Over the last 12 months the US Food and Drug Administration (FDA) has been stepping up their audit activity, including at medical gas facilities. B&R Compliance (br compliance.com) offers clients an analysis of the kinds of questions FDA inspectors are asking, and the areas of the Good Manufacturing Practice (GMP) regulations that the FDA is focusing on.
We look for trends and changes in the agency’s thinking on compliance in the medical gas industry so that our customers can prepare for their next FDA audit. This article examines those trends.
Training of employees is something the FDA routinely focuses on during inspections. Recent audits highlight some new trends in this area, such as the agency’s close focus on the duration of time between training events. The Code of Federal Regulations (CFR) stipulates that employees shall be trained with sufficient frequency to ensure they are knowledgeable about their tasks and job responsibilities. The FDA is comfortable with regular training events that provide employees small frequent bites of training, but the agency now appears to have established a hard threshold of time—a maximum of one year—between GMP training events. Specifically, they are looking for the elapsed time between training events to not exceed 12 months. In recent audits, firms not meeting this requirement have been cited by the FDA as having inadequate employee training programs.
The FDA also is now looking closely at training content, going beyond a review of the recording of a training event, and asking to see the training agenda and materials. Auditors are making assessments on the adequacy of training materials and are clearly looking to see that a minimum level of competency is being met. Inspectors also are checking to see if firms have updated their training to reflect the latest trends and requirements in the GMP regulations. Firms that are using older materials are getting citations.
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