Process Validation: Gate Eight of the Nine Gate Transfer Process

April 2, 2014

Ullustration showing transparent panels in a workflow

Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here:

All systems need to be ready before validation batches can be produced. Systems checklist, agreement on acceptance criteria and commercialization, stability plan, agreement on annual revalidation and approval of the transfer report must be complete to move to the Process Validation.

A systems checklist with quality assurance approval provides necessary documentation that was gathered in the transfer. This should include vendor audits, cleaning validation (residual solvents), Melamine requirements addressed, equipment qualification completed with operational ranges. BSE/TSE addressed, specifications and SOP’s approved. Once raw materials and packaging components are released, the transfer final report is approved. With batch records approved, risk analysis complete, and stability protocol approved, Trackwise systems are set up. Documented evidence of all required systems is placed in a file. This file is then reviewed by QA prior to signature of the Validation protocol.

The decision to commercialize validation batches is made by senior leadership based on a modified risk assessment. Included in the commercialization risk assessment are a review of the product trending report, a review of the process gap assessment and discussions with regulatory. The commercialization strategy also needs to meet the January 2011 FDA guidance for product commercialization.

The stability protocol includes stability requirements for each of the countries the product will be marketed. This may require rental of stability chambers or space in stability chambers for years as the diverse stability requirements are reviewed. The stability protocol may also include expectations for product stability results in relation to commercialization. Looking ahead, planning needs to include agreement on annual revalidation and filing activities.

Execution of the validation plan needs to follow the agreed plan. Typically a daily update meeting will be held to provide updates from the previous day’s activities and ensure all systems are a go for the daily activities. The validation team needs to act accordingly when issues occur. All deviations from the plan must be clearly identified and tracked for root cause analysis. System controls are intended to cover normal operations, external events need to be handled with facility policies and be included in the validation final report.

Next, you will be able to complete the process with Gate Nine: Post-Validation.


Learn more about ProPharma's Technology Transfer services. Contact us to get in touch with our subject matter experts for a customized Technology Transfer presentation.

TAGS:

January 2, 2014

The Transfer Process Map: Gate Four in the Nine Gate Transfer Process for Moving Production

If you have been following along, you now know that I have reviewed the first three gates to the Nine Gate Transfer Process for moving production from site to site. I have covered: Gate 1: Assessment...

March 5, 2014

Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process

Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...

January 24, 2014

GMP Documentation: Gate Five of the Nine Gate Transfer Process for Moving Production

Today we’re back with the next step in the Nine Gate Transfer Process for Moving Production from site to sitea>. So far we’ve covered the first four gates, which you can review in our last blog post....