In-Process Testing definition

In-Process Testing means all testing activities of In-Process Materials performed during the Processing to ensure that such In-Process Materials conform to in-process specifications.
In-Process Testing means the quality assurance testing performed during production of Product to monitor and adjust (if necessary) the manufacturing process to ensure that final Product conforms to the Specifications and the production environment and equipment is controlled in compliance with cGMP.

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.

Related to In-Process Testing

  • Cannabis testing facility means an entity registered by

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • Start-Up Testing means the completion of applicable required factory and start-up tests as set forth in Exhibit C.

  • Commissioning test means tests applied to a distributed generation facility by the applicant after construction is completed to verify that the facility does not create adverse system impacts and performs to the submitted specifications. At a minimum, the scope of the commissioning tests performed shall include the commissioning test specified in Institute of Electrical and Electronics Engineers, Inc. (IEEE) Standard 1547 Section 5.4 "Commissioning tests".

  • In process means the student has received at least one dose of the required immunizations and is waiting the minimum time interval to receive the additional dose(s).