Batch of samples definition
Batch of samples means a group of samples collected during one discrete sampling event and stored and transported in a single shipping container, regardless of the number of samples in the group.
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.
API means American Petroleum Institute.
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.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.