The supervision of the pharmaceutical packaging material industry is becoming more and more strict, and enterprises need to strengthen standardized management

Pharmaceutical packaging materials, as the name implies, are the packaging materials of medicines, which are part of medicines and play a role in protecting the quality and safety of medicines during the packaging, storage, transportation and use of medicines
.
It is understood that the quality and safety of the pharmaceutical packaging material itself, the compatibility between the pharmaceutical packaging material and the drug, etc.
will affect the quality of the drug, so the development of the pharmaceutical packaging material industry has always been concerned by the country and the industry
.
Especially with the rapid development of China's pharmaceutical industry, in recent years, the state's supervision of the pharmaceutical packaging industry has obviously begun to tighten continuously
.
For example, on August 26, 2019, the newly revised "Drug Administration Law" clearly stipulates that when examining and approving a drug, the relevant excipients, packaging materials and containers that directly contact the drug shall be reviewed together; and the use of unapproved direct Medicines produced in contact with the packaging materials and containers of medicines shall be treated as inferior medicines and counterfeit medicines
.
In addition, in the "13th Five-Year Plan", in the field of medicine, it also clearly stated that the focus should be on realizing the improvement of the pharmaceutical packaging industry, cooperating, promoting and guiding the development of pharmaceutical preparations, ensuring the goals and paths of drug quality and drug safety, and adapting to the diversified pharmaceutical industry.
development needs
.
It is worth noting that under the background of the country's increasingly strict supervision of pharmaceutical packaging materials, the supervision and spot checks of the pharmaceutical packaging material industry are constantly being strengthened in various places
.
For example, in order to strengthen the quality supervision and management of packaging materials and containers that come into direct contact with drugs and ensure the safety of public medication, according to the 2021 work plan for quality supervision and sampling inspection of pharmaceutical packaging materials in Shandong Province, the Shandong Provincial Food and Drug Administration will organize regional inspection branches to conduct inspections on pharmaceutical packaging in the province.
Material production enterprises and pharmaceutical packaging material users carried out supervision and sampling, and the inspection was carried out by Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection (Jinan Pharmaceutical Packaging Material Inspection Center of the State Food and Drug Administration)
.
According to the notice, Shandong Province will complete a total of 235 batches of sampling inspections of pharmaceutical packaging materials in 2021, focusing on the supervision and sampling of high-risk pharmaceutical packaging materials in the province and the varieties of pharmaceutical packaging materials that failed the previous year's sampling inspection
.
After inspection, 232 batches met the standard requirements, and 3 batches did not meet the standard requirements
.
The three batches of non-conforming items are easy to oxidize, solvent residue, and easy to oxidize medicinal aluminum foil.

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It is reported that the regulatory authorities have taken control measures such as sealing up, ordering to stop production and use, and supervising and disposing of pharmaceutical packaging materials that do not meet the standards in this announcement; The regulatory authorities have investigated and dealt with in accordance with the law
.
The industry believes that, judging from the current national and even local supervision of the pharmaceutical packaging industry, the entire industry will accelerate its development in the direction of high quality and standardization
.
In this context, major pharmaceutical companies, pharmaceutical packaging material manufacturers, and quality inspection agencies all need to attach great importance to the quality of pharmaceutical packaging materials and continuously strengthen the standardized management of pharmaceutical packaging materials
.
In the future, if the pharmaceutical packaging industry wants to achieve better development, it also needs to actively adapt to the new development and requirements of the pharmaceutical industry through continuous upgrading
.