Batch Production Record definition

Batch Production Record or "BPR" means a record of one or more manufacturing steps of a Batch (e.g. thawing, subcultivation, fermentation, capture, chromatography, aliquoting, packaging) according to the EU GMP Guidelines Part II, Section 6, Subsection 6.5 in German language, based on the MPR and made concurrently with the Manufacture.
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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.
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Batch Production Record has the meaning set forth in the Quality Agreement.
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Examples of Batch Production Record in a sentence

  • 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.

  • Those with a steady or temporary contract are more often full-time cyclists than temporary personnel from another company.

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

  • 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.

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

  • 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.

  • A discussion was had about closing the gate to Stage Road, which is currently closed during the cookoff with only a string of pennants.

  • 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.

  • Preparation of Batch Manufacturing Record (BMR ...Master Batch Production Record Sample 1.

  • Batch Production Record (BPR)Batch manufacturing record of Rifampicin Batch No XX was reviewed.


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.
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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.
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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.
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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
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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 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.

  • 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.

  • 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.

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with 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.

  • 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.