Test-data transmission from producer

Automation of Test-Data Transmission from Producer to Computer Master File... 

When more than one plastic resin is used to fabricate bottles, it is necessary to demonstrate the equivalency of the container produced using the different resins. In addition, comparative data derived from light transmission, chemical resistance, extractables, and moisture permeation/vapor transmission tests described in the USP should be provided as applicable to the type of product. (For example, moisture permeation for an aqueous dosage form would not be necessary). Whereas the compendia discuss these tests only in the context of polyethylene, the guideline makes no distinction as to the resin used. It also should be verified that copies of letters authorizing FDA reference to appropriate DMFs from manufacturers of the resins used to fabricate bottles and from the bottle fabricator s), if available, are included. Although most resin suppliers include information on extractables data in their DMFs, it should be pointed out that fabricators may have to add release agents or other additives not covered by extractables data in the DMF of the resin supplier. 

The methods described above were tested at two sites in Hawaii The Nuuanu reservoir on Oahu, which is above downtown Honolulu, and the Waikoloa Dam on Hawaii Island, which is above the town of Waimea. In both cases the analyses were performed with and without topographic data obtained by a field survey crew. Detailed results from the ca e studies and results of a sensitivity analysis are reported elsewhere. The flood inundation maps produced for Waimea and Honolulu were overlaid onto several GIS infrastructure layers. These layers included major roads, secondary roads, schools, nursing homes, hospitals, police stations, fire stations, civil defense headquarters, chemical plants, electric plants and transmission lines, water plants, and wells (which could be contaminated by floodwaters). Critical facilities in the flood zone were identified and listed along with their mailing addresses and phone numbers of contact personnel. 

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