Visualizing the Golden Batch with S88

ISA-S88 is a standard for batch control that many proponents of Quality by Design are adopting. S88 is a design philosophy for processes and recipes (see here for Wikipedia’s pretty good summary) that is becoming more and more relevant in the pharmaceutical industry.

One S88 believer is Centocor’s Paul McKenzie, formerly of Bristol-Myers Squibb. McKenzie, who spoke at the Bioprocess International Conference last fall, explains the value of S88 as follows (as related by Agnes Shanley, who was in attendance):

Each process will have its own raw materials, quantities, process parameters, recipe procedures, and equipment requirements. . . . With a portable recipe, equipment is separated out as its own class, and you assign an equipment class to each area, a good approach for when a process is changing, McKenzie said.

The approach allows users to create a series of recipes. Everyone collects data in the same way, he explained, so that tech transfer becomes ownership of that recipe. As it moves along, you have a master recipe and then a control recipe specific to each actual unit you run. . . .

This in turn facilitates a QbD approach.

“I don’t want people innovating on what they call something in a MS word doc,” McKenzie said, but in terms of parameters, using a common global language to describe process and product.” With this approach, one recipe can be used across the world and global facilities, he said. The method makes it easy to link to regulatory filings and to visualize the “golden batch.”

For the full summary of McKenzie's talk, see "Paul McKenzie's Recipe for Success with QbD".