A comprehensive program to monitor raw material supplier quality is a strategic imperative that life science companies cannot afford to ignore.
Increasingly complex supply chains and globalized sourcing in Life Sciences manufacturing have created an environment of uncertainty regarding incoming materials quality and the need to monitor these materials more closely.
Because vendor-supplied Certificates of Analysis always show the material within specifications, the goal is to detect when these test results may be faulty, identify unusual and potentially dangerous trends, and reveal when a vendor may have changed their process, source material or manufacturing location.
Such due diligence simply requires applying current-generation analytics to all appropriate data.
4 Steps To Risk Reduction
A four step program will reduce these supply chain risks.
Step #1– Collect vendor-supplied test results into an accessible, validated database. The particular method depends on how vendors provide the data, which is usually in the form of a Certificate of Analysis. The three primary methods are:
- Manual data entry from printed or electronic images of Certificates of Analysis.
- Preferred – Automated import from electronic submissions via Excel (XLS) and other user-generated files.
- Preferred – Automated import from function-specific files and file formats such as CSV and XML.
The system must also include data validation and review to meet GMP and other regulatory standards.
Step #2– Integrate analytics applications with the systems managing Vendor Raw Materials test data via standard connection technology such as ODBC or database-specific interfaces.
Step #3 – Define specifications and the appropriate analytics for each data element acquired in Step #2.
Step #4–Create Dashboards, Reports and Notification Services for each user or group of users monitoring Vendor Raw Materials quality.
Not only does this process guarantee higher quality data and reporting from vendors, but it also provides the manufacturer a view of the supplier trends and the ability to rapidly detect supply quality changes or problems. The process is discussed in more detail in the June 2013 article, Improving Supply Chains Through Analytics in Pharmaceutical Manufacturing.