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1.6.1
Retest period or shelf-life?
I just received a question that looked easy at first, but the laws and guidelines are surprisingly vague on this topic. The question is:...
brunnerbalazs
Nov 12, 20232 min read
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API reprocess and rework - how can we save a batch?
When an API batch is OOS, several processes get initiated in parallel. We need to exclude the possibility of any lab errors (OK, this is...
brunnerbalazs
Nov 10, 20233 min read
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