The direct contact of pharmaceutical equipment with pharmaceuticals, semi-finished products and raw materials is an important factor in the production errors and pollution of pharmaceuticals. Whether the pharmaceutical equipment meets the GMP requirements is directly related to the quality of the GMP implemented by the manufacturer. However, for a long time, it is often not valued in the GMP transformation of enterprises. The phenomenon of "new temple old bodhisattva" also exists in some enterprises that have obtained GMP certificates. The quality of the equipment determines the quality of the drug
Currently, the quality of pharmaceutical equipment is worrying. For example, in the washing and sealing joints, the smashing of the swarf is more prominent. According to some data, when an ampoule is broken, the particles that are inhaled more than 0.5 micron can reach more than 20,000. According to the current damage rate, how to remove these particles is not a small problem.
Moreover, it has been reported at home and abroad that after the ultrasonic washing of the ampoule, the vial and the infusion bottle, the epidermis is loose and brittle, and it is easy to fall off the particles when it is soaked for a long time. These phenomena are difficult to check with the naked eye, because the particles can be seen at least 50 microns above the surface, while the human micro-vessels are only a few microns thin, and many undetected particles can block blood vessels and cause blood clots; Many kinds of equipments such as pulverization, granulation, mixing, tableting and coating of solid oral preparations are not 316 steel. These equipments have rough welding and poor weld finish. The friction particles will be mixed into the medicine through friction with the material; Equipment with transmissions, due to poor sealing, mechanical wear and lubricant leakage and contamination of the drug is not a minority.
In short, due to the improper material structure of the equipment, the production errors and pollution caused by the drugs have reached a point that cannot be ignored. If compared with foreign pharmaceutical equipment, the gap is more obvious. Our products are rarely used in in-place cleaning (CIP), in-situ sterilization (SIP), electropolishing and other technologies commonly used abroad.
Raise awareness and promote execution
These problems are caused by production technology, material supply, market price, social support, etc., but one important reason that cannot be ignored is that many pharmaceutical equipment factories do not understand GMP, even though they have not forgotten the standard on the product description. On the "GMP-compliant" slogan, and what GMP means for pharmaceutical equipment, how to meet the basic requirements of GMP is not clear; objectively, due to institutional reasons, GMP promotion, training and other activities have not extended to the pharmaceutical equipment industry. , causing their lag in understanding. Therefore, it is necessary to promote GMP in the pharmaceutical equipment industry as soon as possible so that they can understand the meaning and sincerity of GMP from the ideological point of view and improve the product quality of pharmaceutical equipment in practice.
Evaluating whether a pharmaceutical device meets GMP requirements does not depend on its appearance. It depends on whether it has the following conditions: First, it meets the requirements of the production process; Second, it does not pollute the drug and the production environment; Third, it is conducive to cleaning, disinfection, and Sterilization; Fourth, to meet the needs of verification. These principles require that each device will have its specific content. How to carry out this evaluation work has caused the common concern of the production units and users of pharmaceutical equipment and become their common requirement.
At present, China's GMP certification work is limited to pharmaceutical manufacturers. As for other products closely related to pharmaceutical production, such as pharmaceutical equipment, it is not yet GMP certified. In the face of the uneven quality of pharmaceutical equipment and the mixed phenomenon, how to survive the fittest and keep up with the development needs of GMP, we must strengthen the standardization and standardization of pharmaceutical equipment and promote the technological progress of the pharmaceutical equipment industry.
The "Pharmaceutical Machinery GMP Review Committee" jointly established by the Pharmaceutical Machinery Technology Center and the Pharmaceutical Machinery Testing Center affiliated to the State Economic and Trade Commission has carried out the design, structure, standards, performance and testing of pharmaceutical machinery products two years ago. Technical review pilot work. The jury consists of senior personnel who have long been engaged in pharmaceutical production, design, research, teaching, management, etc., and uses third-party technical service methods to conduct GMP reviews on pharmaceutical equipment. However, only a few large-scale related enterprises have applied for and passed GMP certification to this day. There are still many things to be done in this work, and they also face greater resistance.
The review work has a long way to go
The GMP review of pharmaceutical equipment is different from the GMP certification of pharmaceutical companies. The former is a voluntary corporate act; the latter is a mandatory government act. Pharmaceutical equipment manufacturers can apply to the accreditation body according to their needs. The accreditation body will make an objective and fair evaluation through the comprehensive review results such as product testing and on-site inspection, and issue evaluation opinions or certificates. The GMP review of pharmaceutical equipment is also different from the new product identification. The former focuses on GMP, the object is all new and old products; the latter is surrounded by innovation, the object is new products. Both are different and neither repeat nor replace.
The basis for GMP review of pharmaceutical equipment is China's "Good Manufacturing Practices (1998 Revision)", which is China's GMP. The "equipment" and related chapters in China's GMP put forward the principle requirements for the pharmaceutical equipment involved in production. Based on this, the jury has established evaluation criteria for various pharmaceutical equipment.
The process of review is not only the process of promoting GMP to the pharmaceutical equipment industry, but also the process of communication between production units and users. The purpose of the review is to summarize the experience in practice, and on this basis, according to the requirements of the State Economic and Trade Commission, formulate the "Quality Management Specification for Pharmaceutical Machinery Design and Manufacturing". Thereby further standardizing the whole process management of pharmaceutical equipment from design to manufacturing and sales, and ensuring the quality of pharmaceutical equipment to keep up with the needs of GMP development.
