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.
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.
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.

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);
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.
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.
Pilot Batch means first twenty Project Gram Panchayats in which implementation of the Project commenced in April 2001;
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).
Pilot Batch means a Batch of Product designated as a pilot batch which shall not comply with cGMP.

Related to Pilot Batch

  • 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.

  • 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.

  • 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.

  • 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.

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