Biomedical Engineering Reference
In-Depth Information
Training in current good manufacturing practice shall
be conducted by qualifi ed individuals on a continuing
basis and with suffi cient frequency to assure that
employees remain familiar with cGMP requirements
applicable to them.”
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Three points in this passage should be highlighted: the
training shall be “conducted by qualifi ed individuals,” shall
be conducted “on a continuing basis,” and shall address
“cGMP requirements applicable to them.”
Some FDA regulations tend to be more implicit. For
instance, in the section “Blood and Blood Components,” it is
stated that:
All personnel shall have capabilities commensurate
with their assigned functions, a thorough understanding
of the procedures or control operations they perform,
the necessary training or experience, and adequate
information concerning the application of pertinent
provisions of this part to their respective functions.
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The European Union makes a similar point about the need
for continuing training in GMPs:
Besides the basic training on the theory and practice of
good manufacturing practice, newly recruited personnel
should receive training appropriate to the duties
assigned to them. Continuing training should also be
given . . .
Health Canada also mandates continuing cGMP training, so
that “all personnel are aware of the principles of GMP that
affect them, and all personnel receive initial and continuing
training relevant to their job responsibilities.”
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