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.
This publication provides guidance and acceptable practices for the medical gas industry to comply with data integrity. It identifies the acquisition and retention of data obtained to assure it is complete, consistent, accurate, attributable, contemporaneously recorded, and auditable regardless of the form in which it is obtained and maintained.
This publication does not address what data is acquired during the manufacturing and testing of medical gases.