ISPE celebrates the 1st birthday of the FDA’s Data Integrity and Compliance Guidance

The International Society for Pharmaceutical Engineering, ISPE, will host their last San Francisco/Bay Area Chapter Program Event of 2019 at OSIsoft Headquarters in San Leandro, California on December 12th from 5:30 pm - 8:30 pm. The central topic of the event will be around Data Integrity in the Life Sciences Industry, and the timing of the event is notable.

December 12th, 2019, marks the 1st birthday of  when the American Food and Drug Administration (FDA) issued their final guidance on data integrity, related to current Good Manufacturing Practice (cGMP) for drugs, including biologics, as required in CFR parts 210, 211, and 212.  

The guidance was originally drafted and initiated in response to an increased number of FDA warning letters citing inadequate data integrity within the Pharmaceutical and Biotech Industry.  The number has increased in recent years, from 10 citations in 2014 to 42 in 2018 - especially in China, U.S., and India at pharmaceutical companies, manufacturing operations, clinical trials, and quality units of varying sizes.

The FDA enforces Data Integrity, but what does it really mean in the Life Sciences Industry? The FDA refers to data integrity as; “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).

alcoa definition

  • Attributable - Traceable to a unique individual
  • Legible - Data must be recorded permanently and be readable
  • Contemporaneous - Activities must be recorded at the time they occur
  • Original or a true copy - first capture of data (not transcribed data), must review the original record, must retain the original or certified copy of the original record. If copy is complete it contains all metadata.
  • Accurate - records must be accurate, which is achieved thru the Quality Management System

All data generated becomes part of the GMP record and must be recorded and saved at the time of data capture to be compliant with FDA 21 CFR requirements pertaining to pharmaceuticals and biologics. For example; The person(s) entering data into the record must be unique and identifiable, or attributable, through their login in accordance with CGMP requirements in parts 21 CFR 211 and 212. Shared, read-only user accounts that do not allow the user to modify data or settings are acceptable for viewing data, but each user that has the ability add or edit data must have a unique log in.

The good news for pharmaceutical manufacturers is that improving data integrity isn't just a way to stay on the right side of the law. Better data means better research, better decision making, smoother plant operations, faster time to approval, and ultimately better, safer, and faster drug development - all helping to ensure patient safety.

Petter Moree, Global Industry Principal at OSIsoft, Craig Taylor, Associate Director, Manufacturing and Lab Systems at BioMarin Pharmaceutical Inc., Bruce Watts, Sr. Engineering Project Manager at Allergan, and Conn McLean - Engineering Director, DST Controls, will cover use-cases from leading pharmaceutical companies and their journey to becoming data-centric and data-driven.

Sign-up for the ISPE here: https://ispe.org/san-francisco-chapter/events/data-integrity-life-sciences-industry

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