FDA Warning Letters relating to Computerised Systems

Significant violations of GMP are published by the US FDA in Warning Letters. The GMP complaints always refer to the relevant section of the American GMP rules CFR 21 Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals. Actually, parts of two Warning Letters address in detail problems in connection with computerised systems. The point of reference 211.68 deals with "Automatic, mechanical, and electronic equipment".

1. Compania Internacional de Comercio, S.A. de C.V. under point 5:
Your firm has not established and documented the accuracy, reliability and performance of your computer systems employed in the release of drug products [21 C.F.R.  211.68 (a)]
 
2, Shamrock Medical Solutions Group LLC under point 1:
Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].

 Author:Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)