Process Validation Batch definition

Process Validation Batch means a Batch that is produced with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies.
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Process Validation Batch means a Batch that is produced according to Master Batch Record and approved validation protocol(s) with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies.
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Process Validation Batch means a Batch of Commercial Product produced from a process validation run conducted by SBL hereunder to (i) demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, and (ii) support the Regulatory Approval of both the Product Manufactured and the Manufacturing Process at the Facility each as defined in the Project Plan.
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Examples of Process Validation Batch in a sentence

  • In the event there is a failure of an Engineering Batch, the parties will agree on whether another Engineering Batch is necessary or whether the next run should be a Process Validation Batch.

  • If during the period starting from the date of completion of Manufacture of the last Process Validation Batch until the end of the Term, Client decides or is required to withdraw from all markets in the world for any scientific, medical or efficacy reasons, Client may terminate the applicable PSA for the Product upon one and a half (1.5) year prior written notice to SBL, subject to Section 15.3 below.

  • All ordered Batches shall be scheduled in a single Campaign in each [***], excluding the first [***] ([***]) [***] after the Lonza Release of the last Process Validation Batch (forecast for the [***] of the last batches of commercial campaigns may be up to [***] ([***]) [***] apart during this period), unless otherwise agreed by Lonza.

  • The Service Fees for any Batches including but not limited to Engineering Batch, Process Validation Batch, PAI Batch, Batches for Commercial Products shall be invoiced [* * *].

  • Upon cancellation of any Batch or termination of the Agreement, all unused Raw Materials which cannot be used by Lonza for the manufacture of other products for other customers shall be paid for by Customer within [***] ([***]) days of invoice and at Customer’s option and cost will either be (a) held by Lonza for future use for the production of Product for up to [***] of the last Process Validation Batch and (b) [***] ([***]) months thereafter, (b) delivered to Customer, or (c) disposed of [***].


More Definitions of Process Validation Batch

Process Validation Batch means a Batch of Commercial Product produced from a process validation (process performance qualification, or PPQ) run conducted by SBL hereunder to (i) demonstrate and document the consistency and reproducibility of the Manufacturing Process at the Facility, and (ii) support the Regulatory Approval of both the Product Manufactured and the Manufacturing Process at the Facility.
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Process Validation Batch. “Special Sampling Instructions” mutually agreed to in advance 4.2.11 Customer Lot# and Expiration Date if Applicable 5. Forecast & Planning
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Process Validation Batch means a cGMP Batch that is produced with the intent to show reproducibility of the
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Related to Process Validation 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.

  • 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.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • 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.

  • Process weight means the total weight of all materials introduced into any source operation. Solid fuels charged will be considered as part of the process weight, but liquid and gaseous fuels and combustion air will not.

  • Non-Conforming Product means a Product that does not conform to the Supplier’s Warranties.

  • Process Wastewater means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product, or waste product.

  • Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Procurement Process means the process commenced by the issuing of this Invitation and concluding upon the award of a contract (or other outcome as determined by Tetra Tech International Development) or upon the earlier termination of the process

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • Backflow prevention device means a safety device used to prevent pollution or contamination of the water supply due to the reverse flow of water from the irrigation system.

  • Acceptance Testing mean the tests, reviews and other activities that are performed by or on behalf of Agency to determine whether the Deliverables meet the Acceptance Criteria or otherwise satisfy the Agency, as determined by the Agency in its sole discretion.

  • 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.

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

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