If a reconstitution of the product is needed the instructions provided with the product should be followed. In the case of liquid formulations the volume packaged should be measured with appropriate precision and accuracy. critical steps should be controlled in-process by appropriately qualified and trained staff.sorting the containers per subject number) once the packaging has been completed for all products to be packaged for a given trial and the products have been released, the packaged test and reference products can be taken simultaneously into the packaging area for further operations (e.g.If packaging is performed for several trials successively line clearance should be ensured between each product and each trial the working area should be cleared of all IMP, packaging material and documents between the packaging operations of the test and of the reference product (line clearance).reconciliation should be performed for the quantities of IMP units, containers and labels introduced in the working area, used during the packaging and remaining after these operations, before the area is cleared and before the packaged IMPs are released.Material used for different products should not be available in the packaging area simultaneously during these operations not only should the test and reference products be kept separate, but also all material used for the packaging of each product (containers, labels) and the batch record documents.the test and the reference product should be packaged during separate operations and should not be available simultaneously in the packaging area.The packaging should be performed in such a way as to limit the risk of possible mix-up between the test and reference product. (GMP guidelines, ยง4.18: Before any packaging operation begins, there should be recorded checks that the equipment and work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use).
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