1.3 Employee Orientation, Quality Awareness, and Job Training Program

This page will address various regulatory issues related to this section of the GMP Institute framework.  Click below to view the issues that are relevant to you.

Do the CGMP regulations require firms to keep as "raw data" results from employee CGMP training tests?

How would the CGMPs address the problem of cleanroom operators who are shedders or practice poor aseptic technique?

Do the CGMP regulations require firms to keep as "raw data" results from employee CGMP training tests?

Reference:
21 CFR Sections 211.25, Personnel qualifications, and
211.34, Consultants

No. Section 211.25 of the CGMP regulations requires that persons engaged in manufacture, processing, packing, or holding of a drug product have the education, training, and experience, or any combination thereof, to perform their jobs. The regulation also requires that employees receive training, on a continuing basis, in those aspects of CGMP that are pertinent to their duties.  However, the regulation is silent on training records.

Note that section 211.34 requires firms to retain records of the qualifications of consultants, along with the type of service they perform. 

In implementing section 211.25, it should be obvious that firms need some kind of documentation regarding their employees' qualifications. Accordingly, during your inspections it would be reasonable to ask firms to show you documentation of their employee qualification and CGMP training, for your case by case assessment.

Absence of training documentation combined with clear evidence that employees are not qualified to do their jobs would be appropriate observation on an FDA 483. However, absence of CGMP training test score records would not, by itself, warrant listing on the 483.

Reprinted from: FDA's HUMAN DRUG CGMP NOTES (Volume 7, Number 3) September, 1999.
This same text is also reprinted in Framework section 1.2.

How would the CGMPs address the problem of cleanroom operators who are shedders or practice poor aseptic technique?

References: 
See 21 CFR 211.42(c)(10), Design and construction features; 
211.25, Personnel qualifications; 
211.28, Personnel responsibilities; 
211.113 Control of microbiological contamination; 
Guideline on Sterile Drug Products Produced by Aseptic Processing, June 1987

To protect exposed sterilized product, personnel are expected to consistently maintain sterile gown quality and aseptic method standards. Investigators can use the referenced sections of the CGMP regulations when they encounter the issues of cleanroom employees who appear to be "shedders" or practice poor aseptic technique. The term "shedders" is popularly used to describe individuals from whom high or frequent counts of microorganisms are recovered, as compared to other personnel. In general, firms can prevent, monitor and solve this problem. Here are some principles to keep in mind.

Cleanrooms are defined by their low levels of both viable and nonviable particulates and these levels need to be monitored and kept under control. Humans are a chief source of particulate contamination in the cleanroom, although these contaminants may originate from a number of other sources. 

Firms can take a number of measures to minimize the levels of microbiological contamination introduced by cleanroom operators. Among the widely recognized key measures to control personnel-borne contamination are:

(1) following good hygiene standards;
(2) training in proper gowning techniques; 
(3) maintaining gown quality; and,
(4) following proper aseptic technique.

Per CGMPs, firms monitor and observe performance of individuals to detect problematic trends and ensure adherence to these practices. For example, retraining an individual in proper gowning technique can generally resolve the problem of adverse trends or a high spike in personnel monitoring data.

Nonetheless, despite effective execution of the above-listed measures, some individuals are natural shedders whose presence in a cleanroom may compromise product quality. It is not unusual for firms to reassign such employees to duties outside of the cleanroom.

Note that because some people are found to be shedders, not everyone will be suitable for cleanroom duty. Ultimately, it is such differences among cleanroom personnel which underscore the need to monitor and qualify cleanroom operations on each production shift.

Contact for further information: Richard L. Friedman, HFD-322, 301-594-0095; e-mail: friedmanr@cder.fda.gov .

Reprinted from: FDA's HUMAN DRUG CGMP NOTES (Volume 6, Number 3) September, 1998.
This same text is also reprinted in Framework section 6.2.