Integration of monitoring devices such as total organic carbon and endotoxin analyzers eliminates separate data flows from
these respective devices and the problem of an analyst having to manually enter the data into another system such as a laboratory
information management system (LIMS) database or spreadsheet. Data from these devices transfers directly into the system of
record, eliminating paper data recording, manual reconciliation, and transfer and reformatting. The data from the devices
is stored in a structured format to report, trend, and correlate the information obtained from other sources for immediate
Integrating the QC repository with in-process and continuous monitoring systems is a next crucial step in further automation.
In-process data in a common format with manual QC data provides a single view across production and quality assurance. Anomalies
in the sample can be correlated to the continuous monitoring performed when the manual sample was obtained. The single dataset
can provide critical information to identify potential contamination events before they interrupt production. The primary
objective is preventive action performed with real-time trend analysis, shorter investigation time, root-cause analysis, and
immediate alerts for critical events. With these tools, system trends such as seasonal mold can be identified, and cleaning
regimens adjusted proactively.
Comprehensive data reporting, analytics and trending tools, and a dedicated repository, or "data mart" combine relevant information
sources from production and QC. Custom analytical views or "dashboards" combine key performance metrics and user alerts with
targeted information that the user can apply in QC, production, or other production-release decisions. Trend analysis improves
over time and across processes. More importantly, the information can be used as a common communication tool between QC and
production. A QC test revealing contaminated water, for example, can be quickly communicated to production so that the water
is not used in any process.
The value of an automated QC process is measured by its ability to support product-release decisions for a wide range of pharmaceutical
products, thereby moving organizations toward the ultimate goal of release in full compliance with real-time information.
QC information needs to meet the following four requirements to support product-release decisions:
- A prioritized automated system must remove the bottlenecks and errors of manual data aggregation and redundant data entry.
The system must also reduce sample life-cycle times.
- The information must be detailed to support meaningful analysis. The information needed must provide maximum accuracy in a
minimal amount of time to answer all investigation inquiries.
- The information must be comprehensive. Information-management tools need to combine in-process monitoring, laboratory monitoring,
and product testing into a complete, role-based picture for decision makers.
- The information must be actionable. Dynamic maps and trends must be produced in seconds. There must be immediate alerts for
out-of-specification events to initiate investigation processes. Visual tools and on-demand trends are needed for preventive
action along with clear and detailed standardized reports for release records and regulatory audits.
The benefits of automatic mobile data acquisition and workflow, device and in-process integration, and common analytical standards
and tools include increased productivity, improved compliance, and faster product-release decisions. A fully integrated QC
process using these technology solutions is an important part of any regulated organization's process analytical technology
initiatives. An organization focused on producing high-quality, actionable QC information has the ability to continuously
improve a production process focused on delivering product of the highest quality with maximum efficiency.
Michael Goetter is director of informatics strategy, Lonza Wayne Inc., 1255 Drummers Lane, Suite 202, Wayne, PA 19087, tel. 484.253.1000 ext
101, fax 484.253.4054, firstname.lastname@example.org
Jeremy Tanner is product specialist, Lonza Walkersville Inc.
*To whom all correspondence should be addressed.
1. FDA, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice (Rockville, MD 2004).