Validation and environmental monitoring of aseptic processing. Committee on Microbial Purity.
The many different checkpoints concerning the complementary activities of validation and monitoring of aseptically processed pharmaceutical preparations are described. The features are based on the official and current GMP guidelines. These are outlined in practical terms according to the personal experience of the authors and manufacturing specialists who were consulted.
D004340:Drug Contamination / Q000517:prevention & control*; D004784:Environmental Monitoring / Q000379:methods*; D015203:Reproducibility of Results