RI-ERP-FINALACTION-Recommendations

OMAMAN-20 C/ In House Validation Report ERP Use Only - March 2015

4.1.5

Shelf-life, Lot-to-Lot Stability and Comparability Study

Five independent lots of RIDA ® QUICK Gliadin were tested to ensure consistent manufacturing between lots and to support the reported shelf life of the test. For RIDA ® QUICK Gliadin, the maximum shelf life is 18 months. The quality assurance at R-Biopharm AG consists of a final in- process testing (not shown) in the production with final components followed by the official product batch release testing by the quality assurance department and additional real time stability testing after regular storage intervals (usually approx. 6 months). To show that the proposed shelf life was correct, the testings were prolonged for an additional 6 months for each lot. Table 7 shows the comparison of 5 different lots tested over a period of 24 months during routine QC testings. For each concentration and time point a single determination was performed. The WGPAT material was used as an alcoholic solution at indicated concentrations. It is clearly shown that all lots had a minimum shelf life of 18 months. No general loss of sensitivity has been observed over storage time and all negative samples were found negative throughout the shelf life.

Table 7. Lot-to-Lot Stability and shelf-life; the concentration of the tested gliadin solution includes the last dilution step of 50 µL extract plus 500 µL sample diluent; the day of the QC certificate is day 0; for each concentration and time point a single determination was performed.

ng/mL

20 10

5 2,5 1,25 0

QC certificate +

+ + + +

+ + + +

-

- - - -

- - - -

Lot E88

12months

+ + +

+

exp. 2014-08 18months

- -

24months

ng/mL

20 10

5 2,5 1,25 0

QC certificate +

+ + + +

+ + + +

- -

- - - -

- - - -

Lot E87

12months

+ + +

exp. 2014-05 18months

+ +

24months

ng/mL

20 10

5 2,5 1,25 0

+ + + + AOAC Research Institute Expert Review Panel Use Only - - - - - - - - - - - + + + + + + + - 20 10 5 2,5 1,25 0 -

QC certificate +

Lot E85

12months

exp. 2014-03 18months

24months

ng/mL

QC certificate +

+ + + +

- - -

- - - -

- - - -

Lot E84

12months

+ + +

+ + +

exp. 2013-11 18months

24months

+

ng/mL

20 10

5 2,5 1,25 0

QC certificate +

+ + + +

+ + + +

- -

- - - -

- - - -

Lot E83

12months

+ + +

exp. 2013-09 18months

+ +

24months

Page 18 of 27

RIDA®QUICK Gliadin Validation report 2015-01-14