Eurofins Lancaster Labs’ Quality Metrics program can help clients reduce FDA audits
FDA guidance requires comprehensive, consistent contractor management
The FDA recently issued a new guidance to the bio/pharmaceutical industry regarding contractor management, which detailed that manufacturers are ultimately responsible for all operations of the supply chain, including contract vendors. The agency is seeking to have efficient, flexible and compliant firms without extensive regulatory oversight by developing meaningful quality metrics, not just for the firm itself, but for all involved supply chain partners.
In order to meet the desired state required by FDA, firms must establish an effective quality system through implementation of a strong quality culture and proactive management. Companies that abide by this guidance and successfully present quality metrics to the FDA would potentially be considered low risk, thus decreasing the frequency of required audits by the FDA.
Eurofins Lancaster Laboratories has taken proactive measures to help our clients meet this requirement with the development of our Quality Metrics Report. The report serves as a score card to measure key quality and operational indicators throughout a client’s project with us.
All reports are available on our online data access portal, LabAccess.comSM where clients will also find a history of all previously saved reports to provide access to this important, historic information with the click of a button. We will also provide supporting documentation along with the report when needed.
Among the first laboratories to offer this report in response to the FDA’s new guidelines, we maintain a strong regulatory profile through successful inspections by the most prominent domestic and international authorities, such as FDA, EMA and DEA.
With a ratio of one quality staff member for every 10 technical staff members, our vast quality unit is able to sufficiently monitor our laboratory operations and procedures.
Type of Data Reported
While the report can be fully customized to meet individual needs, our standard metrics report includes key operational and quality indicators, such as:
- Total on-time release of test
- Out-of-specification (OOS)
- Out-of-trend (OOT)
- Non-representative result (NRR)
- Unplanned deviation
- Client requests or complaints
- Product related sample group
- Lab contaminated sample group
Types of Reports
- Project-specific report - shows data for a specific project
- Client report - shows data for any or all projects for the client
- Location or site-specific report - shows data for any or all projects from a particular client site
Frequency of Reports
The reports are automatically generated on a quarterly basis, but can also be performed for any defined time period per the client’s request. We can also provide retroactive reporting, as needed, to show up to three years of historical data.
Format of Reports
We provide the Quality Metrics Report in a spreadsheet format as shown here at left; however, we can also generate pivot tables (as shown above) for any of the quality indicators to allow you to identify common trends, understand the correlation between your data elements and further analyze your metrics.
