Keys to Manufacturing Data Integrity

Data integrity is a crucial issue for both the laboratory and the manufacturing floor of a GMP pharmaceutical manufacturing facility. The Parenteral Drug Association’s (PDA’s) Data Integrity Task Force aims to help industry members understand how to maintain data integrity. PDA published Elements of a Code of Conduct for Data Integrity in 2016, which is available for industry members to download from the PDA website, along with other resources. Pharmaceutical Technology spoke with Els Poff, executive director of Merck & Co.’s Data Integrity Center of Excellence and member of PDA’s Data Integrity Task Force, about data integrity and PDA’s efforts to educate the industry. Poff is currently leading the development of a PDA technical report about data integrity in manufacturing, and as part of Pharmaceutical Technology’s Keynote Series at INTERPHEX, she will present “Regulatory Requirements for Data Integrity, Applying ALCOA+” on April 18, 2018 at 11 am on the Innovation Stage.

PharmTech: The need for data integrity in the pharmaceutical laboratory seems clear, but what are the reasons that manufacturing floor personnel must also make data integrity a priority? 

Poff (PDA): Data integrity is the process of maintenance and assurance of accuracy and consistency of GMP data over its entire lifecycle, which includes data generated in the manufacturing/production areas. Recent citations from [FDA] warning letters include data integrity observations directly related to shop floor systems and processes, such as sharing of username and password, batch records with blanks (not filled in), data in batch records not directly recorded at the time it was generated, and audit trial function not enabled.  Although health authorities focused heavily on the lab systems initially, we do see a shift toward the more holistic expectation to have accurate and complete records, and that includes manufacturing records. 

PharmTech: What are the most important things to understand about data integrity in pharmaceutical manufacturing? 

Poff (PDA): The reliability of production and control data is dependent on the procedures, systems, processes, and controls that are in place to ensure data integrity. The integrity of production data starts from the point of data creation, and it continues throughout the entire data lifecycle including storage and the ability to retrieve the data at a later point in time to support the quality of the products manufactured. Pharmaceutical manufacturers need to ensure that relevant data are available to document what actually occurred, the data are attributable to the persons who entered the data, and that the data cannot be altered, deleted, omitted, or in any way modified to misrepresent what actually occurred. Data integrity is the cornerstone of establishing and maintaining confidence in the reliability of data to ensure product quality and patient safety.  

PharmTech: Who/what is the PDA Data Integrity Task Force? What are their current projects and future plans? 

Poff (PDA):The PDA Data Integrity Task Force consists of members from generic [-drug], biotech, large pharma, and consulting firms, plus staff and liaisons to the PDA Regulatory and Quality Advisory Board. Its objective is to define the strategy to deliver data integrity solutions to the pharmaceutical industry and regulatory under the leadership of the PDA, by providing training, publishing technical reports and papers, and organizing conferences and workshops.

Projects are currently underway to identify data integrity best practices for the laboratory, on the manufacturing shop floor, and for quality systems, in the form of technical reports. Future plans are to continue to foster dialogue between health authorities and industry members to raise awareness and to reach alignment on expectations around data integrity.