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1.6.1
brunnerbalazs
Nov 13, 20232 min read
Periodic reviews - what to use them for?
PQR, QMR, CPV, VMP/VMR, Computerized systems' periodic reviews, who knows what else...we manufacture these summaries, but exactly what...
10 views0 comments
brunnerbalazs
Nov 10, 20233 min read
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...
23 views1 comment
brunnerbalazs
Jul 1, 20233 min read
Training and regulatory requirements
Let's collect all requirements on training from GMP. EU GMP Volume 4 Chapter 2 Section 2: Training '2.10 The manufacturer should provide...
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