Process development phase

Epperly, W. R. (Project Director). "EDS Coal Liquefaction Process Development—Phase IV", Annual Tech. Rept. for July 1978-June 1979 from Exxon Research and Engineering Company to U.S. Department of Energy and Electric Power Research Institute under Contract No. EF-77-A-01-2893, September 1979. 

A validated manufacturing process is one which has been proved to do what it purports or is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment, systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. 

CMP waste quality during the manufacturing process development phase is highly variable owing to continued experimentation and R D activities. 

In large-scale syntheses, the minimum amount of solvent is added at each step and the amount is adjusted at each cycle as the swollen volume of the peptidyl resin increases. These amounts are previously determined on a smaller scale during the process development phase of the project. There is also the possibility that during the process development phase, it becomes apparent that the most economical method of synthesizing large amounts of the peptide is by a combination of solution and solid-phase methodst or completely by solution chemistry.t ... 

PAT is different from traditional analytical chemistry in that the goal is to characterize a material undergoing a transformation and to measure the progress of the transformation. An additional difference is that, in modern PAT, the composition of the material is known. The exception is when real-time analysis is used in R D in the discovery phase, where unexpected reaction routes may occur, or in the process development phase, where unexpected by-products may form. 

Save time overall, both within the medicinal chemistry and process development phases of a project... 

---