SINGAPORE--The Chinese Pharmacopoeia Commission (ChP) and Waters ($WAT) launched their Joint Open Laboratory on Jan. 28 in Beijing that aims to produce the first official compendium of drugs, covering Traditional Chinese and Western medicines, and provide information on the standards of purity, description, test, dosage, precautions, storage, and strength.
The agreement was signed in July with intentions to contribute positively to assuring quality control of drugs in China. It is expected that this analytical laboratory will become a national technical support center advancing standardization and screening within the field of Chinese pharmaceutical standards.
China has faced severe food and drug quality and adulteration issues and last year drastically reorganized its inspection regime under the China FDA, along with new standards for good manufacturing practices that companies must obtain certification for. In addition, penalties and inspections have been stepped up, including allowing, at least on paper, more inspectors from the U.S. FDA to inspect facilities where products are bound for export.
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| Mike Harrington |
"Opening and operating this laboratory in China with ChP reflects our commitment to consistently push the boundaries of what's possible by helping to bring more resources to bear, enabling innovations in China's pharmaceutical and biopharma industries" said Mike Harrington, president of Waters Asia Pacific and European Operations, at the ceremony.
Spanning more than 400 square meters, located within the laboratory building of the Beijing Zhendong Guangming Drug Research Institute and outfitted with chromatography and mass spectrometry technologies from Waters, the facility is equipped to support pharmacopoeia standards in China.
The opening ceremony was attended by officials from China's pharmacopeia supervisory bodies, representatives from Chinese pharmaceutical enterprise and industry professionals and technicians. Future construction and operation prospects for the laboratory were reviewed.
The ChP is the authoritative and official compendium of drugs since 1950. It is an affiliated commission of the China Food and Drug Administration (CFDA) and is officially recognized by the World Health Organization.
- here's the release