Objective: To compare and analyze the current regulations and standards on the clean environment of pharmaceutical packaging materials at home and abroad, and to find out the existing problems and aspects for improvement in the clean environment of pharmaceutical packaging materials in China. Methods: By comparing the similarities and differences of the relevant regulations and standards, it is found that the regulations and standards in China are to be updated and improved, and the existing problems of the clean environment of the pharmaceutical packaging materials are pointed out with reference to the current situation of the industry. Results: Chinese GMP and the EU GMP are generally consistent, but there are still gaps in the test methods and quantity requirements of some parameters in some standards. There are still some defects in the routine monitoring and parameter verification of pharmaceutical packaging material manufacturers in China. Conclusion: The regulations and standards of clean environment for pharmaceutical packaging materials in China have been in line with international standards, but some provisions still need to be updated and improved. There are still some problems in the area of clean environment for drug packaging materials in China, so it is necessary to further promote the implementation of relevant laws and standards to promote the overall quality of clean environment.
Tian Lin, Yang Huiying, Sun Huimin
. Comparative Study on Regulations and Standards of Clean Environment for Pharmaceutical Packaging Materials[J]. Chinese Pharmaceutical Affairs, 2020
, 34(1)
: 22
-32
.
DOI: 10.16153/j.1002-7777.2020.01.004
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