Data Integrity Resources for Pharmaceutical Manufacturing
A data integrity program is a significant component of a company's Quality System, providing foundational assurance that the data used to demonstrate a company's products are safe and effective for their intended use are in compliance with regulatory requirements. A data integrity program recognizes the company's responsibility to prove the origin, transmission and content of the company's data are what they are purported to be.
Data integrity has been and currently is a major global concern of Health Authorities and the pharmaceutical industry. Although not a new issue, numerous recent Health Authority enforcement actions, such as Warning Letters, Import Alerts, Product Detentions and suspension or revocation of Marketing Authorizations, have focused attention on data integrity.
To provide resources that holistically address issues related to data integrity, PDA is developing a comprehensive set of tools for industry that includes a Code of Conduct, Technical Reports and Points to Consider documents, along with educational Workshops.
The planned suite of resources is outlined below. Through the development and dissemination of these tools, PDA intends to:
- Promote harmonized standards for compliance with regulatory expectations for maintaining data integrity
- Define mechanisms for detecting non-compliance and outline a clear methodology for remediating gaps
- Serve both industry and regulators by creating and defining solutions for the increasing number of failed inspections where firms lack not only the necessary controls to ensure data integrity but also the expertise to detect and resolve non-compliance
- Develop a methodology for restoring confidence in a system and organization to avoid revenue loss and regulatory impacts
PDA Data Integrity Deliverables
2016 PDA Data Integrity Workshops
These Workshops, offered four times in four locations around the world in 2016, include a blend of presentations from regulatory and industry experts, case studies and round table discussions. Special focus will be placed on exploring the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements to provide attendees with a broad perspective on cause and effect and common factors involved in data integrity issues.
Attendees will learn about best practices for preventing, detecting, mitigating and remediating data integrity issues and will have ample opportunity to network with industry peers, regulators and solution providers to enhance the overall learning experience.
Publications Elements of a Code of Conduct for Data Integrity in Pharmaceutical Manufacturing
The Elements of a Code of Conduct for Data Integrity were developed by a team with expertise in the fields of quality, regulatory affairs, auditing and manufacturing and reviewed by attorneys specializing in food, drug and labor law.
Designed to encourage widespread implementation, this document is written for easy adoption, in part or in its entirety, by companies, if they so choose, without the need for extensive rewriting of the document. Therefore, the terms ‘shall' and ‘must' have been used to permit the Code to be enforceable by those companies that choose to adopt it.
Download Code of Conduct
This document is intended to reinforce a culture of quality and trust within the pharmaceutical industry. It is not intended to be a regulatory standard or guidance, nor is it intended to supersede any country-specific or local laws and regulations governing labor, privacy and/or employee rights. The Elements of a Code of Conduct for Data Integrity in Pharmaceutical Manufacturing is available for FREE download to the pharmaceutical industry for internal use. The selling of any portion of this Code is not permitted.
PDA/DHI Book: Assuring Data Integrity for Life Sciences
This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.
Each chapter is written by renowned, highly experience subject matter experts in the fields of compliance and data integrity, and includes a "how to" section with practical, implementable advice. Content is up to date with the latest regulations and guidances, making this the most relevant reference source of its kind. Useful checklists and aide memoirs can be customized by the discerning reader. This book should be equally useful for the quality unit professional, operations manager, validation experts and regulators.
The modular structure allows readers to pick chapters of special interest without having to reach the chapters in order. However, given the usefulness and universal application the "nuggets of wisdom" and advice provided, it is anticipated that readers will want to read the publication in its entirety.
Technical Report Series
PDA's Technical Report (TR) series on data integrity is intended to provide a roadmap for the creation and integration of a Data Integrity Management System as a core element of the QMS. Each TR in the series is intended to focus on a specific element of the QMS and to provide a detailed strategy and framework for establishment of controls and processes necessary to ensure data integrity within that area.
PDA Technical Report: Data Integrity in Laboratory Systems Coming Soon!
The first TR in the series will focus on data integrity within the laboratory system, including raw materials, in-process and finished product release testing within analytical and microbiology laboratories for all phases of the drug product lifecycle. The report will provide the framework and tools necessary to establish a robust Data Integrity Management System, defining key terms and providing methodologies for the acceleration of compliance and remediation strategies for both paper and electronic data. It will also give concrete examples from recent regulatory actions to use in assessing laboratory systems for compliance.
PDA Points to Consider: Fundamental Concepts for Data Integrity
This document provides a brief overview of the key concepts needed in a program to ensure the integrity of GxP data in pharmaceutical manufacturing operations. It explains fundamental concepts for data integrity prevention, detection and response and defines basic concepts, including ALCOA.