Technology Transfer of Drug Product
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first batch, received from the parent location or FDD of a…
SOP for Control Sample Management
Control Sample is an appropriately identified reserve samples that is representative of each batch, in the same container closer system in which the product is marketed. It may Starting Material,…
Hold Time Study of Cleaned Equipment (CEHT)
Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments needs to be established to ensure that it is capable…