Process Validation Batch or PPQ Batch definition

Process Validation Batch or PPQ Batch means a Batch that is produced in compliance with cGMP with the intent to show reproducibility of the Manufacturing Process and is required to complete process validation studies.

Related to Process Validation Batch or PPQ 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.

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

  • 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.

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

  • 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.