Pilot Batch definition

Pilot Batch means a Batch of Product designated as a pilot Batch which shall not comply with cGMP and is not required to meet the Specifications.
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Pilot Batch means a Batch of Product designated as a pilot batch which shall not comply with cGMP and is not required to meet the Specifications.
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Pilot Batch means a batch of Product Manufactured during the Development Program at a volume sufficient for process development, stability testing and related quality testing reasonably required by the Development Program, using excipients reasonably anticipated to be clinically safe and made available in containers suitable for the purpose under the Development Program, but which batch does not need to comply with cGMP or cGLP.
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Examples of Pilot Batch in a sentence

  • However, still three GPs of Pilot Batch and 116 GPs of Batch I had not yet completed the project cycle or works were at incomplete stage.

  • Subject to Clause 2, if such tests show that the Product does not comply with the Testing Summary (in respect of product from a Pilot Batch after the Initial Phase) or the Specification (in respect of cGMP Product), Customer shall give Lonza written notice thereof within sixty (60) days from the date of Delivery and shall return such Product to Lonza’s premises for further testing.

  • Any Pilot Batch made after the Initial Phase shall be tested and released against a certificate of testing which will relate to such Testing Summary.

  • Fill out a WCIS Pilot Batch Identification Form (at the end of this section).

  • On success of GPs selected in Pilot Batch and Batch I, GPs in Batch II and Batch III were selected.

  • Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such noncompliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

  • Signed for and on behalf of /s/ Xxxxxx Xxxxxx LONZA SALES XX Xxxxxx Gander Senior Legal Counsel TITLE /s/ Xxxxxxxxx Xxxxxxxxxxx XXXXXXXXX XXXXXXXXXXX KEY ACCOUNT MANAGER TITLE Signed for and on behalf of /s/ Xxxxxx XxXxxxx KOLLTAN PHARMACEUTICALS, INC President & CEO TITLE Dated 30th March 2012 Re: Schedule 2 Stage 10 - Development Pilot Batch (non-cGMP) at [**] Scale Schedule 3 Price and Payment THIS AMENDMENT No. 4 is made the 13th day of December 2013.

  • In the event that Customer provides written notice of cancellation to Lonza at any time of one or more Pilot Batch(es) [***] or less prior to the Commencement Date for such Pilot Batch, then [***] of the Batch Price of each such Pilot Batch cancelled is payable as a Cancellation Fee.

  • Certification Ceremony for INSailors who participated in the Pilot Batch were handed over Skill Certificates and Placement Letters during a valedictory function by the Defence Minister and the Minister for Skill Development & Entrepreneurship respectively on November 18, 2016.

  • Please include a completed WCIS Pilot Batch Identification Form to facilitate identification of your claims.


More Definitions of Pilot Batch

Pilot Batch means the small scale volume of the Product which is produced as a result of the operation of the Process (but not in accordance with cGMP);
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Pilot Batch means first twenty Project Gram Panchayats in which implementation of the Project commenced in April 2001;
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Pilot Batch means a batch of approximately 50,000 doses of a product made on pilot size production equipment at Biovail’s manufacturing facility on which in vitro studies or pilot bio studies may be performed.
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Pilot Batch means a Batch produced from a Run that is completed through the [*] bioreactor, and which is subsequently harvested [*] and purified at the laboratory scale using an appropriate small scale laboratory model of the Manufacturing Process. For a Batch to be considered a Pilot Batch the Batch must be completed [*] and provide sufficient quantities of samples to enable the Parties to complete analytical testing [*]. A Pilot Batch may be processed through the final purification step at the laboratory scale.
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Pilot Batch means a Batch of Product designated as a pilot batch which shall not comply with cGMP.
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Related to Pilot Batch

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Lot or batch number means an identifying number assigned by the enterprise to a designated group of items, usually referred to as either a lot or a batch, all of which were manufactured under identical conditions.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Drop shipment means the sale of a prescription drug to a

  • Recalibration means the adjustment of all DRG weights to reflect changes in relative resource consumption.

  • Pilot or "Payment in Lieu of Tax" shall mean any payment made to the Agency or an affected tax jurisdiction equal to all or a portion of the real property taxes or other taxes which would have been levied by or on behalf of an affected tax jurisdiction with respect to a project but for tax exemption obtained by reason of the involvement of the Agency in such project, but such term shall not include Agency fees.

  • Plasma arc incinerator means any enclosed device using a high intensity electrical discharge or arc as a source of heat followed by an afterburner using controlled flame combustion and which is not listed as an industrial furnace.

  • Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.

  • Marijuana testing facility means an entity licensed to analyze and certify the safety and potency of marijuana.

  • Small quantity generator means a generator who generates less than 1000 kg of hazardous waste in a calendar month.

  • Cannabis testing facility means an entity registered by

  • System Impact Study means an assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights. “System Protection Facilities” shall refer to the equipment required to protect (i) the Transmission System, other delivery systems and/or other generating systems connected to the Transmission System from faults or other electrical disturbance occurring at or on the Customer Facility, and (ii) the Customer Facility from faults or other electrical system disturbance occurring on the Transmission System or on other delivery systems and/or other generating systems to which the Transmission System is directly or indirectly connected. System Protection Facilities shall include such protective and regulating devices as are identified in the Applicable Technical Requirements and Standards or that are required by Applicable Laws and Regulations or other Applicable Standards, or as are otherwise necessary to protect personnel and equipment and to minimize deleterious effects to the Transmission System arising from the Customer Facility.

  • Shift Cycle means the period of time when the shift schedule repeats itself. In those instances where the schedule does not repeat itself, the term "Shift Cycle" shall be understood to mean a period of time not exceeding twelve (12) weeks.

  • Open type traction battery means a type of battery requiring liquid and generating hydrogen gas released to the atmosphere.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Sterilization means the procedure that kills all microorganisms, including their spores.

  • 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.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • 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".