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carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level, which is below predetermined levels [15] The reasons behind the validation of cleaning procedures are the assurance of the safety and purity of the product (customer requirement), it is a regulatory requirement in active pharmaceutical ingredient product manufacture, and it assures the quality of the process from an internal control and compliance point of view [15] Cleaning should be carried out with relative ease and with the use of standard cleaning materials [7] Vacuum facilities should be available for cleaning and contact parts fouls be wiped down and sanitized utilizing a sanitizing agent The equipment should be washed, dried, covered, and stored in an equipment storage area As in manufacturing, the packaging operation starts with the generation of the packaging order.

This consists of the approved packaging components, the batch number of the product to be packaged, and quantities of each A supervisor veri es the accuracy and completeness of the packaging order, including expiration date, line being used, and any other special equipment being used for that operation These steps are accomplished prior to bringing components to the line The complete line area, including all equipment, is veri ed as being properly disassembled and cleaned of all product and components from the previous packaging operation After the QA department has veri ed that the area has been cleared and cleaned, the components must be brought to the line for mechanical setup Once the setup mechanic has completed all the adjustments required, a supervisor oversees the prestart procedure.

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This consists of cleaning all products used during the setup; counting labels used in the label setup; rechecking all components and lot numbers; verifying the bottle count, all stamps, and lot numbers; and signing the packaging order that all is in readiness to start packaging operations Nonappropriate cleaning procedures will develop batches of poor quality due to the risk of presence of a number of contaminants, such as precursors of the drug, degradation products, solvents and other materials employed during the manufacturing process, microorganisms, cleaning agents, and lubricants [15]..

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are occupied, subsequent users would need to wait until another user logged out of the program, thus releasing the license Users could be prevented from loading a program from a server if the network or the server is being heavily worked Once the program is downloaded to the local PC, there is no further network interaction required until the application is released by the user This interaction was called the le services portion of the NOS Print services were also an important piece of NOS Printer requests would be queued to the print server servicing that portion of the network A print server could ACRONYM ALERT have one or many printers under its conFIFO First in, rst out trol As print job requests arrived at the print server, it would determine the printer the print job was to be outputted to.

The print server queued the print jobs on a rst-come, rst-served basis Print jobs were stored on the print server and parceled out to the printer as fast as the printer was able to take the data Today s network-ready printers are basically their own print server with the intelligence and storage capacity required to queue print jobs from a large user base There were many networking operating systems, but the most popular were Novell NetWare and Microsoft Networking Novell utilized an IPX/SPX protocol stack to provide communications over its network Both Novell and Microsoft have since migrated to supporting the TCP/IP protocol suite over their networks TCP/IP is not a NOS; it is a protocol that controls communications between peers A client/server application can be run over a network that uses TCP/IP protocol for communicating over the network, but the actual client/server application is independent on the protocol itself.

The majority of today s networks are TCP/IP-based networks that have a wide range of applications running over them A workstation may have multiple sessions to various servers on the network simultaneously Most people use e-mail and may be logged into a corporate mail server while running other applications to other servers over the same network The need for a network server running a NOS is not required when running the TCP/IP protocol over a network..

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