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Hefei Kangchuntang Pharmaceutical Co., Ltd.
Address: No.13, Branch Road, Biomedical Park, High-tech Zone, Hefei City, Anhui Province
Telephone:0551-63830999/63673366
Warmly celebrate our company's successful passage of GMP certification and acquisition of the certificate
Release time:
2018-05-17
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In February 2018, the company successfully passed the on-site inspection for China's 2010 GMP certification.
In February 2018, the company successfully passed the on-site inspection of China's 2010 version of GMP certification and obtained the GMP certificate on May 10, becoming a pharmaceutical production enterprise that passed the new version of GMP certification.
From February 8th to 10th, 2018, the expert team of the new version of GMP on-site inspection and acceptance organized by the Anhui Provincial Food and Drug Administration's Drug GMP Certification Review Center conducted a comprehensive audit and inspection of our company's implementation of the new version of GMP. Through three days of intensive work, the expert team did not find any serious defects in this on-site inspection and acceptance, and the overall evaluation fully meets the requirements of the new version of GMP, successfully passing the on-site inspection and acceptance. In the inspection and acceptance process, the expert team, based on the principles of fairness and impartiality, and with a serious and responsible attitude, checked against the provisions of the newly issued "Good Manufacturing Practice for Drugs (2010 Revision)", mainly focusing on the company's quality management system, personnel hygiene, material storage and distribution, plant facilities, production management, validation and confirmation, deviation and change investigation and handling, production processes, product shipment and recall, and document systems, conducting assessments item by item. Through various forms such as listening to reports, comprehensively reviewing materials, inspecting the site, asking questions collectively, and conducting individual spot checks, the experts fully grasped the actual situation of each inspected item, leaving no small detail unchecked, thus obtaining an objective, true, and accurate evaluation. Our company successfully passed the on-site inspection and acceptance of the new version of GMP with a sound quality management system, advanced production equipment and processes, and standardized quality management procedures.
The successful passing of the company's GMP certification fully demonstrates the company's employees' spirit of unity and courage to forge ahead. It is the result of the joint efforts of all employees of the company. This also shows that our team is a cohesive team, a team that can fight tough battles, and a team full of vigor! We believe that we will achieve even more brilliant achievements in the future!