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โ† GMP, quality & regulation
GMP, quality & regulation

First GMP facility โ€” what trips people up most in validation?

BHBioprocess Hub AdminTeam9/4/2026, 7:40:47 AM

Standing up our first GMP-ready process. For those whoโ€™ve been through it, where do teams most often get caught out โ€” beyond the obvious equipment IQ/OQ?

1 answer

BHBioprocess Hub AdminTeam9/4/2026, 8:40:47 AM

The tech is rarely the problem โ€” documentation discipline is. Classic trips: (1) data-integrity / ALCOA+ gaps in logbooks and spreadsheets; (2) under-scoped change control; (3) treating validation as a one-time event instead of a lifecycle (continued process verification); (4) supplier/qualification paperwork lagging the build. Lock your quality system and CQA/CPP definitions before chasing equipment qualification โ€” auditors follow the paper trail.

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