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 whoโve 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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