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www.biopharminternational.com Emerging Therapies 2022 eBook BioPharm International ® 15 multiple sponsors all with var ying protocols and documentation requirements. The inconsistencies across organizations can lead to documentation errors due to unfamiliarity. Some of these errors can lead to a manufacturing hold, such as: • a mismatch of information (i.e., volume on a certificate of analysis does not match the volume on the product label) • incomplete or missing information or data • information that is not legible • test results that are out of client specifications • any issue with the COI. These types of issues must be corrected to avoid manufact uring delays. A rea l-time raw materia l documentation and labeling review is intended to catch these types of errors prior to product release from the collection site. A real-time post-apheresis review process Researchers tested a real-time post-apheresis raw ma- terial documentation and labeling review system in January 2018. An organization that became opera- tional in 2016 had gained visibility within a year of its launch because of its documentation collection pro- cess across centers that were collecting allogeneic raw material. Researchers at the organization conducted a retrospective review in December 2017 of six months'- worth of collection documentation, which revealed er- rors in the documentation that accompanied the raw materials that were delivered to the manufacturer. Based on the documentation errors found in this review, a pilot program was launched in January 2018 to establish a real-time, pre-release review of collec- tion documents. The goal of the pilot program was to enhance collection-site support and reduce docu- mentation errors. After six months, the program realized a 60% re- duction in documentation quality incidents (1). This success, along with the evaluation of product labels, led to the inclusion of the product label in the re- al-time, pre-release review. Documents typically reviewed in real-time included: • certification of analysis • certificate of compliance, per regulatory authority • review of health history screening questionnaires and record of physical exam • Information Standard for Blood and Transplant (ISBT) 128 label • biohazard tag(s), as applicable • donor test results (e.g., complete blood count [CBC] with differential) • product test results (e.g., CBC with differential, flow cytometry, etc.) • institutional collection procedure records. Over the next year, documentation errors contin- ued to decline. January 2018 and June 2019 demon- strated a 90% reduction in documentation and label- ing quality incidents (1). In June 2019, the real-time review moved from a collection net work suppor t team within the organization doing the review to that organization's quality control (QC) unit, and the reduction in documentation and labeling quality in- cidents continues to be maintained. This error reduction has been maintained even as more collection facilities began providing raw mate- rial at increasing volumes for multiple protocols. While this collection volume increase led to more errors being identified, the review process resulted in a significant decrease in documentation errors that got carried over to the manufacturer and which could lead to a hold. In addition, the organization found that individual sites are conducting a more robust review and verifi- cation process prior to sending documents for the re- al-time review. Therefore, errors are being identified and corrected earlier in the supply process, leading to greater efficiencies and fewer delays in the packaging and release of the product. The reviews have also allowed for the identification of common errors across sites. As a result, the organiza- tion has been able to make improvements in training, document design, and documentation instructions. These results all demonstrate the critical value of a real-time, post-apheresis review. Steps to a real-time review The real-time review process begins after the product has been collected and any processing steps are com- plete. Once the site has completed all its required doc- umentation and labeling, it submits a scanned copy of the required documents and product labels (including aliquots or product parts) via secure email to the orga- nization conducting the real-time review. The QC unit of that organization communicates to the site that the documents have been received and the review has started. If there are no errors, the QC unit sends an email with the approval to release the product to the manufacturer. If errors are detected, the site receives communication identifying the errors. The site then corrects the errors and resubmits the documents or labels for review. The The industry must take steps to improve documentation integrity and standardize. Manufacturing