Document for pharma companies, contract manufacturers and laboratories focuses on data governance and data integrity
GMP Audit Manual - Data Governance and Data Integrity is the latest release by the Data Integrity Working Group at Rx-360, the International Pharmaceutical Supply Chain Consortium.
The document provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories for data integrity and data governance elements.
The scope includes the manufacture and testing of human and veterinary medicinal products regulated by FDA, intermediates, active pharmaceutical ingredients (APIs), excipients and raw materials critical to product quality.
Designed with GMP auditors in mind, the manual is also targeted to stakeholders including those who have limited experience with data governance and data integrity expectations and enforcement practices.
The audit manual is to be used in conjunction with the ISPE GAMP Records and Data Integrity Guide.
The ISPE Guide provides the framework and context for the content of the audit manual. The audit manual, however, is not intended to ‘teach’ data integrity or data governance concepts.
A broad discussion of computer system classification, validation and controls may be found in the ISPE publication: GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems (2008).
The document is available to download from the Rx-360 website.