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
Gate 2: Stakeholder Review
Gate 3: Transfer Plan
Today, I will be discussing Gate 4: Transfer Process Map.
Most process maps are a single page, high level view of the process to be transferred. The benefit of a high level view is to provide a simple, visual overview for people outside the transfer working group. However, it is important to note that this visual does not necessarily facilitate the communication needed for a successful transfer. I like to think of it like the map of the United States that you might find on the wall in elementary school. It provided the boundaries and major features, but would not be very helpful to get from New York to Los Angeles.
A transfer process map is a highly detailed map listing all transferred process steps with inputs and outputs. The steps to create this map are outlined below:
1) A draft transfer process map is populated with steps from the sending site Master Batch Record (MBR) and associated operational Standard Operating Procedures (SOPs). The draft transfer process map creates a framework for a facilitated process review.
2) Next, facilitated process review meetings with Subject Matter Experts (SME), associated functions and quality assurance are designed to review each step of the process. The goal of the facilitated meetings is to ensure steps and requirements do not “appear” and “disappear”, as well as ensuring that requirements for steps are known. The requirements for each step should include identifying Critical Process Parameters (CPP) to ensure that the final product meets specification.
3) A receiving site transfer process map is then completed with the associated receiving site SME’s, associated functions and quality assurance. Steps that are different (i.e. double batch size, equipment classification change) are highlighted in red and provided to regulatory affairs for filing strategy.
4) A modified risk assessment is conducted and relevant equivalency studies are planned to ensure that CPPs changes do not affect the finished product.
5) The agreed transfer process map can then be used to develop a receiving site MBR, SOP’s, job descriptions, raw material specifications and related GMP documentation.
The next step in the series is Gate 5: GMP Documentation.
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