted verification certificate and a check records.
6, quality management
(1) Quality Supervision
Responsible for the establishment of quality assurance system supervision, and ensure their normal operation.
Organization responsible for preparing the company GMP documents, audits, issuance of work and supervise their implementation.
Responsible for the establishment of raw materials, intermediates, packaging materials, labels and finished goods release or rejection system; responsible for approval of the product quality of raw materials, semi-finished and finished products for quality evaluation.
Responsible for developing the company verification program verification programs and their implementation.
Responsible for GMP self-test work, the implementation of GMP inspection, and promptly correct the error, and supervise the implementation of corrective action plans.
Responsible for product quality, management of technical documents, development of enterprise standards of products; responsible for approving the technical rules, sampling methods, quality standards, test methods and other quality control procedures.
Responsible for evaluation of the batch record review before deciding to release the audit has been completed key steps of batch production and laboratory control records, to ensure that all significant deviations are investigated and corrective actions have been.
Responsible for handling user complaints, to ensure the quality related complaints were investigated and dealt with appropriately; responsible for product quality regularly review and audit.
Responsible for the approval and supervision shall be borne by the entrusted commission inspection.
GMP is responsible for training and training materials to prepare employees and to ensure that this sector-based professional staff through training and continuing training.
It is responsible for determining the classification of measuring instruments and calibration cycle press program organized and implemented.
Responsible for the whole process of production of dynamic monitoring, inspection and maintenance of this department, plant and equipment, to ensure that there is stability data to support retest of intermediate or finished product / expiry dates and storage conditions.
Batch files and save files related to GMP.
(2) Quality Inspection
Responsible for the inspection of raw materials, auxiliary materials, intermediate and finished products, the environment, and an inspection report to ensure the accuracy of test results.
Participation in testing methods, quality standards development and modification, responsible for revising the relevant SOP.
Responsible for inspecting work within the company to stay kind of products, timely provision of information on the stability of the product.
Participating companies to verify the relevant inspection work.
Responsible for the daily management of the laboratory.
7, product sales and recovery
Developed a product shipping management procedures, medicines return and recall management procedures and strict implementation of the provisions of the grant must be recorded product can be sold to trace each batch of products, product returns, and recover a strict examination and approval procedures, including: Name , batch number, specifications, quantity, return and recovery unit address, causes and treatment advice, due to quality reasons for return and recovery of products, quality supervision department under the supervision of the destruction, and simultaneously record when it comes to other batches.
8, complaints and adverse reactions
According to the company's specifications called for medicines complaints recovery management procedures and management procedures of adverse drug reactions, complaints and adverse drug reactions with a special department responsible for processing, detailed recording process; the development of the drug quality management incident reporting procedures to production of major quality problems arise, timely, factual report to the local drug regulatory department.
9, the self-test
The company in addition to receiving the drug regulatory department of drug supervision and inspection of the production process, but also in accordance with the GMP norm-setting self-test management procedures, regular internal review, according to a predetermined procedure, to institutions and personnel, buildings and facilities, equipment, materials, health, verification, documentation, production management, quality management, drug sales, customer complaints and product recovery processing and other projects carried out a comprehensive inspection, the establishment of self-test directory, the formation of a self-test report, issued a rectification notice on failed projects, rectification department rectification within the time limit and pass the inspection, to ensure that the current management and specification. To meet the GMP certification examination, I organize a self-test results meet the GMP requirements.