Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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10 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Data Integrity D ata supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regula- tory citations for data integrity issues. The acronym ALCOA requires data be attributable, legible, contem- poraneous, original, and accurate. The acronym ALCOA+ adds the concepts that, in addition to ALCOA, data also needs to be complete, consistent, enduring, and available. It is important to understand what each element of ALCOA and ALCOA+ mean in order to apply the concepts appropriately with respect to a company's records. The following are some general definitions, paraphrased from the Pharmaceutical Inspection Co-operation Scheme (PIC/S) (1), that can be used for understanding the elements of ALCOA and ALCOA+: • Attributable: The data generated or collected must be traceable back to the individual who generated the information. • Legible: The data recorded must be readable and permanent. • Contemporaneous: The results, measurements, etc. must be re- corded at the time the work is performed. • Original: Original or source data are the record, report, note- book etc. where the data point was initially recorded. • Accurate: The data recorded must be complete, consistent, truthful, and representative of facts. • Complete: Information that is critical to recreating and under- standing an event. This would include any repeat or reanalysis performed on a laboratory test sample. • Consistent: The data are presented, recorded, dated, or time- stamped in the expected and defined sequence. • Enduring: The data or information must be maintained, intact, and accessible throughout their defined retention period. Susan J. Schniepp is executive vice- president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates. SKÓRZEWIAK - STOCK.ADOBE.COM ALCOA+ and Data Integrity Susan J. Schniepp Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.

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