Getting Started (After the Equipment Specifications) Process validation cannot begin when the first commercial size batch is produced. It must start much earlier. In reality, process validation begins in the…
The Change Control Process10 A typical approach to change control is outlined as follows: 1. A change is thought to be necessary (eg, a line operator thinks that changing a manual…
The Role of Change Control The change control program is the mainstay of maintaining a compliant state of the process or operation. It is used in every aspect of the…
Figure 1.1 Original approach=VALIDATION. Figure 1.2 Current approach=COMPLIANCE. It must be understood that maintaining compliance is a never-ending process. PV is not one step, thus it really isn’t the “last…
