Life cycle assessment diagram

System failure, probability of, 13 167 System flow diagram, in life cycle assessment, 14 811-813 Systemic infections, sulfonamides for, 23 498-499... 

Figure 13.7 Block flow diagram of current polyfmethyl methacrylate) (PMMA) monomer recycling process. MIB, Methyl isobutyrate MA, methyl acrylate MMA dimer, 1,4-cyclohexane dicarboxylic acid dimethyl ester [87]. Modified from Kikuchi Y, Hirao M, Sugiyama H, Papadokonstantakis S, Hungerbuehler K, Ookubo T, et al. Design of recycling system for poly(methyl methacrylate) (PMMA). Part 2 process hazards and material flow analysis. Int J Life Cycle Assess 20i4 i9(2) 307—19.

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

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