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:
Gate 1: AssessmentGate 2: Stakeholder Review
Gate 3: The Transfer Plan
Gate 4: The Transfer Process Map
Gate 5: GMP Documentation
Gate 6: Formulation and Process Development
Gate 7: Ready for cGMP Validation
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.