Statistical Process Control (SPC) and Continuous Process Verification (CPV)

Simplyfeye team is recently involved in a major project with a multinational pharma company where we are helping the company setup a process monitoring program of all its commercial manufacturing processes using our product ProcessPad.

We all know SPC is an important ingredient of CPV and a process control chart (as shown below) forms the central piece of the puzzle for SPC and any process monitoring program.

Figure 1: Process Control Chart

Here is how we help setup a Process Monitoring program.

Step 1: What to SPC?

Figure 2: Selecting parameters for routine monitoring

Step 2: What limits to apply?

Figure 3: Controlling the process within limits

Step 3: How to estimate control limits?

Figure 4: Statistical rules to estimate control limits

Step 4: How to identify a trend?

Step 5: How it all ends up in ProcessPad?

Figure 5: Outcome of Steps 1 through 4 in real life

Step 5 above shows how ProcessPad platform provides a tool set for rapidly deploying a process monitoring program for your continuous process verification efforts that can be easily validated in GMP environments with minimal efforts.

For more information contact us at: info@simplyfeye.com

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