PJI Biotech 

PJI Biotech

  Strategic Quality and Regulatory Management Consulting

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Data Integrity

Posted on February 7, 2018 at 11:35 AM
Regulators around the globe have issued guidances on data integrity in last five years (1-5). This is not something new. Guidances have been in place since drug development started. However, it has surfaced as a key issue in the last five years during regulatory inspections of raw materials and drug suppliers overseas. In simple terms, data (paper or electronic) should be complete, consistent and accurate throughout the data life cycle, i.e. from raw data generation and recording through use, migration, retention, archival and destruction. It is critical to ensure data integrity because data errors could make an adulterated drug batch reach the patient, thus impacting patient safety. What is the solution? The path forward includes 2 main steps: (A) Conduct a through assessment of current data integrity systems and identify if there are existing issues and remediate those issues. (B) Develop and implement sustainable data integrity systems by training employees and establishing the governance structure to provide oversight for management and continuous improvement of data integrity. (1) Data Integrity and Compliance with cGMP, Guidance for Industry (April 2016) https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf (2) MHRA GMP Data Integrity Definitions and Guidance for Industry (March 2015) https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf (3) WHO: Guidance on Good Data and Record Management Practices (September 2015) http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf (4) PICS: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (August 2016) https://picscheme.org/en/publications. (5) CFDA Drug data management guidance (October 2016).

Categories: Current Regulatory Trends

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