Fenretinide 100mg Softgel cGMP Batch Manufacture Sample Clauses

Fenretinide 100mg Softgel cGMP Batch Manufacture. Cardinal Health will perform activities as outlined below: • Order excipients in sufficient quantities and sample for release. • Perform release testing and QNQC release of all excipients based on ID test (additional cost if full release tests are required — included in Analytical Support section). • Obtain drug substance from Sytera, store under designated conditions, and release (ID) for use. • Finalize batch record. • Select/release/quarantine equipment for manufacture. • Manufacture enough quantity of Fenretinide 100mg softgels active fill to provide [* * *] softgels per theoretical batch size. • Encapsulate softgels. • Perform in-process fill weight and seal thickness. • Dry, wash, and bulk package softgels for shipment to Cardinal Health Packaging Services in Philadelphia, PA for final packaging. • Complete QA audit of batch paperwork. • Provide all batch paperwork and lot release documentation to Sytera. • Properly dispose of all waste material.
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