Guideline for Complying with Data Integrity Regulatory Expectations
standard by Compressed Gas Association, 08/24/2021
Both the U.S. Food and Drug Administration (FDA) and Health Canada (HC) have developed guidance documents for their respective current expectations for data integrity to comply with respective Current Good Manufacturing Practices (CGMP) requirements. In the United States, see Data Integrity and Compliance with CGMP Guidance for Industry and in Canada, see Health Canada Guidance Document GUI-0001, Good manufacturing practices guide for drug products.
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- 1 file , 390 KB
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