Archiving of Chromatograms: FDA provides important Clarification

In the section Questions and Answers on Current Good Manufacturing Practices, the FDA has answered an interesting question about the implementation of 21 CFR Part 211 and Part 11. The point is that some in industry misinterpret one part of the "Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Applications" and believe that in all cases paper printouts of electronic records are sufficient to comply with the requirements in 21 CFR Part 211 when testing medicinal products.

In its answer, the FDA specifically writes that for HPLC or GS systems and other computerised systems, the electronic records themselves must be retained. The FDA doesn't consider the printed paper copy of the chromatogram as a true copy of all electronic raw data because important information about the chromatogram would be missing.

Therefore, printed chromatograms only are not sufficient! The electronic data have to be maintained and must be readily available for review, e.g. during an FDA inspection.

The full text (see question 3) can be found in "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance - Records and Reports."

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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