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There was little computerized recordkeeping and even the chromatograms may have been printed on a wax-like paper that faded with time. Many measured peaks with a ruler and calculated relative areas with a hand-held calculator. You were fortunate if you had chromatographic instruments capable of integrating their own peaks and calculating concentrations. You probably performed your final manufacturing, and development studies mostly on the US mainland.Ĭomputerized equipment was available, but in its infancy. If you were part of a US company you generally received your raw materials and packaging components from locations in the US including, of course, Puerto Rico.
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At that time, the world was a bigger place shipping was relatively more expensive, and we relied to a great degree on locally supplied drug products. This might be considered the beginning of modern drug regulation. The authors met for the first time around 1980, shortly after major revisions to the US current good manufacturing practices (CGMPs) had gone into effect in 1978. Regulators are delivering a message that should be clear to all people with good intentions:, that data recorded should reflect all of the things that were done, and all of the rationale used for the decisions made. In its Draft Guidance from August 2016, the Pharmaceutical Inspection Convention and Pharmaceutical (PIC/S) explains that, “Poor data integrity practices and vulnerabilities undermine the quality of records and evidence and may ultimately undermine the quality of medicinal products.” PIC/S also goes on to discuss the impact of open versus closed corporate cultures on data integrity reporting and control.
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In its July 2016 Draft Guidance to Industry, Data Integrity Definitions, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) also refers to ALCOA and defines data integrity as, “The extent to which all data are complete, consistent and accurate throughout the data lifecycle.” Of note, they also explain in the Introduction, that, “Organisations are not expected to implement a forensic approach to data checking on a routine basis, but instead design and operate a fully documented system that provides an acceptable state of control based on the data integrity risk with supporting rationale.” The document goes on to describe the expectation for routine data review within a wider data governance system.
Personal integrity code#
Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate (ALCOA).” The data integrity requirements from Title 21, Code of Federal Regulations for drugs (Part 211) and positron emission tomography drugs (Part 212), are found as follows: the completeness, consistency, and accuracy of data. In its April 2016, Draft Guidance to Industry, Data Integrity and Compliance with CGMP, FDA defined Data Integrity as, “. The root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual. Through the data integrity rules, regulators are trying to assure the integrity of the data in large part by assuring the integrity of the people who make the products. The term data integrity wasn't invented by the regulators, but its language gives regulators the ability to enforce rules.
Personal integrity professional#
How often do such breaches stem from personal integrity issues, when a professional who knows better decides to take a shortcut and fails to see the potential ramifications of an action (or failure to act)? When people act with integrity, the data they generate will usually follow suit.
Personal integrity full#
Over the past few years, the news has been full of reports about data integrity breaches in the bio/pharmaceutical industry.