Data Integrity breach: A critical challenge faced by the pharmaceutical industry throughout the regulatory audit

Manufacturing of pharmaceutical products consists of multiple steps and the generation of several data connected to the different manufacturing processes. All the data that is generated as a result of product manufacturing should be accurate and reliable. Because it will directly relate to the quality of the pharmaceutical product. it is the basic necessity of any pharmaceutical industry to produce such a product that is reliable for its quality throughout the entire life cycle of the product. currently, There is various regulatory guidelines are available for data integrity maintenance starting from the first guideline given by USFDA in 1963. Various leading regulatory authorities like the US FDA, WHO, MHRA, EMA, and PIC/S have already given their standard for data management and data integrity. In the last few years during the inspection by regulatory bodies in different pharmaceutical industries, various breaches in data integrity due to a deficiency in good manufacturing practice (GMP) have been observed, leading to non-compliance with the guidelines set up by the regulatory body. During the regulatory inspection if this type of non-compliance is observed then it will lead to a diminishing effect on the pharmaceutical industry in way of getting a warning letter and issuance of form 483. Further, it leads to safety concerns, product withdrawal from the market, a ban on importation, business damage, and sometimes closure of the pharmaceutical firm. This review article focuses on the concept and importance of data integrity in the pharmaceutical industry, possible ways to minimize data integrity, and improvement in compliance with regulatory requirements.