Section 96(5) in The Drugs and Cosmetics Rules, 1945
(5)In the case of containers of parenteral preparations filled from one homogeneous bulk solution and sterilized in more than one sterilizer load, the "Batch Number" assigned to the containers in the different sterilizer load shall be the same "Batch Number" as is assigned to the homogeneous bulk solution, provided the samples taken from all the sterilizer loads pass the sterility test, 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 bulk solution should be taken.
