Lab
Tablet friability USP <1216>
In short
USP <1216> friability is the rotating-drum abrasion test for uncoated tablets: a 6.5 g sample tumbles 100 revolutions at 25 rpm and must lose ≤1.0% mass. Friability failure on a supplement compress is the leading indicator of bottle-to-consumer chipping and explains complaint ...
USP <1216> friability is the rotating-drum abrasion test for uncoated tablets: a 6.5 g sample tumbles 100 revolutions at 25 rpm and must lose ≤1.0% mass. Friability failure on a supplement compress is the leading indicator of bottle-to-consumer chipping and explains complaint clusters about 'crumbled tablets' before the customer complaint file fills up.
Regulatory anchors
- USP <1216>
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Software that covers Tablet friability USP <1216>
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