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  • Data Integrity and its Compliance

    In the Pharmaceutical industry, data Integrity plays a pivotal role as it judges the safety and quality of pharmaceutical products. Data Integrity (DI) is very important as it ensures the authenticity of data and information obtained in the production and control of pharmaceutical products.

    Data Integrity and its role

    In Pharmaceutical Industry during recent years the number of observations has increased regarding the integrity of data, documentation, and data management practices during the implementation of good manufacturing practice (GMP), good laboratory practice (GLP), and good clinical practice (GCP).FDA has observed the CGMP violations involving data integrity during CGMP inspections. Data integrity is important for an industry to ensure the safety, and quality of drugs. Data integrity and CGMP nonobservance have led to many regulatory actions, including warning letters, alerts, etc. The data and information should be complete as well frequently referred to as meeting “ALCOA” as; attributable, legible, contemporaneous, original, and accurate. Pharmaceutical companies are following data integrity and increasingly important because the manufacturers will guarantee the purity, and safety of the product, and record and justify any non-compliance.  The effectiveness of the operations depends on the integrity of the data. Data Integrity is very important and is critical to judge the efficiency of manufacturing processes and the quality of products. Data Integrity is very important as different international, regional, and national authorities have already prepared new or revised existing guidelines on this topic. According to FDA, this guide helps to know whether the controls are in place to ensure that data is complete, activities are documented at the time of performance, activities attributable to a specific individual, authorized individuals can make changes to records, is there a record of changes to data, records reviewed for accuracy, completeness, and compliance with established standards, etc. According to WHO while developing medicine and bringing it to market involves a variety and number of activities, like robustness and accuracy of the data to be submitted by manufacturers to regulatory authorities, and the data, must be comprehensive, complete, accurate, and true to assure the quality of studies supporting applications for medicines and it must comply with a number of standards, such as good manufacturing practices (GMP), good clinical practice (GCP) and good laboratory practices (GLP).

    References:

    • https://www.who.int/medicines/news/emp-data-integrity-guide/en/
    • https://www.europeanpharmaceuticalreview.com/article/114804/exploring-data-integrity-guideline-changes-moving-into-2020/
    • https://makromedicine.com/blog/gmp-data-integrity
    • https://www.ympronta.it/en/blog/our-blog-1/post/data-integrity-in-pharmaceutical-industry-2
    • https://www.fda.gov/media/119267/downloadhttps://selvita.com/blog/data-integrity-in-quality-control-laboratory-how-to-ensure-it/
    • https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_819_data_integrity.pdf
    • https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf
    • https://www.who.int/medicines/news/emp-data-integrity-guide/en/

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