Over the past 15 years, the FDA (Food and Drug Administration) and EMA (European Medicines Agency) have tasked the pharmaceutical industry to review its development and manufacturing processes to implement a QbD (Quality-by-Design) approach to the product life cycle of pharmaceuticals.

The objective is ensuring medicine quality by utilizing analytical, statistical, and risk-management methodology in the manufacture of medicines. Thus, more consistent, higher quality, and safer drugs will be developed and manufactured.

As set forth by 21 CFR parts 210, 211, and 212, drug manufacturers are encouraged to effectively manage data integrity risks as determined by the understanding of their processes and management of business models and technologies.

The laboratory environment of today is data-intensive with high throughput. To follow QbD principles, data integrity and completeness must support QA/QC (Quality Assurance/Quality Control) operations. Implementing an intelligent informatics infrastructure will ease this task.

A digital infrastructure revolving around the work of a laboratory will likely require a LIMS (laboratory information management system) for orchestrating test scheduling, sample management, and critical process automation. A top-of-the-line LIMS will also be capable of acquiring and channeling analytical data provide by testing and measurement instrumentation. It will also be able to provide advanced analytics for supporting trend identification and highlighting out-of-specification results.

By decreasing paper-based logging and reporting, accuracy, data security, and integrity can be improved. LIMS solutions providing bidirectional support of key systems will eliminate the need to manually transcribe results from instrument panels or onto other paper media, minimizing errors and data redundancy.

The STARLIMS solution provides out-of-the-box bidirectional support for CDS (chromatographic data systems) like Chromeleon and Empower, along with ERP (enterprise resource planning platforms) such as SAP.

STARLIMS Integrated Solution

Implementing state-of-the-art technology, STARLIMS provides a totally integrated solution that incorporates LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics, and Mobile within a single application. This innovation makes building and maintaining custom interfaces required by third-party tools unnecessary.

Part 2 will cover Automation of Crucial QA/QC Processes and Support of Data Integrity & QbD.

Alpha LIMS Implementation

Alpha has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha today at (410) 295-9500.