The issue of pharmaceutical data integrity is more important than it has ever been. Data is both the backbone of CGMP compliance and the fuel of the digital economy. Secondly, global regulatory bodies have become increasingly focused on data integrity and have issued many actions of varying severity.
The following collection of resources are the leading guidances and resources for pharmaceutical data integrity.
FDA Draft Guidance: Data Integrity and Compliance With CGMP Guidance for Industry
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography Drugs. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. Access Guidance
MHRA GxP Data Integrity Definitions and Guidance for Industry
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) guidance on data integrity is one of the globe’s leading resources on the topic. Access Guidance
Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry
The Parenteral Drug Association’s (PDA) Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry outlines key elements necessary to help ensure the reliability and integrity of information and data throughout all aspects of a product’s lifecycle. It is intended to be used in whole or in part to guide a company’s internal practices, create or modify an existing data integrity code of conduct, or in developing agreements with outsourcing partners or other suppliers. The elements identified throughout this document are intended to reinforce a culture of quality and trust within the pharmaceutical industry. Access Data Integrity Code of Conduct
Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) – Good data management practices influence the integrity of all data generated and recorded by a manufacturer and these practices should ensure that data is accurate, complete and reliable. While the main focus of this document is in relation to data integrity expectations, the principles herein should also beconsidered in the wider context of good data management. Access PIC/S Guidance
Library of Data Quality, Records Management & FDA Recordkeeping Laws
Be compliant with US regulations and statutes on data integrity and recordkeeping in order to avoid stiff penalties and preserve corporate value. This robust collection of resources will prove to be quite helpful. Access Library
