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.
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:
- Jersey Shore, PA, USA
- Eschweiler, Germany
- Waterford, Ireland
- Kinston, NC, USA
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.