FDA's Expectations on the Training Documentation of Laboratory Staff

GMP News No. 340

GMP News
27 August 2003
 

FDA's Expectations on the
Training Documentation of Laboratory Staff

 
21 CFR Section 211.25 of the American GMP rules for manufacturers of medicinal products contains the general demand for education, training, and experience of laboratory staff. 

In the Human Drug cGMP Notes, which FDA will send you by mail if you request them with reference to the Freedom of Information Act, somebody asked: "What level of documentation is necessary to demonstrate that a lab analyst has the education, training and experience to perform laboratory analysis? Is it necessary 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 trained personnel to perform analyses of drugs (21 CFR 211.25). Consequently, firms should document the specific training an analyst has received. An analyst who is trained in general analytical techniques as evidences by coursework or degree (e.g. chemistry), and has been given in-house training and/or other OJT to show familiarity with the company’s specific methods, could satisfy this CGMP requirement. 

There is no need to document analytical training for each individual product analysis when the analytical method for each of these products follows applicable general principles for which training is done. For example, once the analyst has been trained in the general technique of HPLC they could be considered trained to perform HPLC analysis for a broad range of dosage strengths and types. This applies to any common analytical method 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, for example incorporating a specialized detector. If a firm utilizes a modified technique to their product, we would expect to see documentation that the analyst has been trained to use that technique."

 
For your further education regarding this topic, we recommend you the following laboratory-related events:

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
  

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