Batch Packet definition

Batch Packet means a compilation of records identified in the Quality Agreement for a Batch, including but not limited to, [**].
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Batch Packet means a compilation of records, including but not limited to, executed process records, genealogy, certificate of analysis (“COA”) and associated Quality Control data, [*] Deviation Reports, Disposition of Product form, Restriction Summary and Facility Assessment memo.
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Batch Packet means the package of relevant documentation, including, but not limited to, production records, in-process and release testing, and QA lot release documents, to be transferred to Sponsor in relation to a Drug Substance Batch as detailed in Attachment A to the Quality Agreement.
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Examples of Batch Packet in a sentence

  • The warranties set forth in this Section (i) survive acceptance of the Product or Manufacturing Services by Customer (including any Batch Packet acceptance); and (ii) are for the sole benefit of Customer.

  • Agilent will subsequently provide Customer a complete Batch Packet (in electronic PDF format).

  • Agilent shall not ship Product hereunder unless and until: (i) Agilent has provided to Customer the Batch Packet for such Product and under the condition that all opened deviations, investigations or other anomalous events related to such Batch have been resolved, and (ii) Customer has reviewed the Batch Packet for such shipment and authorized such shipment in writing.

  • Agilent shall maintain records, including Master Batch Records and Batch Production Records, with respect to the manufacturing and quality testing of the Product and shall deliver the Executed Batch Record (in electronic PDF format) to Customer prior to Agilent providing the complete Batch Packet to Customer.

  • Upon receipt of a complete copy of the Batch Packet, Customer will use commercially reasonable efforts to review such Batch Packet, and advise Agilent of any deficiencies or corrections needed within [**] business days (“Target Review Period”).

  • In addition, Agilent will provide to Customer the completed, executed batch records for each manufacturing step as such step is completed and approved by Agilent’s Manufacturing and Quality groups, on a rolling basis (and in any event, within [**] days of the completion of the manufacturing step) in order to expedite completion of the final Batch Packet review.

  • Upon Customer’s request, during the Target Review Period [**] Agilent will make available for up to [**] business days the necessary personnel for in-person, on-site meetings at the Facility (or such other location as the Parties may agree) to facilitate Customer review of the Batch Packet.

  • Following Agilent’s resolution (to Customer’s satisfaction) of any issues raised by Customer’s review of the Batch Packet, Agilent shall ship the Batch of Product.

  • Copies of all analytical QC raw data (including chromatograms) and reports generated by Agilent will be provided to Ophthotech with the Batch Packet for in-process and final API analysis following manufacture.

  • You may now proceed to the Models for Screening-Level Exposure Estimates component of E-FAST V2.0.3.0 MODELS FOR SCREENING-LEVEL EXPOSURE ESTIMATES‌‌ After you have selected the Chemical ID for the chemical of interest, you can click on “Models for Screening-Level Exposure Estimates.” The Screening Level Main page will appear (see Figure 3-1).


More Definitions of Batch Packet

Batch Packet has the meaning set forth in the Quality Agreement.
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Batch Packet means [* * *].
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Batch Packet means the package of relevant documentation to be transferred to Sponsor in relation to a cGMP Batch as detailed in the Quality Agreement or Scope.
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Related to Batch Packet

  • 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.

  • Batch Record means the production record pertaining to a Batch.

  • API means the American Petroleum Institute.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Data Package has the meaning set forth in Section 2.9(a).

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • 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.

  • Batch number means a unique numeric or alphanumeric identifier assigned prior to any testing to allow for inventory tracking and traceability.

  • 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.

  • Module means specific portion of the Application Software designated as such in the Documentation made available to the Customer under the Notification Form.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Sample means urine, blood, breath, saliva, or hair.

  • QA means Quality Assurance.

  • Exit Package means a sealed, child-resistant certified receptacle into which marijuana items already within a container are placed at the point of sale.

  • Certificate of Analysis means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Manufacturing Process means any process for—

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;