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 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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Process Validation Batch or “Process Performance Qualification Batch” or “PPQ Batch” means a Batch of Product produced from a process validation run conducted by SBL 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.

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

  • Manufacturing Process means any process for—

  • 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.

  • Batch Record means the production record pertaining to a Batch.

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

  • 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.

  • 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.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;