Exploring the Data Integrity Ordinance in Pharmaceutical Domain

    Published on:September 2022
    Journal of Young Pharmacists, 2022; 14(4):xx-xx
    Review Article | doi:

    Darshil B Shah1,*, Jignesh S Shah2, Dilip G Maheshwari1

    1Department of Quality Assurance, L J Institute of Pharmacy, LJ University, Ahmedabad, Gujarat, INDIA.

    2Department of Regulatory Affairs L J Institute of Pharmacy, LJ University, Ahmedabad, Gujarat, INDIA.


    With the revolutionary expedition of technologies being used in pharmaceutical world to collect and process data, the honesty of data is predominant factor and subject to preservation. If the data collection of the products soon to be marketed, is adulterated it would not only be a potential harm to general public but also cause of economical and reputational damage for manufacturers. To secure the value of crucial data, regulatory authorities has been producing guidance regarding the integrity of data. Data integrity guarantees that data is not tampered with be it paper or electronic. Protecting the integrity, whether electronic or handwritten, is essential for making sound business decisions. In attempt of introducing aspects of data, the FDA first developed the ALCOA principles which are still the first line defence of integrity breaches in pharmaceutical companies. With the changing times of technologies, FDA evolved the data integrity principles into requirements and specifications of current good manufacturing practice answering questions directly from manufacturers. To understand the basic yet complex terms and conditions, this article strives to outline the Data Integrity requirements of USFDA specified in its cGMP guidance for data integrity specifications.

    Keywords: Pharmaceutical Data Integrity, ALCOA, U.S. Food and Drug Administration (FDA).