During the past 15 years, the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) have tasked pharmaceutical companies to review their manufacturing and development processes and determine the basis of a QbD (Quality by Design) approach for their product life cycles.
The objective of QbD is to ensure medicine quality through the utilization of analytic, risk-management methodology, and statistical methods during the design, development, and manufacturing processes.
Based on the principles of a comprehensive understanding of the character and behavior of materials, QbD is used to create high-quality processes during the entire product life cycle. The goal is to consistently produce safer and higher quality drugs by significantly decreasing the probability of failure at every stage.
In 2016, the FDA released and requested comments on “Data integrity and compliance with cGMP guidance for the industry,” a guidance drafted due to an increasing number of cGMP violations related to data integrity. The paper’s goal was to clarify the role of data integrity in cGMP (current good manufacturing practice) for drugs, as set forth by 21 CFR parts 210, 211, and 212.

Modern Lab Digital Infrastructure

The modern automated and data-intensive laboratory environment requires QbD and data completeness/integrity principles to support QA/QC (Quality Assurance/Quality Control). The implementation of a thorough and smart informatics infrastructure will ease this task.
Modern lab digital infrastructure is chiefly based on LIMS (laboratory information management system) functionality for the control and coordination of test scheduling, sample management, and automation of critical processes. Along with providing housekeeping operations, current top-performing LIMS obtain measurement and test data directly from lab instruments and provide advanced analytics.
The reduction of manual record keeping and related paper-based processes helps increase data accuracy, integrity, and security. Implementing STARLIMS, an integrated solution that provides bidirectional support for crucial systems, will help eliminate the need for analysts to transcribe instrument panel data, which helps minimize mistakes and redundancies.
Part 2 will discuss Automation of Critical Processes, Data Integrity, and Holistic Solution.
Alpha Engineering LIMS Implementation
Alpha Engineering Associates, Inc. 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 Engineering Associates today at (410) 295-9500.