|
|
|
 17/07/2009
[Industry news]
New draft GMP guidelines completed, software/SOPs a focus
The review and evaluation of the draft of the new Good Manufacturing Practice (GMP) guidelines has been completed and will be sent to the State Council for approval, according to an expert from the State Food and Drug Administration (SFDA)
|
| |
|
The review and evaluation of the draft of the new Good Manufacturing Practice (GMP) guidelines has been completed and will be sent to the State Council for approval, according to an expert from the State Food and Drug Administration (SFDA), as reported by Medicine Economic News.
The draft, which was completed in April 2009, modifies four \'appendices\' of the original 1998 version of the GMP guidelines- drug sterility, traditional Chinese medicine (TCM) dosages, active pharmaceutical ingredients (API), biological products, and the \'basic requirement\' section. The new version also adds a new blood products appendix. Most of the revisions are focused on improvements in quality and protocols rather than lab equipment and facilities. |
|
|
|
|
