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

March 5, 2014

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: Stakeholder Review
Gate 3: The Transfer Plan
Gate 4: The Transfer Process Map
Gate 5: GMP Documentation
Gate 6: Formulation and Process Development

Let’s discuss Gate 7: Ready for cGMP Validation. Lessons learned during transfer batches are not relevant unless the actionable items are implemented and documented with input from Regulatory, Quality Assurance, and applicable support departments. Batch assessment data is included in the transfer report. Many facilities utilize the CAPA (corrective action, preventative action) system to document and assess changes, but the CAPA system may not be robust enough for a transfer assessment depending on the nature of the transfer. Assessments of how to implement corrective action should be agreed with the same team that developed the original process as detailed in the transfer plan (see Gate 3). Additionally the results should match the transfer site. Some facilities place transfer batches in accelerated stability conditions for three months prior to proceeding to validation to confirm validation batches perform the same on stability as filed batches.

A document list is generated throughout the previous gates include a listing of all documents and respective author needed for each of the submission countries, and development reports have been approved to demonstrate the approach is sound. Adjustments to batch records and other GMP (Good Manufacturing Practice) documents need to include a revision history either in the document or as part of the transfer report. The revision history needs to include the justification for changes. Teams should be aware that changes may result in a change to the filing classification.

A budget review is required to ensure not only are transfer costs in line with plans, but also the final production costs are aligned with expectations. Often, transfer batches identify process gaps requiring additional resource allocations that were not planned for. An understanding of how this change affects not only a single product but all transfer and current products.

The regulatory filing strategy developed for the product transfer as part of the transfer plan needs to be assessed. The changes need to be visualized with a revised process map. A filing review meeting with Regulatory, Quality Assurance and Subject Matter Experts presenting the revised process helps to communicate the changes. All changes are to be taken into consideration by Regulatory and discussion on the filing strategy needs to be reviewed by upper management.

The transfer cannot proceed to the next gate until all of the transfer requirements are met and documented in an approved transfer report. Once this is complete, you are able to move on to Gate 8: Process Validation.

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