Detail Design Specifications
Equipment design specifications are provided by the vendor of the equipment. QPS acquires the vendor's specifications, carefully reviews them against the Individual System Specifications and then prepares a Purchasing Document that echoes back to the vendor his own specifications with any modifications or options that the customer requires. Process design specifications (especially as the process may apply to scale up) may be slightly more involved if multiple personnel and equipment integration is a consideration. In the case of process design, prior process development reports must be carefully considered. A decision must be made about the need for additional development work and the cost benefit to be derived prior to finalizing new process designs. QPS will work closely with the customer to assure the best possible solutions to new process implementation. In both cases, equipment and processes, the creation of detail documentation is essential to complying with regulatory requirements for operational control.
Qualification Process Solutions
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©2005 Hurry! and get it right. Narlin Beaty Developments QPS Lyophilization 13406 Bythenia Rd., Phoenix, MD 21131 (410) 683-4834(office)