In-Process Testing definition
Examples of In-Process Testing in a sentence
Transfer qualified analytical methods from Sponsor for cGMP In-Process Testing, In-Process Control, and Drug Substance / Drug Product release testing.
The Agreement is hereby amended by replacing Exhibits B (In-Process Testing Procedures and Specifications) and C (Product Release Test Methods and Specifications) with Exhibits B-1 (CMC section of the Cubist U.S. NDA filing) and C-1 (Master Product Specifications) attached hereto.
APC will develop the Batch Production Record and In-Process Testing prior to the initiation of the production of Product intended for use in clinical trials.
Perform In-Process Control testing and/or In-Process Testing [*] as required by the process.
Appearance [**] [**] [**] Assay by HPLC [**] [**] [**] In-Process Release Testing [**] In-Process Testing: [**] GMP Total Appearance [**] [**] [**] Assay by HPLC [**] [**] [**] Dissolution (n=6) [**] [**] [**] In-Process Release Testing [**] In-process Testing [**] Total Estimated Analytical [**] Based upon the method complexity, Catalent reserves the right to amend estimated costs.
R&D-grade VB-111 In-Process Testing The following analyses will be performed by Lonza Process Development personnel on VB-111 samples taken throughout the GMP production process: [***] [***] [***] [***] [***] [***] [***] [***] Analysis activities will be documented in laboratory notebooks and the results reported to VBL in an electronic Excel file.