PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity Inspections

摘要

The Parenteral Drug Association (PDA) has identified 11 current questions related to data management and control that have been frequently cited in U.S. Food and Drug Administration (FDA) inspections or have led to FDA regulatory actions. The purpose of this document is to help to clarify some of these issues for industry and to help facilitate better compliance by sharing PDA members' expertise in and understanding of current best practices. Data integrity inspectional observations by health authorities can have a severe impact on a firm from a regulatory and public perception perspective and should not result from a lack of clarity by industry about what is required. In addition, firms are concerned that the inability to produce a requested record or document during an inspection, even if not a standard report or existing quality system document, could be construed as delaying, denying, limiting, or refusing inspection, which also has significant consequences. The PDA acknowledges it may not be possible for a single firm or site to have a meaningful discussion of these issues in the context of an inspection or inspection response and is offering these best practices so that industry can proactively comply and properly prioritize its efforts to improve document management and control and good manufacturing practices in the most efficient and effective means possible. The PDA acknowledges there are many more questions to be addressed and hopes that there can be an ongoing dialogue between industry and regulators to facilitate answers.