Problems and Countermeasures in the supervision of

Problems and Countermeasures of the drug packaging material jianleeb hardness tester is a portable hardness tester tube

drug packaging material is the packaging material and container that directly contacts drugs. The quality of drug packaging materials has a great impact on the quality of drugs. Because drug packaging materials may bring bacteria and other microorganisms, some harmful substances in the packaging materials may be dissolved by drugs, resulting in drug pollution; At the same time, some components in the drug may be adsorbed by the packaging material during the packaging and storage process, or react with the packaging material, which directly affects the drug quality or dosage. Therefore, to ensure drug safety, we must strengthen the supervision of drug packaging materials

according to the letter on conducting research on drug packaging material manufacturers issued by the Municipal Bureau, Gongshu branch conducted research on drug packaging material manufacturers under its jurisdiction. The relevant information is as follows:

I. Basic information

there are 2 drug packaging material production enterprises in the jurisdiction, with a total of 5 products holding the "drug packaging material registration certificate". According to the product catalogue, the main varieties are: medical hard PVC, multi-layer co extrusion infusion bags, etc

II. Existing problems

(I) the overall quality of personnel in drug packaging material production enterprises is not high, especially the quality and ability of inspection personnel

the staff training plan is not targeted, the records are incomplete, and some staff training records are not established for one person and one file; Original inspection record This article comes from Zhonghua packaging bottle The record is relatively simple, and there is no inspection operation procedure. According to the original record, it is difficult to trace back to the specific links where errors occur in the inspection process; The finished product bags before filling liquid are not inspected, etc

(II) the hardware facilities are not perfect, and the testing instruments can not keep up with the requirements

some enterprise workshops are old, the area of the clean workshop is small, and there is a lack of container storage room, etc; The temporary storage of packaging materials in the purification workshop and the storage of sanitary ware in the sanitary ware room are not standardized; The layout of hygiene limit room is not reasonable, and there is a lack of positive bacteria control room; The configuration of testing instruments is incomplete, such as tensile strength and heat sealing strength without testing equipment

(III) production quality management is not standardized

the content of production records is not complete, and the production process records are incomplete, which brings hidden dangers to production quality

III. problem analysis

(I) the laws and regulations on the supervision of drug packaging materials are not perfect.

drug packaging materials are the registration certificate management that combines production and registration. For the production of drug packaging materials, it is only necessary to obtain the registration certificate of drug packaging materials, and there is no need for a production license. The registration right of class I drug packaging materials is in the National Bureau, and the registration right of class II drug packaging materials is in the provincial drug administration department. Almost all enterprises that quickly unload the packaging materials directly report to the Provincial Bureau without going through the two-level drug administration departments in the urban area. The daily supervision work is carried out in the grass-roots drug supervision departments at the urban level, resulting in some grass-roots This article comes from Zhonghua packaging bottle The drug administration department is not clear about the production evidence collection of drug packaging material enterprises in its jurisdiction

Order No. 13 of the State Food and Drug Administration "measures for the administration of packaging materials and containers in direct contact with drugs" only stipulates the punishment for the use of unqualified drug packaging materials, but how to determine whether the drug packaging materials are unqualified and whether the drug packaging materials that have not been fully inspected by the manufacturer of drug packaging materials can be determined as fake drug packaging materials as drugs, There are no clear regulations on how to punish the units using drug packaging materials that have not been inspected (not necessarily all qualified products)

there are no laws and regulations on the packaging, label management and use management of drug packaging materials. Drug manufacturers should do compatibility tests on drug packaging materials, but they can't find relevant clear regulations. There are no corresponding requirements for the packaging labels of drug packaging materials

(II) the testing ability of drug packaging material enterprises is not enough

it is difficult for drug packaging material enterprises to fully equip with testing instruments, and it is even more difficult for drug manufacturing enterprises and hospital preparation rooms (especially hospital preparation rooms) to have all the instruments for drug packaging material testing. Therefore, drug manufacturing enterprises using drug packaging materials cannot do the compatibility test between drug packaging materials and drugs, and it is difficult to ensure the quality of drug packaging materials

III. regulatory countermeasures

(I) improve the laws and regulations on the supervision and management of drug packaging materials

it is suggested to formulate more operational supervision and management methods for the supervision of the production and use of drug packaging materials, so as to make the daily supervision scientific, standardized and procedural, so as to promote the improvement of the quality management level of enterprises

(II) introduce the certification system of GM vibration frequency of 2500 (3000) times per minute as soon as possible.

it is suggested to also carry out GMP certification for drug packaging material manufacturers to fundamentally ensure the quality of drug packaging materials from the source. The implementation of GMP certification for drug packaging materials enterprises will promote the normal competition and healthy development of the drug packaging materials industry

(III) strengthen the construction of testing institutions and testing capacity

it is suggested that the Municipal Drug Inspection Institute improve the testing items of drug packaging materials, such as the physical testing items of drug packaging materials. It can not only meet the regulatory requirements, but also solve the problem that the drug packaging materials cannot be fully inspected in one region, and it can also achieve resource sharing in one region. Enterprises are required to strengthen the allocation of general testing instruments and testing capabilities, and entrust drug packaging material testing institutions to test items that cannot be done with limited conditions, such as infrared and abnormal toxicity tests. The units using drug packaging materials should also specify the inspection items that must be done to ensure the quality of drug packaging materials

(IV) strengthen training

in view of the weak technical strength of professional quality managers and inspectors in drug packaging materials enterprises, it is hoped that the National Bureau and the Provincial Bureau can compile books on drug packaging materials and organize training and learning, and strengthen the training of drug packaging materials standards, inspection, compatibility test of drug packaging materials and drugs, Improve the quality of pharmaceutical packaging materials enterprises. In 2016, the total shipment volume of domestic lithium power battery enterprises reached 30.5gwh, including volume awareness, standard awareness and testing level. At the same time, it is required that the quality management and inspection personnel of drug packaging materials must reach the corresponding professional and technical capabilities and implement the post access system