Drugmakers should apply a lifecycle approach to process validation — tying together data on product and process development, the commercial manufacturing process and maintenance and consistency of the process during routine commercial production, according to the European Medicines Agency (EMA).
Although companies can choose among a traditional approach, continuous process verification or a combination of the two, the agency appears to favor continuous verification when feasible.
“The in-line, on-line or at-line monitoring that is often utilized for continuous process verification … provides substantially more information and knowledge about the process and might facilitate process improvements. When feed forward or feedback loops are employed, then it is possible to adjust the process during manufacture to maintain finished product quality,” a draft guideline states.
The guideline — posted on the EMA website April 13 — aligns with International Committee on Harmonisation Q8, Q9 and Q10 documents and is intended to validate the production process of planned commercial doses only.
The FDA adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. A pity, then, that most drugmakers didn’t use a lifecycle approach when ICH Q10 made its debut ... and didn’t have a clue as to how to begin.
Many still don’t. But worry not — help is at hand. FDAnews’ A Process Approach to Pharmaceutical Quality Systems: A Guide to ICH Q10 Compliance is an all-new management report that helps you bring your drug manufacturing quality systems into compliance.
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