Increasingly complex supply chains and source globalization in Life Sciences manufacturing has created an environment of uncertainty regarding the quality of incoming materials and the need to monitor these materials more closely. Because vendor-supplied quality checks submitted in the form of C of A always show that the material is within the required specification limits, the goal is to detect when these test results may be faulty, identify unusual and potentially dangerous trends, and reveal when a vendor may have changed their process, source material or manufacturing location. Such due diligence requires constant monitoring and the application of analytics to all appropriate data, yet many Life Sciences companies do not have comprehensive programs for monitoring raw material supplier quality using current-generation analytics and reporting tools. Data Access DeniedWhile it is universal to require that vendors perform quality checks on all materials and to provide Certificates of Analysis, this data is made available in a wide range of non-standard formats (paper, proprietary-format text files, Excel, etc.) and is not often collected in an accessible data system for immediate or long-term analysis. Most life science companies also perform some incoming materials testing, with the test results entered into a LIMS or equivalent system. Not all incoming materials are subjected to comprehensive testing, and the data from tests that are performed are not always subject to routine or real-time analytics. The combination of inaccessible supplier data and incomplete internal test data makes it difficult to routinely check supplier results with internal testing and nearly impossible to perform long-term analysis to detect trends or process changes. Closing these gaps becomes a strategic imperative and several of NWA’s customers sought an assist in improving their Vendor/Raw Materials monitoring programs through the application of analytics. These solutions have ranged from applying analytics and notifications services accessing existing databases to providing methods for collecting and managing vendor-supplied information.For NWA’s customers, initiating a comprehensive Raw Materials data management, analysis and reporting program generally began by taking one or more of the following steps:Step #1 – Collect vendor-supplied test results into an accessible, validated database. This has required a combination of approaches, depending on how vendors provide the data, which is usually in the form of a Certificate of Analysis. Methods include:
- Manual data entry from printed or electronic images of Certificates of Analysis.
- Automated import from electronic submissions via Excel (XLS) and other user-generated files.
- Automated import from function-specific files and file formats such as CSV and XML.
- Configurable Data Entry forms tailored for keying in test results from Certificates of Analysis sent by vendors. The software immediately writes the results to a centralized Quality Information System database hosted on MSSQL Server. The input forms are designed to reduce the chances of keystroke errors and provide immediate feedback when values entered are outside of the expected range. A second set of forms is used to review and approve the data to meet GMP, also flagging data that appears to be outside expected ranges.
- Automatic import of Excel files sent by vendors into product-specific forms that allow manual review prior to moving the data to the same QIS database. This data is also reviewed/approved by another staff member on a second set of forms to meet GMP.
- Connecting “off-line” and “real-time” analytics and reporting applications to the Incoming Raw Materials database to access the results of vendor-supplied raw materials data. Only data approved during the “GMP” step can be accessed.
- Connecting the Analytics and Reporting applications to the LIMS to access the results of in-house testing of the incoming raw materials.
- Creating role-specific analytics reports, real-time dashboards and email/SMS notification to put the right information into the right hands at the right time.
- Avoiding quality issues reported as adverse patient outcomes that could have been prevented by better use of vendor-supplied information and internal testing.
- Reducing the number of in-process, lost-productivity issues caused by changes in raw material quality or composition.
- Increasing finished-product yield by reducing the number of lots rejected for failing to meet specifications.
- Including Raw Materials test results in CAPA program to bring needed improvements to the supply chain.
Published in the June 2013 issue of Pharmaceutical Manufacturing magazine