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Source: Yaodu Written by: Dripping Sinan Editor: Maruko
Packaging materials and containers in direct contact with drugs (hereinafter referred to as "pharmaceutical packaging materials") refer to the packaging materials and containers in direct contact with drugs used for drugs produced by drug manufacturers and preparations prepared by medical institutio.
As an important part of medicines, pharmaceutical packaging materials ensure the performance of medicines to a large exte.
The quality of pharmaceutical packaging materials has an important impact on the safety, effectiveness and stability of drugs, and plays a key role in formulation and producti.
Along with the entire process of drug production, circulation and use, it is directly related to drug quali.
The construction of policies and regulations for the supervision and management of pharmaceutical packaging materials is a gradual process from scrat.
In 1981, the State Pharmaceutical Administration promulgated and implemented the "Administrative Measures for Drug Packaging", and encouraged the pharmaceutical packaging industry to organize the formulation of relevant pharmaceutical packaging product standar.
In 1998, more than 20 pharmaceutical packaging product standards such as ampoules and glass infusion bottles were successively released; In April 2000, the State Food and Drug Administration promulgated the "Administrative Measures for Pharmaceutical Packaging Materials and Containers (Interim)", which clarified the registration management of pharmaceutical packaging materials; the newly revised "Drug Administration Law" in 2001 clarified the laws of pharmaceutical packaging materia.
On June 18, 2004, the former State Food and Drug Administration promulgated and implemented the "Packaging of Direct Contact Medicines.
Materials and Containers Management Measures" [Order .
13 of the Bureau], strengthens the supervision and management of pharmaceutical packaging materials, and clarifies that pharmaceutical packaging materials produced, imported and used in China must comply with the pharmaceutical packaging materials formulated by the State Food and Drug Administration National standard; There are 6 series of "Compilation of Packaging Materials and Container Standards for Direct Contact Drugs" issued in succession from 2002 to 2005, containing a total of 139 varieties of pharmaceutical packaging materials standards, measurement methods, guiding principles, e.
, December 2015 The "National Standards for Pharmaceutical Packaging Materials (2015 Edition)", which was implemented on the 1st, revised and improved the original 139 standards for pharmaceutical packaging materials, merged and improved some standards, and finally formed 130 national standards for pharmaceutical packaging material.
The national pharmaceutical packaging material standards have played an important role in the quality control of pharmaceutical packaging materials and have promoted the healthy and rapid development of the domestic pharmaceutical packaging material industr.
), metal (5), plastic (36), rubber (4), pre-potting (11), other (1), method (47) seven categori.
The guidelines for the existing standard system of pharmaceutical packaging materials in "National Standards for Pharmaceutical Packaging Materials (2015 Edition)" are shown in the following table:
The existing pharmaceutical packaging material standards are mainly formulated based on the original pharmaceutical packaging material registration system, which cannot meet the existing drug related review and approval and pharmaceutical packaging materia.
1
Thinking and progress of the construction of the standard system for pharmaceutical packaging materials in the Chinese Pharmacopoeia
Packaging materials and containers in direct contact with drugs (hereinafter referred to as "pharmaceutical packaging materials") refer to the packaging materials and containers in direct contact with drugs used for drugs produced by drug manufacturers and preparations prepared by medical institutio.
As an important part of medicines, pharmaceutical packaging materials ensure the performance of medicines to a large exte.
The quality of pharmaceutical packaging materials has an important impact on the safety, effectiveness and stability of drugs, and plays a key role in formulation and producti.
Along with the entire process of drug production, circulation and use, it is directly related to drug quali.
The construction of policies and regulations for the supervision and management of pharmaceutical packaging materials is a gradual process from scrat.
In 1981, the State Pharmaceutical Administration promulgated and implemented the "Administrative Measures for Drug Packaging", and encouraged the pharmaceutical packaging industry to organize the formulation of relevant pharmaceutical packaging product standar.
In 1998, more than 20 pharmaceutical packaging product standards such as ampoules and glass infusion bottles were successively released; In April 2000, the State Food and Drug Administration promulgated the "Administrative Measures for Pharmaceutical Packaging Materials and Containers (Interim)", which clarified the registration management of pharmaceutical packaging materials; the newly revised "Drug Administration Law" in 2001 clarified the laws of pharmaceutical packaging materia.
On June 18, 2004, the former State Food and Drug Administration promulgated and implemented the "Packaging of Direct Contact Medicines.
Materials and Containers Management Measures" [Order .
13 of the Bureau], strengthens the supervision and management of pharmaceutical packaging materials, and clarifies that pharmaceutical packaging materials produced, imported and used in China must comply with the pharmaceutical packaging materials formulated by the State Food and Drug Administration National standard; There are 6 series of "Compilation of Packaging Materials and Container Standards for Direct Contact Drugs" issued in succession from 2002 to 2005, containing a total of 139 varieties of pharmaceutical packaging materials standards, measurement methods, guiding principles, e.
, December 2015 The "National Standards for Pharmaceutical Packaging Materials (2015 Edition)", which was implemented on the 1st, revised and improved the original 139 standards for pharmaceutical packaging materials, merged and improved some standards, and finally formed 130 national standards for pharmaceutical packaging material.
The national pharmaceutical packaging material standards have played an important role in the quality control of pharmaceutical packaging materials and have promoted the healthy and rapid development of the domestic pharmaceutical packaging material industr.
), metal (5), plastic (36), rubber (4), pre-potting (11), other (1), method (47) seven categori.
The guidelines for the existing standard system of pharmaceutical packaging materials in "National Standards for Pharmaceutical Packaging Materials (2015 Edition)" are shown in the following table:
With the development of new technologies, new packaging materials have been widely used in the packaging indust.
The existing pharmaceutical packaging material standards are mainly formulated based on the original pharmaceutical packaging material registration system, which cannot meet the existing drug related review and approval and pharmaceutical packaging materia.
2
In line with international standards, the 2025 edition of "Chinese Pharmacopoeia"
Accelerate the construction of a standard system for pharmaceutical packaging materials
3
summary
The Chinese Pharmacopoeia standards have received extensive attention from all parties involved in the research and development, production, use, review and supervision of pharmaceutical packaging materials and dru.[1]China Modern Applied Pharmacy, China Drug Standards, CPHI, e.
