brunnerbalazsNov 13, 20232 min readPeriodic 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...
brunnerbalazsNov 10, 20233 min readAPI 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...
brunnerbalazsJul 1, 20233 min readTraining and regulatory requirementsLet's collect all requirements on training from GMP. EU GMP Volume 4 Chapter 2 Section 2: Training '2.10 The manufacturer should provide...