Posted: September 13th, 2017

Control Systems & Real-Time Analytics

Paper, Order, or Assignment Requirements

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