Chinese Medical Doctor Association

North American Liaison Office


The newly revised Pharmaceutical GMP Inspection Standards issued

The State Food and Drug Administration (SFDA) recently issued the newly revised Pharmaceutical GMP Inspection Standards. The Standards further upgraded GMP inspection standards and intensified management. The Standards will be implemented as of January 1, 2008.

The newly revised Standards expanded from the previous 225 articles to 259 articles. Of which, key items (items with a "*" ahead) expanded from 56 to 92 and ordinary items changed from 169 to 167. Technical requirements on drug producers in personnel qualifications, production process, quality control and validation documentation are increased in order to intensify the supervision on quality management of drug producers and ensure drug quality.