Peak pharmaceutical eye drops, ear drops workshop successfully passed the new GMP certification


Release time:

2013-06-28


From April 10 to 12, the GMP certification inspection team of Zhejiang Food and Drug Administration conducted a three-day on-site dynamic inspection of the workshop. Five experts from the inspection team inspected the production workshop, warehouse, central laboratory, water treatment system, air conditioning purification system, etc., and reviewed the production records, inspection records, verification scheme, verification report and other documents. After on-site inspection and review, the inspection team unanimously agreed that Jianfeng Pharmaceutical has a sound organization, clear functions, environmental sanitation standards in the factory area, and reasonable production workshop process design, but there are some defects in production quality management. According to the improvement opinions put forward by the inspection team, the pharmaceutical company immediately arranged personnel to carry out rectification. The Certification Center of Zhejiang Food and Drug Administration reviewed and confirmed the inspection report, inspection records and rectification of the pharmaceutical company by the inspection team, and believed that the production quality management system of the workshop met the requirements of the "Good Manufacturing Practice for Drugs (Revised in 2010)", and officially announced on June 27, agreeing to issue a drug GMP certificate.
This certification is the "first big test" of Jianfeng Pharmaceutical after the promulgation and implementation of the national "Pharmaceutical production quality Management Standard (revised in 2010)". In order to meet the requirements of the new version of GMP as soon as possible, the pharmaceutical company held several special meetings, actively organized training, and conveyed and implemented the theme of the new version of GMP into the production quality management work. At the same time, in contrast to the new version of GMP, the relevant production management system and post operating procedures were revised and upgraded, and self-inspection and self-examination were carried out many times to lay the foundation for successfully passing the certification.
The passing of the new version of GMP certification in the eye drops and ear drops workshop not only improves the GMP management level of the pharmaceutical company, but also accumulates valuable experience for the new version of GMP certification for the raw materials, preparations and other production lines of Jinxi project next year.