Janet Gaboury

Janet Gaboury, PhD

Sr. Specialist Regulatory Affairs

十月 21, 2019

Gamma Sterilization Process DMFs Harmonized

West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.

Gamma Sterilization

As part of this effort, RA has recently harmonized two of the Westar® RU Gamma Process DMFs into a single DMF, now titled Pharmaceutical Gamma Sterilization Process. There are no changes to the current manufacturing process and controls performed at the West facilities, and this action was only to consolidate multiple DMFs into a single harmonized DMF to reduce regulatory burden and to simplify the filing for customers buying gamma sterilized product from multiple sites.RA is pleased to announce that the following sites are now able to supply gamma sterilized commercial products under one harmonized process DMF with the appropriate regulatory filings in place.Pharmaceutical Gamma Sterilization Process DMF:

West Facilities: 

  • Jersey Shore, PA, USA
  • Eschweiler, Germany
  • Waterford, Ireland
  • Kinston, NC, USA
  West strives to simplify regulatory filings in support of our customers. Contact a Regulatory Affairs representative or visit the sterilization page or the Westar Select page on our website for more information.

 

 

Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

Recommended Blogs

色姑娘精品六 青龙| 信宜市| 历史| 福清市| 中卫市| 普宁市| 长沙县| 南京市| 临沭县| 漯河市| 光山县| 阳朔县| 敦化市| 太仓市| 噶尔县| 乌海市| 湖南省| 抚松县| 兰考县| 从江县| 任丘市| 佳木斯市| 溆浦县| 大同市| 界首市| 青川县| 尉犁县| 霍林郭勒市| 青铜峡市| 河津市| 双流县| 都匀市| 中西区| 马公市| 崇文区| 星座| 哈密市| 龙里县| 饶河县| 吴桥县| 大同县| http:// http:// http://