Operating Procedures (SOPs) Preparation
Standard Operating Procedures (SOPs) Preparation In the preparation of SOPs there are often higher levels of documents that control the functionality of the various systems and operations. At a corporate…
Started (After the Equipment Specifications)
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…
Change Control Process
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…
Role of Change Control
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…
Process Validation (PV)
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…
