GMP News
27 August 2003
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FDA's
Expectations on the
Training Documentation of Laboratory Staff
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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:
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"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."
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For your further education regarding this topic, we recommend you the following
laboratory-related events:
- FDA/EU
Requirements for Laboratory Computers and Records,
Vienna, Austria, 17-19 September 2003
- Education
Course Out of Specification Results and Post-course Workshop Failure
Investigation, Barcelona, Spain, 30 September - 2 October 2003
- LIMS:
Design, Implementation and Optimisation,
Madrid, Spain, 22-23 October
2003
- Reference
Standards, Berlin, Germany, 13-14 November 2003
- Stability
Testing in the Pharmaceutical Industry,
Barcelona, Spain, 18-19 November 2003
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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