Regulating Quality in Continuous Processing

Regardless of the industry and product being manufactured, continuous processing has demonstrated numerous benefits. In addition to smaller manufacturing footprints, reduced material consumption and waste generation, increased efficiencies, and lower capital and operating costs continuous manufacturing typically leads to more consistent processes and product quality. In the pharmaceutical industry, the latter two attributes align perfectly with FDA’s Quality by Design (QbD) and process analytical technology (PAT) initiatives. The challenge is determining how to apply these concepts in practice.

Applying the Idea of a Batch/Lot to Continuous Processes
Because the pharmaceutical industry has traditionally used batch-based manufacturing processes, regulatory requirements pertain to batches or lots, as outlined in the various regulations and guidance documents from agencies around the world such as those in ICH Q7, 21 CFR 210, Health Canada’s GMP guidelines (GUI-0001), and EMA MEDDEV 2.5/6 Rev. 1.

In general, a batch (or lot) is considered to be a specific quantity of material produced in a process that is expected to be homogenous and meet certain specifications. For a continuous process, therefore, a batch can be considered to be a defined fraction of the production run that is homogeneous (is typically produced on the same day by the same person with the same equipment, is tested in the same way, and meets specifications).

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