The GMP guidelines request an annual evaluation of the quality standards of a controlled product to determine the need for adjustments in product specifications and/or manufacturing and control procedures. Life Sciences Quality Control & Assurance provides product review and quality review inquiries to support pharmaceutical companies within the data analysis.
Product review inquiry
In the Product review inquiry, it is possible to specify one or multiple search criteria to filter the list of analytical results by entering the following search criteria:
Item number used to select the item number associated with the quality orders for analytical results to search for;
Site used to select the site associated with the quality orders for analytical results to search for;
Test group used to select the test group associated with the quality orders for analytical results to search for;
Test used to select the test for analytical results to search for;
From date and To date are used to specify the range of date sites for the search.
By clicking OK, the search results will be displayed in the Product review form, available in Life Sciences Quality Control & Assurance > Inquiries > Quality management > Product review.
Example
The Product review inquiry displays all quality order results for test “Bacterial Endotoxins”, item “RM1000-brf”, test group “USPI-288-1”, and site “1”.
Quality review inquiry
In the Quality review inquiry, it is possible to specify one or multiple search criteria to filter the list of analytical results by entering the following search criteria:
Item number – Used to select the item number associated with the quality orders for analytical results to search for
Site – Used to select the site associated with the quality orders for analytical results to search for
Test group – Used to select the test group associated with the quality orders for analytical results to search for
Reference type – Used to select the reference type associated with the quality orders for analytical results to search for
From date and To date – Used to specify the range of date sites for the search.
By clicking OK, the search results will be displayed in the Quality review form, available in Life Sciences Quality Control & Assurance > Inquiries > Quality management > Quality review.
Example
The Quality review inquiry displays all quality order results for test group “ENV21_001”, item “RMENV003”, reference type “Project”, and site “1”.