Matrix Stability Systems
Managing pharmaceutical stability testing can be very demanding, especially on small to medium size companies developing and producing OTC, generics and new Rx products.
Some companies outsource the actual inventory management and testing requirements, but are still required to track progress and report results as part of their QA or development process. Ensuring that approved protocols are followed precisely, with “pulls” made on schedule and the appropriate tests completed, is a time consuming and tedious task.
Some Stability Managers and Supervisors use Excel™ spreadsheets to store and track this work, but this approach lacks the necessary security and audit trail to comply with FDA regulations, including 21 CFR Part 11. Furthermore, as the information is contained in individual spreadsheets, reporting on complete studies and batches is difficult, requiring that compilations be done manually.
The Matrix Stability Data Management System has been designed in cooperation with several pharmaceutical companies to manage and report on protocol driven studies with associated batches, conditions, pull points, tests and test limits. This powerful system is designed for use with Matrix Plus LIMS or a LIMS from another supplier, providing the best solution to larger companies that also have or want LIMS. However, some companies do not wish to implement a full scale LIMS, but rather require a “stand-alone” stability system. Matrix Stability Express TK has been developed as the total answer to these needs.
Both Matrix Stability Data Management and Stability Express TK contain the following features:
- Protocol Manager used to create and maintain the details of conditions, pull periods and the tests to perform.
- Study Maintenance Manager holds general information about the study, including description, cost center and products.
- Batch Maintenance Manager holds blend, formulation/recipe, packaging and manufacturing details.
- Location Manager contains storage conditions and locations for each container which can be specified by room, rack, shelf, box and more.
- Inventory Manager calculates the total number or amount of samples required for each study, before it is initiated. Retained samples and those required by the protocol are handled separately.
- Reports - many standard reports are included that may be used as designed or modified via Crystal Reports.
- Statistical Analysis - efficient data export to JMP for statistical evaluation of shelf life or retest period.
The Matrix Stability Data Management System is completely configurable via the Matrix Configuration Tools. The information stored concerning studies, batches, conditions, etc may be changed to match your protocols and procedures. When samples are “pulled” they are registered directly into the LIMS database for tracking and testing in the analytical laboratory.