Enable batch release or specialized batch comparability under full cGMP with Covance to meet the European Annex 13 cGMP and other guidelines. You benefit with Covance's full range of strategies and techniques using a subset of characterization assays to release your formulated product. Covance can also provide specialized batch comparability studies.
- Data reporting flexibility for your individual needs
- Stand-alone testing documents for information purposes
- certificate of analyses for individual production lots
- Single, comprehensive batch release testing documents
- Technical and quality assurance expertise
- Rapid turnaround, efficient management
- Close communication with you, manufacturing groups and Qualified Persons
Batch and lot release testing on bulk harvest material
Assays are performed by Covance on a case-by-case basis for monitoring of product bulk harvest in case of a breakdown in GMP.