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.

  • 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.

  • The learned Counsel for the appellant also relied on the decision in Income-tax Officer v.

  • By no later than May 31, 2002, KRWSSA shall engage independent consultants for monitoring quality of construction of schemes for the Pilot Batch, and, thereafter, shall engage independent consultants for each Subsequent Batch prior to the commencement of the construction of schemes for each such Subsequent Batch.

  • Required Delivery Schedule:(a) Before affecting the bulk supply, the supplier shall supply a Pilot Batch of two reams of Pressure Sensitive OBA Free Self Adhesive Sticker Paper within 30 days from the date of award of contract along with laboratory Test report, free of cost, as pre-production sample for trial run on machines at India Security Press, Nashik Road.

  • Understanding its importance, we started Pilot Batch of Welding & Fabrication Skill Development Course under Skill India in association with Montfort Integrated Education Centre commenced on 16th January, 2020.

  • Submit a Pilot Batch Production Notice as prescribed by the GUIDELINES FOR GIVING NOTICE OF PILOT BATCHES OF MEDICINES, where appropriate.

  • The product development process comprises five phases: Feasibility, Functional Prototype, Production Prototype, Pilot Batch (PiBa) and Field Follow-up, and five gates: Master Specification (MS), two Design Reviews (DR’s), Qualification, and Project Closure, see figure 1.

  • Future Work59 List of References 61List of AppendicesAppendix 1 - Feasibility Phase Appendix 2 - Prototype Phase Appendix 3 - Pilot Batch Phase List of FiguresFront figure.


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 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 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 Product manufactured through non-GMP lab scale run, with the purpose of supporting pre-clinical evaluation but not in compliance with cGMP or the Specifications).
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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 have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

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

  • Manufacturing Site means a location where a manufacturing

  • 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 or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • 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: “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. Transmission Facilities:

  • 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 filling with liquid and generating hydrogen gas that is 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 the Generating Facility, after completion of the construction of the Generating Facility, in order to verify that the Generating Facility may be released for Operation.