Biomedical Engineering Reference
In-Depth Information
(b) supervising the persons who are directly touching the
drug product.
2
How do these FDA regulations impact on these persons?
The regulations require that the pharmaceutical manufacturer
develop written SOPs that provide guidance for a broad
range of activities. These must be written procedures. As an
example of the failure to meet this requirement, consider
the FDA Warning Letter to Greer Laboratories, Inc., dated
24 June 2005: “Your fi rm failed to establish written
procedures applicable to the function of the quality control
unit.”
3
So a set of SOPs are required that will provide comprehensive
guidance for dealing with the inputs, processes, and outputs
of drug manufacturing, as well as quality control over this
manufacturing. Not only are written SOPs required; the
regulations insist the quality unit approves them - they are
controlled documents - and the procedures be followed.
These written procedures must be followed. As an example
of the failure to meet this requirement, consider the FDA
Warning Letter to Intermax Pharmaceuticals, Inc., dated
13 May 2003: “Although your fi rm has a written procedure
for training; it was found that these procedures are not
followed.”
4
Moving from the general to the particular, the FDA
regulations stipulate that all employees and supervisors be
trained. 21 CFR 211.25(a) states that each person engaged
in the manufacture of a drug product shall be trained:
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1. in the particular operations that the employee performs;
and
2. in current Good Manufacturing Practices (cGMPs);
3. including the cGMP regulations in chapter 211; and
4. the dozen or so written procedures required by these
regulations.