Currently, the quality of pharmaceutical equipment is worrying. For example, in the washing and sealing joints, the smashing of the swarf is more prominent. According to some data, when an ampoule is broken, the particles that are inhaled more than 0.5 micron can reach more than 20,000. According to the current damage rate, how to remove these particles is not a small problem.
Moreover, it has been reported at home and abroad that after the ultrasonic washing of the ampoule, the vial and the infusion bottle, the epidermis is loose and brittle, and it is easy to fall off the particles when it is soaked for a long time. These phenomena are difficult to check with the naked eye, because the particles can be seen at least 50 microns above the surface, while the human micro-vessels are only a few microns thin, and many undetected particles can block blood vessels and cause blood clots; Many kinds of equipments such as pulverization, granulation, mixing, tableting and coating of solid oral preparations are not 316 steel. These equipments have rough welding and poor weld finish. The friction particles will be mixed into the medicine through friction with the material; Equipment with transmissions, due to poor sealing, mechanical wear and lubricant leakage and contamination of the drug is not a minority.
In short, due to the improper material structure of the equipment, the production errors and pollution caused by the drugs have reached a point that cannot be ignored. If compared with foreign pharmaceutical equipment, the gap is more obvious. Our products are rarely used in in-place cleaning (CIP), in-situ sterilization (SIP), electropolishing and other technologies commonly used abroad.
Raise awareness and promote execution
These problems are caused by production technology, material supply, market price, social support, etc., but one important reason that cannot be ignored is that many pharmaceutical equipment factories do not understand GMP, even though they have not forgotten the standard on the product description. On the "GMP-compliant" slogan, and what GMP means for pharmaceutical equipment, how to meet the basic requirements of GMP is not clear; objectively, due to institutional reasons, GMP promotion, training and other activities have not extended to the pharmaceutical equipment industry. , causing their lag in understanding. Therefore, it is necessary to promote GMP in the pharmaceutical equipment industry as soon as possible so that they can understand the meaning and sincerity of GMP from the ideological point of view and improve the product quality of pharmaceutical equipment in practice.
Evaluating whether a pharmaceutical device meets GMP requirements does not depend on its appearance. It depends on whether it has the following conditions: First, it meets the requirements of the production process; Second, it does not pollute the drug and the production environment; Third, it is conducive to cleaning, disinfection, and Sterilization; Fourth, to meet the needs of verification. These principles require that each device will have its specific content. How to carry out this evaluation work has caused the common concern of the production units and users of pharmaceutical equipment and become their common requirement.
At present, China's GMP certification work is limited to pharmaceutical manufacturers. As for other products closely related to pharmaceutical production, such as pharmaceutical equipment, it is not yet GMP certified. In the face of the uneven quality of pharmaceutical equipment and the mixed phenomenon, how to survive the fittest and keep up with the development needs of GMP, we must strengthen the standardization and standardization of pharmaceutical equipment and promote the technological progress of the pharmaceutical equipment industry.
The "Pharmaceutical Machinery GMP Review Committee" jointly established by the Pharmaceutical Machinery Technology Center and the Pharmaceutical Machinery Testing Center affiliated to the State Economic and Trade Commission has carried out the design, structure, standards, performance and testing of pharmaceutical machinery products two years ago. Technical review pilot work. The jury consists of senior personnel who have long been engaged in pharmaceutical production, design, research, teaching, management, etc., and uses third-party technical service methods to conduct GMP reviews on pharmaceutical equipment. However, only a few large-scale related enterprises have applied for and passed GMP certification to this day. There are still many things to be done in this work, and they also face greater resistance.
The review work has a long way to go
The GMP review of pharmaceutical equipment is different from the GMP certification of pharmaceutical companies. The former is a voluntary corporate act; the latter is a mandatory government act. Pharmaceutical equipment manufacturers can apply to the accreditation body according to their needs. The accreditation body will make an objective and fair evaluation through the comprehensive review results such as product testing and on-site inspection, and issue evaluation opinions or certificates. The GMP review of pharmaceutical equipment is also different from the new product identification. The former focuses on GMP, the object is all new and old products; the latter is surrounded by innovation, the object is new products. Both are different and neither repeat nor replace.
The basis for GMP review of pharmaceutical equipment is China's "Good Manufacturing Practices (1998 Revision)", which is China's GMP. The "equipment" and related chapters in China's GMP put forward the principle requirements for the pharmaceutical equipment involved in production. Based on this, the jury has established evaluation criteria for various pharmaceutical equipment.
The process of review is not only the process of promoting GMP to the pharmaceutical equipment industry, but also the process of communication between production units and users. The purpose of the review is to summarize the experience in practice, and on this basis, according to the requirements of the State Economic and Trade Commission, formulate the "Quality Management Specification for Pharmaceutical Machinery Design and Manufacturing". Thereby further standardizing the whole process management of pharmaceutical equipment from design to manufacturing and sales, and ensuring the quality of pharmaceutical equipment to keep up with the needs of GMP development.
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