WBF and OMAC are bringing standards to a line near you

A drug maker’s ability to qualify new equipment could be significantly reduced if committee work now being carried out by the World Batch Forum and the OMAC Packaging Workgroup comes to fruition.

Representatives from OMAC Packaging Workgroup and WBF’s S-88 Part 5 committee have been comparing notes by telephone ever since a May 19 meeting in Lincolnshire, IL. At the Lincolnshire meeting, the groups decided they needed to work more closely together to achieve mutually desirable goals in the areas of automation, integration, and manufacturing excellence in general. The next face-to-face meeting of this newly formed consortium will occur sometime in August, say those who are active in the group. The exact date and venue are still being finalized.

An immediate goal for the group is to harmonize the work already done by each. Agreeing on standardized modes and states is a key objective. Should such an agreement be reached, pharma manufactureres might be able to buy off-the-shelf software from OEMs. That will greatly reduce time spent qualifying custom programming, which should lead to a streamlined FDA validation process.

It will also be simpler to connect equipment on a packaging line to a Manufacturing Execution System or Enterprise Resource Planning (ERP) system. Without standardized modes and states, plant-floor connection to an MES or ERP system requires custom code or extensive configurations. That takes time.

Those interested in participating in the WBF/OMAC Packaging Workgroup project should contact l@lcraig.com.

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