_x000D_
Consider the system block diagram below. This block diagram represents three steps of_x000D_
a manual process for mixing various dry raw materials and packaging these materials_x000D_
for sale and distribution. Just considering the three steps below and the control systems_x000D_
automation lifecycle as outlined GAMP conduct the following exercises;_x000D_
1. Provide a diagram showing the basic steps required to automate this process_x000D_
a. Raw materials are added manually into separate compartments in the first_x000D_
step_x000D_
b. No manual intervention is allowed until the packaged material comes out_x000D_
of the third step_x000D_
2. For each of the 3 steps identify a maximum of 2 CPPs and 2CQAs_x000D_
3. If this was for a pharmaceutical product and assuming this is a critical GAMP_x000D_
category 4 (software) automated solution, provide a flow chart of the documents_x000D_
required to bring the automated system into operation._x000D_
4. Provide a high-level architecture showing the proposed automated system and_x000D_
how this will integrate to an architecture with the following systems highlighted_x000D_
a. Historian_x000D_
b. Batch system_x000D_
c. Reporting system_x000D_
d. MES system_x000D_
5. For one of the CQAs identified in item 2 above, suggest a mechanism for_x000D_
measuring and controlling this attribute._x000D_
Dispensing_x000D_
Blending /_x000D_
Mixing_x000D_
Packaging_x000D_
_x000D_
_x000D_
_x000D_
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