Good manufacturing practices GMP packing machine：

The so-called GMP refers to a complete set of management systems to ensure product quality, from the quality of personnel and production operators responsible for guiding product production quality control to production plants, facilities, buildings, equipment, warehousing, production processes, quality management, process hygiene, packaging materials and labels, and even the storage and sales of finished products. In short, the basic point of GMP is to ensure product quality, and it is necessary to prevent mixed batches, mixed contamination and cross contamination of products in production.

The basic content of GMP involves personnel, plants, equipment, sanitary conditions, starting materials, production operations, packaging and labeling, quality control systems, self-inspection, sales records, user opinions and adverse reaction reports. In terms of hardware, there must be an environment, plant, and equipment that meet the requirements; in terms of software, there must be reliable production processes, strict management systems, and a complete verification system.

Its main contents can be summarized as follows.

Well-trained - production staff, management personnel
Appropriate - plant, facilities, equipment
Qualified - raw materials, auxiliary materials, packaging materials
Experience-proven - production methods
Reliable - monitoring measures
Perfect - after-sales service
Strict - management system

At present, GMP is widely implemented in most countries and organizations in the world. The regulations on air cleanliness in various countries and organizations in the implementation of GMP have both similarities and differences. For any air cleanliness level, GMP stipulates both the maximum allowable number of dust particles and the maximum allowable number of microorganisms. The number of dust particles is controlled to be ≥0.5 μm, and the number of microorganisms is controlled to be the upper limit of the number of floating bacteria per unit. The names of the EU GMP air cleanliness levels are different from those of the Chinese GMP. It is generally believed that the EU's Claaa A and Claaa B are equivalent to China's Class 100; Claaa C is equivalent to China's Class 10000, and Claaa D is equivalent to China's Class 100000. Claaa A and Claaa B are 100 levels, but generally B reflects the clean room, and A refers to the local purification area with stricter requirements. The air cleanliness level is different. China's GMP air cleanliness level is divided into four levels: 100, 10000, 10000, and 300000; Japan's is divided into three levels: 100, 1000, and 100000; the US FDA is divided into two levels: 100 and 100000; the EU is divided into four levels: A, B, C, and D. China's GMP requires static testing and dynamic monitoring, while Japan and the United States require dynamic compliance and stipulate dynamic test indicators; while the EU has regulations on the number of dust particles in both dynamic and static states, and only stipulates dynamic test indicators for the number of fungi.

Contents of GMP specifications:
The content of GMP specifications includes both hardware and software.
Hardware refers to the material conditions that must be available to ensure that production enterprises correctly implement specifications and prevent product contamination, including plant facilities, production equipment, and testing equipment. Software refers to the management system, management organization, management standards, process procedures, record reports, etc. formulated to ensure that the hardware can operate normally and prevent contamination due to errors or human errors. Guangke has rich practical experience in GMP whole plant planning. In the actual operation process, Guangke's GMP workshop planners have listed the following issues that need attention based on the problems encountered.

In the implementation of GMP specifications, the following issues should be paid attention to.
(I) Strict requirements and careful planning must be made for the transformation of research and development parts
The logistics (raw materials, semi-finished products, finished products) and personnel (operators, management personnel) in the factory should be reasonably designed and each should go its own way to avoid contamination of the final product due to the cross-mixing of personnel and logistics. The factory should have sufficient use and reasonable layout of changing rooms, buffer rooms, logistics storage rooms, operation rooms, inspection rooms and other places.

The indoor packaging production line should be carefully and specialized in plane and three-dimensional layout design. The direction of each work equipment is reasonable and the spacing is sufficient. The intermediate products are stored in an orderly manner to adapt to the rhythm of the product assembly line to avoid operational errors. Dongguan Guangke Precision Machinery has rich experience in GMP whole plant planning, especially in deoxidizer GMP whole plant planning and desiccant industry planning. Dongguan Guangke is the only one in the world.

The air purification facilities in the operating room are strictly designed according to GMP standards (cleanliness, ventilation frequency, etc.). Air flow design is done according to GMP requirements to prevent secondary flying of air dust particles and reduce the occurrence of air vortex. To prevent the infiltration of outdoor unclean air, the air pressure in the clean room must be effectively controlled to maintain a certain positive pressure.

Effectively prevent cross contamination of packaged products. Minimize the adverse effects of dust, water vapor, microorganisms, staff clothes and other pollution sources in the processed raw materials, strictly limit the production and packaging of products in different isolation areas, avoid producing different products in the same isolation area, and the handling of raw materials should also be carried out in a closed environment.

(II) Effective control of product quality
The purpose of the product quality assurance system is to ensure that the production of products meets its final use requirements. Since the product is directly related to the life safety of the user, there are strict requirements for its packaging. In countries around the world, products are special commodities that are strictly controlled.

Good manufacturing practices GMP packing machine