Monitoring
A monitoring plan must be drawn up in writing and implemented which includes in particular the control of critical points in the production process.
The plan includes all planned measurements, analyses and observations of fea-tures which indicate that the critical control points are controlled and applies to pro-cessed materials up to and including the produced feed (end products).
The monitoring plan must at least be in accordance with the inspections estab-lished in this GMP+ FSA module (GMP+ BA4 Minimum Requirements for Sampling and Analysis). The participant must provide the reasoning for the structure of the monitoring plan.