Section 96(6) in The Drugs and Cosmetics Rules, 1945
(6)In the case of parenteral and other sterile products filled aseptically, a "Batch Number" shall be assigned to all containers filled from one homogeneous mix during one filling operation, the filling operation being completed in a period of not more than a day and during which no scheduled change in the filling assembly is made.When containers are filled from one homogeneous mix in a number of filling operations, the "Batch Number" assigned to the containers filled in individual filling operations shall be the same "Batch Number" as is assigned to the homogeneous mix, provided the samples taken from all the different filling operations pass the sterility tests, and are kept separate from one another until the report of the sterility test is available.Explanation. - For the purpose of chemical and other tests, representative samples from all containers filled from the homogeneous mix should be taken.
