Batch Production Record definition

Batch Production Record or "BPR" means a record of one or more manufacturing steps of a Batch (e.g. thawing, aseptic filling, inspection, and packaging) and made concurrently with the Manufacture.
Sample 1Sample 2
Batch Production Record. BPR Bulk Drug Substance: BDS Certificate of Analysis: COA *** Confidential material redacted and submitted separately to the Commission Certificate of Compliance: COC Current Good Manufacturing Practices: cGMPs Drug Substance and Drug Product: DSP Non-Conforming Material Reports: NCMR Not More Than: NMT Not Less Than: NLT Quality Assurance: QA Quality Control: QC Standard Operating Procedure: SOP Standard Quality Agreement: SQA International Conference on Harmonization: ICH Active Pharmaceutical Ingredient:rHu PH20
Sample 1
Batch Production Record has the meaning set forth in the Quality Agreement.
Sample 1

Examples of Batch Production Record in a sentence

  • Batch Production Record Review (6.7) Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labeling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed.

  • Batch Production Record & 2nd person for quality control: CCR § 40264 Recommendation: Allow flexible options for licensees to perform the verification.

  • Batch Production Record ReviewIn Part II one section describes the expectations for batchproduction record review (no details in Part I).

  • The individual responsible for preparing the batch specific copy should confirm by signing, the hard copy or by an electronically sign off if a validated computerized system is used, that the correct Master Batch Production Record has been copied/printed, that correct quantities of material and correct batch number and expiration date (if applicable) have been entered and that the copy/printout is completely legible before the Batch Production Record is given to the production department.

  • The processing of each product will be documented on a Batch Production Record.

  • Subpart I--Production and Process Control System: Requirements for the Batch Production Record Sec.

  • A record of the packaging or repackaging of each batch, unless this is included in the Batch Production Record, should be made and include designation of the packaging materials and labels used.

  • The Manager, or designee, of Manufacturing Support Services will perform a final review of the Batch Production Record including manufacturing test results as required.

  • Master Batch Production Record SampleMaster Batch Record Sample Clauses - Law Insider (For full list, see FDA Sec.

  • All shipments will be Ex Works (EXW) (IncoTerms 2010) from the Facility, except that Xxxxxxxxxx will be responsible for packaging the Product as specified in the Batch Production Record, and Dyax shall bear all shipping and insurance charges as set out in the applicable Work Order, which means that (a) Product will be Delivered from the Facility to Dyax's carrier; and (b) risk and title to Product pass to Dyax upon Delivery to the carrier.


More Definitions of Batch Production Record

Batch Production Record means the detailed process steps for the production of the Product, including quality control testing as agreed by AVID and Inhibitex.
Sample 1
Batch Production Record means the set of detailed processing instructions, which are to be followed by Manufacturer to Manufacture one Batch of Product within the meaning of 21 CFR part 211.188, or its successor as in effect from time to time. "Certificate of Analysis" means a certificate, in the form attached hereto as Exhibit B, to accompany each Batch of Product that documents the analytical results, including a detailed report on sterility, endotoxin and appearance for that Batch of Product and confirms compliance of that Batch of Product with the Specifications in accordance with Governmental Approvals.
Sample 1
Batch Production Record or “BPR” shall mean the formal set of instructions for production of Product including the In-Process Specifications, identification of raw materials, master formula, sampling procedures, and critical process-related SOPs for manufacturing intermediates and final Product.
Sample 1
Batch Production Record means a manufacturing record for a Patient Lot generated by MD Xxxxxxxx concurrently with the production of a specific Patient Lot such that successive steps in such processes are documented.
Sample 1

Related to Batch Production Record

  • 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.

  • API means the American Petroleum Institute.

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

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

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

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

  • Manufacturing Process means any process for—

  • 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.

  • 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.

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

  • 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;

  • 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.

  • 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.

  • 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.

  • 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.

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

  • 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.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Study Data shall have the meaning set forth in Section 8.1.

  • DNA sample means any material that has come from a human body and consists of or includes human cells;

  • Cost of materials means the cost of components, parts or materials which are intended for the production, manufacturing or assembling of the goods bid for and which are not produced, manufactured or assembled in the factory where the production, manufacture or assembly of such goods occurs, including freight, landing costs, port charges, import duties and other import costs of such components, parts or materials and all costs in connection with the handling and transport thereof prior to delivery at that factory;