Chemistry Reference
In-Depth Information
validation, documentation, and instrument categories. Additional information on
AIQ can be found in Chapter 2.
1.6.3 S
yStem
S
uItAbIlIty
According to the USP, system suitability tests are an integral part of chromato-
graphic methods [23]. These tests are used to verify that the resolution and reproduc-
ibility of, for example, a chromatographic system, are adequate for the analysis to
be performed. System suitability tests are based on the concept that the equipment,
electronics, analytical operations, and samples constitute an integral system that can
be evaluated as a whole. System suitability is discussed further in Chapter 5.
1.7 trAInIng
In a regulated laboratory, instruments must be qualified and methods must be vali-
dated to be suitable for their intended purposes. It is equally important, however,
that personnel are properly trained and qualified for the task at hand. The FDA
treats the use of untrained or unqualified laboratory personnel in a regulated labora-
tory the same as an adulteration of the drug substance or drug product. Even so, the
FDA still frequently cites firms for a lack of trained personnel; Table 1.5 lists some
tAble 1.5
examples of training deficiencies from Actual FdA 483 Warning letters
Failure to assure that the Quality Assurance Unit (QAU) director has adequate education, training, or
experience to perform his assigned functions 21 CFR58.29(a)]: “Any individual responsible for the
supervision of a non-clinical laboratory study must have education, training, and experience to enable
that person to perform his assigned functions. [21CFR 58.29(a)]. You appointed a member of your
management team to conduct the responsibilities of the QAU, but your documentation indicates that
this person did not have the training and experience to assume these duties.
Procedures for identifying training needs have not been followed [21 CFR 820.25(b)]. Specifically,
employee training needs were not addressed and training was not documented.
Persons engaged in manufacturing, processing or packing of drug and device products do not have
adequate training to enable those persons to perform the assigned functions. [21 CFR 211.25 (a)] and
[21 CFR 820.25 (b)].”
Failure to have adequate laboratory controls. Examples are as follows: Lack of adequate training for
laboratory analysts and manufacturing employees.
Failure to establish adequate procedures for identifying training needs and ensuring that all personnel
are trained adequately, as required by 21 CFR820.25(b). For example, training procedures did not
include: (a) training with regard to defects that might occur from the improper performance of their
jobs; (b) training with regard to defects and errors that might be encountered as part of specific job
functions; and (c) there was no documentation that QC employees who perform verification and
validation activities received training to make them aware of defects and errors that might be
encountered within their job functions.
“Our investigator documented deficiencies in your firm's training program, including associated
employee training records [21 CFR 606.20(b) and 21 CFR211.25(a)]: You did not retain employee
competency test documentation as required by your standard operating procedures.”
