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In addition, the Westar RS process produces elastomeric components that meet defined specification limits for particulates and bioburden. Process capabilities exist globally at West’s facilities in Eschweiler, Germany; Jersey Shore, Pa.; Jurong, Singapore; and LeNouvion, France. To help support a successful review by the FDA, drug manufactures contemplating a pharmaceutical regulatory submission in the U.S. should consider elastomeric components washed by West.
The transition to the Westar RS process isn’t as difficult as you might think. In June 2010, FDA issued the “Draft Guidance for Industry: CMC Postapproval Manufacturing Changes Reportable in Annual Reports,” which was intended as an adjunct to the existing “Guidance for Industry: Changes to an Approved NDA or ANDA (2004).” The draft guidance identified a new group of changes that are considered to be Annual Reportable including the following:
Use of a contract manufacturing organization (CMO) for the washing of a drug product stopper, provided the applicant certifies that the CMO’s washing process has been validated and the CMO’s site has been audited by the applicant (or by another party sponsored by the applicant) and found cGMP compliant.
West’s recent experience has been that this type of transition can be covered by a Changes Being Effected (CBE-30) submission, however the guidance indicates that the FDA views this kind of change as having minimal potential to impact drug product quality adversely.
Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.