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GMP News No. 340
27 August 2003
FDA'sExpectations on the
21 CFR Section 211.25 of the American GMP rules for manufacturers of medicinalproducts contains the general demand for education, training, andexperience of laboratory staff.
In the Human Drug cGMP Notes,which FDA will send you by mail if you request them with reference to theFreedom of Information Act, somebody asked: "What level ofdocumentation is necessary to demonstrate that a lab analyst has theeducation, training and experience to perform laboratory analysis? Is itnecessary to document training on each specific method?"
Paul W. Haynie from FDA's Center for Drug Evaluation and Research(CDER) gave the following answer:
|"The CGMPs require adequately trainedpersonnel to perform analyses of drugs (21 CFR 211.25). Consequently,firms should document the specific training an analyst has received. Ananalyst who is trained in general analytical techniques as evidences bycoursework or degree (e.g. chemistry), and has been given in-housetraining and/or other OJT to show familiarity with the company’sspecific methods, could satisfy this CGMP requirement. |
There is no need to document analytical training for each individualproduct analysis when the analytical method for each of these productsfollows applicable general principles for which training is done. Forexample, once the analyst has been trained in the general technique ofHPLC they could be considered trained to perform HPLC analysis for a broadrange of dosage strengths and types. This applies to any common analyticalmethod used in laboratories, such as HPLC, FTIR, UV-Vis, Karl Fischer, GC,TLC, Dissolution, etc.
Sometimes a firm used a modification to a general technique, forexample incorporating a specialized detector. If a firm utilizes amodified technique to their product, we would expect to see documentationthat the analyst has been trained to use that technique."