GMP is good manufacturing practice, in another words, product manufacturing and quality management requirement. WHO define GMP as directive of food, drug, medical devices production and quality management regulation. GMP is, essentially, establishing a systematic and complete quality system, prevent mistakes contamination and mix, give no chance to accidental event, make sure manufacturing safe, homogeneous, stable and conformity products.
GMP is a compulsory standard applicable to medical devices, drug, healthy care product and food, etc, requesting enterprise to meet the sanitary quality requirement from raw materials, staffs, infrastructures, processes, packaging and delivery, quality control as per state related regulation, then forming an operable practice to help improve manufacturing sanatory environment, timely finding problem in manufacturing process, and improving it. Briefly, GMP require manufacturer have good production equipment, suitable productive process, thorough quality management and strict inspection system, make sure final product quality (including food safety and sanitation)
Advantage of certification
1. Simplify working process, reduce working cost, promote working efficiency.
2. Support the evidence for healthy administrative departments, food healthy supervisor inspection
3. Provide basis for establishing international certification standards.
4. Meet custom requirement, promote products image.
5. Help manufacturing and sale staff know particularity of production, inspiring spirit of responsibility for product quality, eliminate bad habit of production.
6. Manufacturing enterprise has higher requirement for raw materials, accessories and package materials, conducive to utilize new technologies and new devices for manufacturer, and making sure the quality.
Reference materials
1. Enterprise general condition
1.1 Enterprise information
1.2 Enterprise manufacturing condition
1.3 GMP certificating scope this time
1.4 Major change information since last GMP certification
2. Enterprise quality management system
2.1 Description of enterprise quality management system
2.2 Final products release procedure
2.3 Supplier management and sub-contract, entrusted inspection information
2.4 Action of quality risk management
2.5 Yearly retrospective analysis of product quality
3. Human resources
3.1 Including quality assurance, manufacturing and quality control organizational diagram (including top management), and each department organizational diagram of quality assurance, manufacture and quality control;
3.2 Qualification of enterprise key person, assurance, manufacturing, quality control and main technicians.
3.3 The number of each department of quality assurance, manufacturing, quality control, storage and delivery.
4. Workshop, infrastructure and equipment
4.1 Workshop(overall workshop layout chart, manufacturing area layout chart and flow diagram, brief description of all manufacturing line layout information of applied certification scope)
4.1.1 Brief description of air-condition purification system
4.1.2 Brief description of water system (working principle of water system, design standards, operating condition and schematic diagram)
4.1.3 Brief description of other public infrastructure (such as compressed air and nitrogen working principle, design standards and operating condition)
4.2 Devices
4.2.1 List main instrument and device for manufacturing and testing
4.2.2 Washing and sterilizing
4.2.3 key computer system related to drug manufacturing and quality
Documentation (describe enterprise documentation system; briefly describe drafting, modification, approving, issuing, control and filing of documents)
6. Production
Documentation (describe enterprise documentation system; briefly describe drafting, modification, approving, issuing, control and filing of documents)
6.1 Product information (process flow chart of dosage form applied this time, and indicate major quality control point and item)
6.2 Process verification (brief describe principle and overall condition of process verification; principle of rework and reprocessing)
6.3 Material management and storage
7. Quality control
8. Delivery, complaint and recall
8.1 Delivery
8.2 Complaint and recall
9. Self-inspection (describe the self-inspection)
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