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.
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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. 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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Examples of Batch Production Record in a sentence

  • All shipments will be Ex Works (EXW) (IncoTerms 2010) from the Facility, except that ▇▇▇▇▇▇▇▇▇▇ 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.

  • For added clarity, in-process Product Specifications/requirements are documented within the Batch Production Record and final Product Specifications/requirements are documented within Material Specifications.

  • If any Deliverable is considered Non-Conforming Product, MD ▇▇▇▇▇▇▇▇ shall, as promptly as reasonably possible, either: (a) remake or produce a new Deliverable, or (b) to the extent it is legally permitted and also reasonably practicable, rework or Reprocess the Patient Lot, so that the Patient Lot or Deliverable (x) can be deemed to have been Manufactured in compliance with cGMP and the agreed Batch Production Record, as applicable, and (y) conforms to the Specifications.

  • At the completion of all work for each lot, CBL will provide Client with a copy of the completed Batch Production Record including a Certificate of Analysis.

  • All shipments will be Ex Works (EXW) (IncoTerms 2010) from the Facility, except that ▇▇▇▇ 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 of loss to Product shall pass to Dyax upon Delivery to the carrier.

  • APC will develop the Batch Production Record and In-Process Testing prior to the initiation of the production of Product intended for use in clinical trials.

  • Any deviation from the process during Production, including but not limited to, Batch Production Record execution, environmental monitoring excursions or processing procedures, will be carefully explained and documented in an investigation and referenced in the Batch Production Record per PYRAMID procedures.

  • CONFIDENTIAL TREATMENT REQUESTED (g) “Batch Record” (also referred to as Manufacturing Batch Record (MBR) or Batch Production Record (BPR) means a manufacturing record for a Batch generated by Gallus concurrently with the performance of each step of the production of a specific Batch or Lot of material such that successive steps in such processes may be traced.

  • The amount of retained samples shall be specified by MAP and provided to EDDI and shall be recorded on the Batch Production Record.

  • APC shall immediately and no later than two (2) business days notify Revance of any material deviations from the Batch Production Record or any Failed Lot, manufacturing, supply or delivery issues or other information of which APC becomes aware which may affect the ability of APC to supply Product in accordance with this Agreement, the production timeline or the applicable Purchase Order.


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 a manufacturing record for a Patient Lot generated by MD ▇▇▇▇▇▇▇▇ 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 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 has the meaning set forth in the Quality Agreement.
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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. 1.8 "Business Day" means a day that is not a Saturday, Sunday or a day on which banking institutions in Boston, Massachusetts, USA or in Laupheim, Germany are authorized by law to remain closed. 1.9 "Cell Line" means the clonal cell line that has been designed and engineered to produce the corresponding recombinant protein product shown in Appendix A, particulars of which are set out in Work Orders 1.10 "Certificate of Analysis" or "COA" means a summary of testing results on samples of products or materials together with the evaluation for compliance to a stated Specification by a Qualified Person. 1.11 "Certificate of Conformity" or "COC" means a document issued by ▇▇▇▇▇▇▇▇▇▇ attesting that a cGMP Product Batch has been manufactured in compliance with cGMP's and that Production Batch Records have been reviewed and approved by ▇▇▇▇▇▇▇▇▇▇ QA Management. 1.12 "cGMP" or "Good Manufacturing Practices" means current good manufacturing practices as defined in the German Regulation for Manufacturing of Medicinal Products and Active Ingredients, General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 2003/94//EC and ICH Guidance Q7A (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. 1.13 "cGMP Product" means Product which is required under Work Orders to be manufactured in accordance with cGMP. 1.14 "Commercially Reasonable Efforts" means, with respect to the activities under this Agreement, the efforts and resources used by a reputable biopharmaceutical contract development and manufacturing organization for drug substances and drug products of similar nature, complexity and developmental stage. 1.15 "Conforming Batch" means a Batch which both Dyax's and ▇▇▇▇▇▇▇▇▇▇'▇ quality assurance groups have determined to have met the following requirements: (i) has been produced in accordance with cGMP; 2 / 2 Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.
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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.