欧盟洁净区环境监测.pdfVIP

更多GMP资料 (资料来源于互联网) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market : management legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations Brussels, 30 May 2003 Ad Hoc GMP Inspections Services Group EC GUIDE TO GOOD MANUFACTURING PRACTICE REVISION TO ANNEX 1 Title: Manufacture of Sterile Medicinal Products st 1 DRAFT ADOPTED BY AD HOC GMP INSPECTORS GROUP October 2002 RELEASED FOR PUBLIC CONSULTATION November 2002 – January 2003 FINAL DRAFT ADOPTED BY AD HOC GMP INSPECTORS April 2003 GROUP ADOPTED BY PHARMACEUTICAL COMMITTEE May 2003 DATE FOR COMING INTO OPERATION September 2003 Note: Annex 1 of the EC Guide to Good Manufacturing Practice (GMP) provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance includes recommendations on standards of environmental cleanli- ness for clean rooms. The guidance has been reviewed in the light of the international stan- dard EN/ISO 14644-1 and amended in the interests of harmonisation but taking into account specific concerns unique to the production of sterile medicinal products. The changes affect section 3 of the annex together with a minor change to section 20. The remainder of the annex remains unchanged. 更多GMP资料 (资料来源于互联网) ANNEX 1 MANUFACTURE OF