Published: Sunday, January 1, 2012
This SOP establishes procedures for documenting and investigating production failures. Production failure investigations are not required by 21 CFR 111. However, it is a good business practice to conduct production failure investigations. The goal of the investigation is not simply to determine the proximate cause of the failure (e.g. a lot of raw material was subpotent or contaminated), but also to identify whether other production batches are affected; to identify contributory factors and areas where the overall quality system needs to be strengthened; and to identify appropriate corrective and preventive actions to prevent recurrence of the problem.
Examples of issues to be examined during a production failure investigation might include (depending on the circumstances of the failure):
The report template may be used to report production failures.
The log can be used to track manufacturing failure investigations. Whenever a significant failure occurs in production, such as an unplanned occurrence adulterates the product or a manufactured batch fails to meet specifications, the company may want to conduct a failure investigation to determine the root cause of the problem and how it can be prevented in the future. Such failure investigations are not required by dietary supplement GMPs, but may be helpful to the company’s operations. Details about each investigation should be recorded on a Failure Investigation Report.
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