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Showing posts from July, 2018

GOOD MANUFACTURING PRACTICE: WATER FOR PHARM PRODUCTION

WATER FOR PHARMACEUTICAL PRODUCTION Water is the one of the major commodities used by pharmaceutical industries. It may be present as an excipient, or used for reconstitution of products, during synthesis, during production of finished product, or as a cleaning agent for rinsing vessels, equipment and primary packing materials etc. There are many different grades of water used for pharmaceutical purposes. Several are described in USP monographs that specify uses, acceptable methods of preparation, and quality attributes. These waters can be divided into two general types: bulk waters, which are typically produced on site where they are used; and packaged waters, which are produced, packaged, and sterilized to preserve microbial quality throughout their packaged shelf life. There are several specialized types of packaged waters, differing in their designated applications, packaging limitations, and other quality attributes. Different grades of water quality are required dependin...