Validation cycle, technology

As we know, a critical step within the development cycle of any new product or process is the scale-up step. At this particular point, it is very important that adequate communications have occurred between the group responsible for the product development and the group charged with process validation. Actually, in many organizations, the process/product development department shoulders the responsibility for product scale-up and then transfers the technology to manufacturing for product commercialization [6],... 

Computer systems validation, as established in 21 CFR Part 211.68, Automatic, Mechanical, and Electronic Equipment, is one of the most important requirements in FDA-regulated operations and an element of the system life cycle (SLC). In addition to the testing of the computer technology, other verifications and inspection activities include code walkthroughs, dynamic analysis and trace analysis. These activities may require 40% of overall project efforts. 

The manufacturing department ships the product in accordance with manufacturing guidelines, based on the receipt of valid purchase orders. The product documentation includes a Declaration of System Validation with statements from Hewlett-Packard that the software was developed and tested according to the Hewlett-Packard Analytical Software Life Cycle, a process that has been certified for ISO 9001 quality standard and for the information technology quality system (ITQS) compliance and that has been inspected by representatives from both computer validation companies and the pharmaceutical industry. 

Alternative cycles are being evaluated for exploratory purposes at Marcoule and Saclay. Laboratory validation trials have been run, in particular on the UTS cycle, which did not match the expectations announced in the literature, the ferrite redox cycle and, above all, the ceria-chloride cycle which, from the initial results, seems to promise good output. It is important to keep an activities of basic researches on these processes because wc arc not sure to be able to pass all the technological blockages on major cycles. 

It is useful to understand the steps of the software development life cycle (SDLC) during a project. In fact, this approach is commonly used for implementation and validation even when commercial off-the-shelf software is involved [104]. It is also important to consider the economic aspects of the automation project [105]. A 10-step guide to success that emphasizes clearly defined project control in outsourced automation/information technology projects has been published [106]. 

Pilot plant development of Triolefin Process technology, requiring about four years, including establishing preferred feed composition, purification techniques, catalyst composition, catalyst activation and regeneration procedures, process conditions, and cycle length. Catalyst life was also determined in repeated cycles and certain design premises (e,g, temperature differential in the reactor) were demonstrated to be valid. 

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