This data integrity audit manual 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. The target audience for the audit manual is GMP auditors and 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 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).