ICH Q10 Guidance and Process Validation Guidance published by FDA in 2011 both emphasizes routine process monitoring and continued process verification (CPV) as an integral part and a third and final stage of process validation and its life-cycle management.
A nice and very detailed case study has been published by BPOG (Biophorum Operations Group) on how to implement CPV. Though this case study is very detailed, here below is summarized in a flow chart the steps involved in setting up CPV. This gives an idea of what procedures, tools and efforts needed to rapidly setup a CPV program at your organization.
For definitions of CPP, KPP and MP refer to our July 27, 2015 blog on SPC.
Steps 1 through 4 involves scientific judgement hence cannot be automated. This will involve some initial lag time to establish a CPV program. However an efficient knowledge management platform can greatly help in rapidly identifying parameters to monitor and establishing trending techniques and can significantly help in reducing time of deployment.
Steps 5 through 11 require fair amount of labor and can become a daunting task to routinely monitor hundreds of parameters (especially for complex biologic products), investigate trends and keep updating/adjusting the control limits to keep a check on process variability and capability. Adding to this if your site/organization is a multi product commercial manufacturing site this activity become impossible to perform manually and keep up the frequent reviews of processes with limited resources (FTE's) available. Most of the steps from Steps 5 through 11 can easily be automated and a specially designed software tool for CPV purpose can prove to be great advantage having capabilities in terms of:
A nice and very detailed case study has been published by BPOG (Biophorum Operations Group) on how to implement CPV. Though this case study is very detailed, here below is summarized in a flow chart the steps involved in setting up CPV. This gives an idea of what procedures, tools and efforts needed to rapidly setup a CPV program at your organization.
For definitions of CPP, KPP and MP refer to our July 27, 2015 blog on SPC.
Steps 1 through 4 involves scientific judgement hence cannot be automated. This will involve some initial lag time to establish a CPV program. However an efficient knowledge management platform can greatly help in rapidly identifying parameters to monitor and establishing trending techniques and can significantly help in reducing time of deployment.
Steps 5 through 11 require fair amount of labor and can become a daunting task to routinely monitor hundreds of parameters (especially for complex biologic products), investigate trends and keep updating/adjusting the control limits to keep a check on process variability and capability. Adding to this if your site/organization is a multi product commercial manufacturing site this activity become impossible to perform manually and keep up the frequent reviews of processes with limited resources (FTE's) available. Most of the steps from Steps 5 through 11 can easily be automated and a specially designed software tool for CPV purpose can prove to be great advantage having capabilities in terms of:
- data integration and warehousing of all relevant historical process information
- lot traceability and genealogy
- performing correlations across process steps for quick troubleshooting
- overlaying batch trends
- templating specific process parameters for routine periodic trending
- historical limits management
- validated reporting
Few tools in this space have emerged recently (in last few years) catering to process data management and particularly CPV.
Our ProcessPad platform is industry first completely web-based bioprocess data management software for rapidly deploying CPV in your organization. Contact us for more information at info@simplyfeye.com.
More about us at: http://www.simplyfeye.com
