Engineering Run definition

Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps.

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Engineering Run means a fermentation run, at the same scale as the intended GMP batch, conducted for the purpose of testing a manufacturing process, identifying and resolving any potential issues with equipment or cGMP documentation prior to clinical GMP manufacturing, and supplying material for non-clinical use and/or stability studies. An Engineering Run is not for the purpose of manufacturing Product in conformance with cGMP.

Engineering Run means a non-cGMP Manufacturing run utilizing Master Production Records and intended to execute the series of unit operations in the specified order to evaluate whether or not the Manufacturing Process meets draft Product Specifications. For Engineering Runs raw materials and equipment will be used as for intended later cGMP manufacturing. Raw Materials for non-cGMP purpose do not require incoming goods controls, but QA release based on supplier certificates. Suppliers do not need to be audited at this stage. The Engineering runs are performed in the same cGMP clean rooms facilities and by the same trained personnel as for the intended later cGMP manufacturing. Engineering runs will not include deviations or OOS reporting in IDT’s Quality System. Engineering runs will include review by Production Record review team, QC record review team and QA, but no QP release. Product from Engineering Runs shall be considered as Development Product pursuant to Section 2.10.

Examples of Engineering Run in a sentence

The Manufacturing Price, Campaign Report Fee, Engineering Run Price and Annual Program Fee specified in Attachment 1 shall increase first on [***] and then on [***] of the consecutive years in an amount [***], if any, [***].
Note: T=0 initial testing is covered in Stage 8: Engineering Run.
COBRA will invoice AUXILIUM monthly for the [****] Engineering Run.
X Staging of GMP manufacturing suites & suite activation X Client-specific Master Batch Records X Client-specific Sampling Plans X Engineering Run Activities: 2 Months Execution of up to three (3) Engineering Runs in the GMP suite using Client-supplied Lymphocyte Apheresis (PBMC leukapheresis product) X In process and final product QC testing and data review as agreed upon prior to initiation.
If Company delays the timing for the Engineering Run beyond more than [*] weeks from completion of the last successful Media Fill, Supplier may commence charging the Monthly Fees prior to the Engineering Run.
The stability program for the [****] Engineering Run includes [**] stability pulls over a [********] time period, as set forth in Appendix “C”.
CGMP Runs will be performed in the manufacturing core using the same equipment, facilities and personnel as utilized for the Engineering Run.
X Staging of GMP manufacturing suites & suite activation X Client-specific Master Batch Records X Client-specific Sampling Plans X Engineering Run Activities: 2 Months Execution of one (1) Engineering Run in the GMP suite using Client-supplied K562 Master Cell Bank (MCB).
Mutually agreed Engineering Targets shall be the sole and exclusive basis for alleging any “failure” with respect to an Engineering Run.
By way of example, and not by limitation, COBRA’s obligations to complete the stability program for the [****] Engineering Run ([**] stability pulls over [*** *******]), and AUXILIUM’s obligation to pay COBRA for the stability program for the [****] Engineering Run, shall survive termination or expiration of this Agreement.

More Definitions of Engineering Run

Engineering Run means: the process performed by SYNCO concerning the reintroduction of the manufacturing process of PTH and TEDUGLUTIDE in SYNCO's Facility, which product will be tested to confirm the Reintroduction Objectives can be met.

Engineering Run or “ER” means a Batch manufactured with the purpose of confirming successful transfer and/or implementation of the Manufacturing Process to the Facility.

Engineering Run means each of the first [****(*)] Batches of GTC Product purified and tested by CBSMA pursuant to the terms of this Service Agreement including any Exhibits hereto. The Engineering Runs are not intended for inclusion in the Consistency Series, but after review by GTC of the Batch records and the QC release data, GTC, in its sole discretion, may deem such Batches suitable for use in pre-clinical and clinical applications.

Engineering Run means a cGMP Batch that is intended to demonstrate the reproducible performance of the Manufacturing Process within analytic limits and while performed under cGMP conditions.

Engineering Run means any non-GMP batch run with or without [*].

Engineering Run means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps. “Fujifilm Confidential Information” shall have the meaning set forth in Section 8(b).