Sodium calcium glass infusion bottle son 3 batches of "drug package material" sampling is not qualified

Recently, Shandong Provincial Drug Administration issued a "drug package material" quality supervision and sampling notice, according to the 2019 Shandong Province drug package material quality supervision and sampling work plan, Shandong Provincial Drug Administration organized the municipal market supervision bureau of the province's pharmaceutical packaging production enterprises, drug packaging material suing units carried out supervision sampling, the National Food and Drug Administration Jinan Pharmaceutical Packaging Materials Inspection Center to carry out inspection
The circular shows that in 2019 the Bureau completed a total of 201 batches of drug package material sampling (including 27 batches of emergency sampling), focusing on the high-risk drug package material in Shandong Province and the previous year's sampling of unqualified drug package varieties to supervise and samplingAfter inspection, in line with the standard provisions 198 batches, does not meet the standard provisions of 3 batches
From the sampling does not meet the standard sleuth list of 3 batches of varieties, the drug package materials involved are sodium calcium glass infusion bottle, PVC solid medicinal hard tablets, low-density polyethylene medicinal eye drops bottle, not in line with the project's appearance, easy oxide, appearance
Shandong Provincial Drug Administration said that the announcement does not meet the standardprovisions of pharmaceutical package materials, the regulatory authorities have been in accordance with the law to seal, order the suspension of production and use, supervision and treatment of control measures;
Drug packaging material is direct contact with the pharmaceutical packaging materials and containers, its quality will directly affect the stability of drugs and the people's drug safetyTherefore, it is very important to strengthen the inspection of the amount of material of the drug package and the daily supervision of the pharmaceutical package production enterprises
In recent years, in order to further standardize and improve the quality standards of pharmaceutical package materials, unified inspection methods and technical requirements, strengthen the supervision of pharmaceutical package materials, China's drug package material standards are also constantly improving
From December 1, 2015, 130 current effective drug package material standards, "National Drug Pack Material Standards" 2015 version of the official implementation, the establishment and improvement of pharmaceutical accessories, drug package material standards system is also the "Chinese Pharmacopoeia" 2020 edition of the preparation of one of the focus
According to the 2020 edition of the Pharmacopoeia, the chemical composition of medicinal glass materials should meet the requirements of product performance, the production should strictly control the chemical composition of raw materials and formulations, the uniformity of the material and melting quality, to ensure the accuracy, stability and uniformity of the glass composition; It is reported that in terms of pharmaceutical package materials, the National Pharmacopeia Commission from 2015 to 2019 a total of 36 varieties of subjects, method-type topics 27, some of the completed research work, the relevant standard system of revised draft has been announced
With the intensive release of the national draft standards for pharmaceutical package materials, industry standards continue to improve, the pharmaceutical package material industry will move towards high-quality, standardized directionSome experts said that how to strengthen the production quality management of pharmaceutical package materials, improve the quality level of pharmaceutical package materials, is an important issue in front of drug-related practitionersIn the current strict supervision, the standard severing background, pharmaceutical package material production enterprises also need to continuously improve the quality management level of production, improve the quality of pharmaceutical package materials
The author learned that in recent years, with the country's increasing attention to the amount of drug package material, drug package testing instrument technology is also improving, further ensure that the enterprise's drug package-related standards within a reasonable range.