Pharmaceutical
QA/QC Labs and Smart Infrastructure Equal End-to-End Quality by Design
Shanler recommends that manufacturers “prioritize end-to-end infor- matics investments and align metrics for innovation, domain expertise, operational efficiencies and quality.” His recommendation is based on an observation that today’s laboratories “are, for the most part, disconnected.”
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The move to a more connected laboratory is driven by both the productiv- ity drivers Gartner describes and significant technology improvements. The paperless lab has been discussed for the past 15–20 years, but it is finally happening and nowhere is this more evident than inside quality assurance/quality control (QA/QC) laboratories. Few QA/QC labs still cling to the paper-based notebook systems of the past and, while this is a critical step, it is only part of the story. There’s far more to becoming a paperless lab than simply eschewing paper. Labs must adopt a smart infrastructure that drives quality, not only in the lab, but throughout the organization. An integrated informatics solution is the engine that drives quality product release and a culture of continual process improvement.
Quality by Design In 2004, the FDA introduced Quality by Design (QbD) in “Pharmaceutical
cGMPs for the 21st Century—A Risk-Based Approach.”2 While this con-
cept is not new to many industries, it was the first attempt to apply these principles to the pharmaceutical industry. Quality by Design is built on the concept that well-understood products and processes are more efficient and produce higher-quality products resulting in less product nonconformance. The FDA’s goal was to improve pharmaceutical com- panies’ productivity, ensure patient safety, and prevent drug shortages in the marketplace. The quote below, from a 2012 FDA presentation on the pharmaceutical quality system, makes this point succinctly:
We rely upon the manufacturing controls and standards to ensure that time and time again, lot after lot, year after year the same clinical profile will be delivered because the product will be the same in its quality…. We have to think of the primary customers as people consuming that medicine and we have to think of the statute and what we are guaran- teeing in there, that the drug will continue to be safe and effective and perform as described in the label.” (Janet Woodcock, M.D.)
Uncompromising quality is essential to any pharmaceutical company. Informatics plays a critical role in ensuring that organizations realize the
n his report, “Product Innovation Requires Laboratory Informat- ics Systems to Transcend Phases,”1
Gartner analyst Michael
improved product quality and operational efficiency provided by adher- ence to QbD principles.
Today’s informatics infrastructure QA/QC laboratories need a tightly controlled process and a well-managed
laboratory to drive predictive analytics and to prevent substandard products before they occur. An end-to-end informatics solution warns the organization before nonconformances occur by monitoring critical product attributes creating a proactive versus reactive environment. Laboratories address these needs through the use of several systems: Lab Execution Systems (LES), Scientific Data Management Systems (SMDS), and Laboratory Information Management Systems (LIMS).
Lab Execution Systems LES has become a critical component of today’s paperless lab, ensuring
that quality processes are followed in the laboratory and that the methods built on QbD principles are followed in day-to-day laboratory operations. LES drives users through any laboratory procedure in a stepwise fash- ion. This provides technicians with the direction they need to execute processes safely, and in a consistent manner. It also assures laboratory management that good laboratory practices (GLPs) are used and that stan- dard operating procedures (SOPs) are being followed by experienced and newly trained laboratory personnel. Maintaining a consistent approach to activities like sample preparation, instrument calibration, maintenance, and analytical testing is critical to a good scientific process. Lab managers can then be certain that all of their results are a true assessment of final product quality.
Scientific Data Management Systems An SDMS lets you integrate instruments across the lab and centralize data
capture, allowing for long-term data archiving and, more importantly, data visualization from the archive—all accessed from the LIMS. An SDMS archives the original raw data files from the instrument along with a nor- malized representation in XML, without the need to restore the data to the original instrument workstation or install the instrument software on every computer.
The real scientific data and the results gleaned from them are a critical part of QbD. The final product specification is determined by comparing the analytical results to determine which formulation and process parameters
AMERICAN LABORATORY • 30 • JUNE/JULY 2014
by Trish Meek
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