Production Batch Records definition

Production Batch Records means complete, accurate, and fully executed Master Batch Records used in the Manufacture of a batch of API.
Sample 1
Production Batch Records means an accurate reproduction of the approved MASTER BATCH RECORD that includes complete information relating to the production and control of each lot/batch and is fully executed and approved.
Sample 1

Examples of Production Batch Records in a sentence

  • During the term of this Agreement and for a period of five (5) years following the Batch Release Date for each Batch, Duramed shall notify Warner, in writing, within one (1) business day in the event Duramed discovers or has reason to believe there are any cGMP violations by Duramed or any vendor that might have impacted the Product, which violations may be reportable to the Regulatory Authorities or if there are any defects in the Production Batch Records or the Batch.

  • Product retention records and production records, including Master Batch Records and Production Batch Records, for Products produced by the Manufacturer will be maintained by the Manufacturer.

  • The project managers will be responsible for coordinating the work effort, liaising with necessary internal staff and resolving any issues that may arise.

  • The Production Batch Records and Goods Intake records are retained and filed by Technical for every day’s production and can be retrieved for traceability purposes.

  • Production Batch Records shall include the theoretical and actual yields of major steps in the processing.

  • After initial discussions with the supplier it was agreed that it would be practical to trace Production Batch Records from the Butchery and Fish departments for each day w/c 13th Jan.

  • Notwithstanding the foregoing, Navidea Confidential Information shall include the Process, all Master Batch Records, and all Production Batch Records related to the manufacture and release of the Product.

  • Customer will further have the right to inspect (or, if requested by the Manufacturer, to have an independent auditor inspect) such books and records of the Manufacturer as are necessary to determine the Manufacturer’s compliance with the terms and conditions of this Agreement, including without limitation the Production Batch Records.

Related to Production Batch Records

  • Batch Record means the production record pertaining to a 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.

  • 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.

  • 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • API means the American Petroleum Institute.

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

  • Manufacturing Process means any process for—

  • 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.

  • 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.

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

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • Production Environment means a logical group of virtual or physical computers comprised within the Cloud Environment to which the Customer will be provided with access and use the purchased Cloud Application(s) in production and for its generally marketed purpose.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • SOPs has the meaning set forth in Section 5.7(b).

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

  • Quality Agreement has the meaning set forth in Section 9.6.

  • QA means Quality Assurance.

  • 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;

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

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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 thereof.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

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