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Abhishek Singhal
Dr. Garvendra Singh Rathore
Keywords:
Data Integrity (DI), Current Good Manufacturing Practice (cGMP), “G” serves as Good, “x” serves as a placeholder for various regulated domains (e.g., Manufacturing, Laboratory, Clinical) and “P” serves as Practices (GxP)
Abstract:
Data integrity (DI) is a foundational element of Good Manufacturing Practice (GMP), ensuring that all data generated throughout the Pharmaceutical Product Lifecycle are Accurate, Complete, Consistent, and Reliable. Global regulatory bodies—including the US FDA, MHRA, WHO, EMA, and PIC/S—coverge on the principle that trustworthy data are essential for safeguarding Product quality, Patient safety, and Regulatory compliance. The ALCOA+ framework (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) now serves as the universal benchmark for evaluating the credibility and robustness of GxP data across both paper-based and electronic systems.
This paper synthesizes the modern Regulatory landscape (FDA’s DI Q&A(1,2,3) , MHRA GxP DI guide(4), WHO TRS 1033 Annex 4(5), PIC/S PI 041 1(6), EU GMP Annex 11(7), ICH Q9(R1) (8)) and translates it into a practical operating model: risk based data governance, computerized systems validation, audit trail design and review, hybrid controls for paper–electronic environments, and culture. It closes with actionable implementation blueprints, inspection tested controls, and metrics that quality leaders can adopt to reduce DI risk and demonstrate sustainable GMP compliance.
Modern pharmaceutical operations increasingly depend on complex digital ecosystems, requiring comprehensive data governance, validated computerized systems, secure audit trails, controlled user access, and risk-based oversight aligned with ICH Q9(R1). Despite advancements in automation and digitization, recurring inspection findings show that data manipulation, incomplete metadata, uncontrolled spreadsheets, inadequate audit-trail review, and poor documentation practices remain common challenges across the industry.
Moreover, this paper examines the scientific, regulatory, and operational foundations of data integrity, integrating current global expectations with practical implementation strategies. It highlights the need for a sustainable organizational culture that promotes transparency, ethical behavior, technical competence, and continuous improvement. Ultimately, strong data-integrity systems not only ensure compliance but also strengthen scientific decision-making, manufacturing reliability, and the trust that patients and regulators place in pharmaceutical products.
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International Journal of Recent Research and Review
ISSN: 2277-8322
Vol. XIX, Issue 3
September 2026
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PUBLISHED
September 2026
ISSUE
Vol. XIX, Issue 3
SECTION
Articles
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