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MA974 (Evaluation (According to spec, Tables, Final reports, Specific…
MA974
Evaluation
According to spec
Tables
Final reports
Specific requests
Sample disposal
Sample preparation procedure
Requirements de preparação
Package configuration
Storage Conditions
II+IVa+Acc? só?
Sample Quantity
Qtd para 3x o teste
Testing Frequency
Number of timepoint + tests
Stability Specification
Tests and specs
Justification on SITs
Changes, degradation, etc.
Stability testing
Sample analysis requirements
Opening, Use
Results
OOS
OOT
Number of samples to prepare
Packaging