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 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.

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. ​

Examples of Process Validation Batch in a sentence

• 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.

• 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 [* * *].

• 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.

• 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 [***].

• Lonza may retain and test the samples of such cGMP Batch or Process Validation Batch.

• 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.

More Definitions of Process Validation Batch

Process Validation Batch. “Special Sampling Instructions” mutually agreed to in advance 4.2.11 Customer Lot# and Expiration Date if Applicable 5. Forecast & Planning

Process Validation Batch means a cGMP Batch that is produced with the intent to show reproducibility of the

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. “Product” means the Drug Substance or Drug Product as described in Project Plan to be manufactured by Lonza for Customer as specified in the Project Plan “Project Plan” means a Statement of Work (SOW) or plan(s) describing the Services (as defined below) and Price, including any update and amendment of the Project Plan to which the Parties may agree from time to time in an executed writing. Each Project Plan shall make reference to this Agreement and be governed by the terms hereof, and upon signature by both Parties the Project Plans are each incorporated into and shall be an integral part of this Agreement but separate from any other Project Plans. The initial Project Plan will be attached hereto as Appendix A. “Quality Agreement” means the agreement, that, subject to cGMP requirements, defines, establishes, and documents manufacturing and testing activities and responsibilities of the Parties in relation to quality. Upon signature by both Parties, the Quality Agreement and any amendments thereto are incorporated into and shall be an integral part of this Agreement. “Raw Materials” means all qualified ingredients, solvents, primary packaging materials, filter, single-use liquid- paths and other components of the Product required to perform the Manufacturing Process or Services set forth in the bill of materials. Raw Materials expressly includes Special Material(s), Lonza Procured Materials, and Customer Materials. “Regulatory Approval” means the approval by any Regulatory Authority to market and sell the Products in the respective