Canadian perspectives on expectations for process validation.
Ridgway
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A
Biologics & Genetic Therapies Directorate, Health Canada, Ottawa, Ont, Canada. anthony_ridgway@hc-sc.gc.ca
D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000592:standards*; D002170:Canada; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D033161:Government Regulation; D015203:Reproducibility of Results