Higher Threshold in Drug GMP Certification
Year:2007 ISSUE:36
COLUMN:NEW PRODUCT AND TECHNOLOGY
Click:320    DateTime:Dec.25,2007
Higher Threshold in Drug GMP Certification     

The new "Standard for the Examination and Evaluation of Drug Good Manufacturing Practice (GMP) Certification" that has received great attention will start implementation from January 1st, 2008. According to officials from the State Food and Drug Administration of China, the new standard has stricter requirements on drug quality and further intensified the supervision on weak links of the quality management in drug manufacturers.
   The "Standard for the Examination and Evaluation of Pharmaceutical GMP Certification" is formulated on the basis of quality management codes in drug production. The purpose is to set a uniform standard for inspectors in making examination and evaluation. The standard currently in force was issued in 1999.