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To provide written instructions for records and record-keeping relating to dietary supplements. This SOP applies to dietary supplement records and record-keeping associated with current Good Manufacturing Practices and (serious) adverse events.
All Customer Service employees are responsible for following this SOP. Quality Control is responsible for following this SOP and understanding the following information:
Records produced relating to current Good Manufacturing Practices and (serious) adverse events will be kept per the schedule outlined belowRecord-keeping Requirements:
When records have been held for the full periods outlined in the table above, Quality Control will purge those records. Electronic records may be deleted.Hard copies may be destroyed. Note: Quality Control may decide to extend the record-keeping times at their discretion. All records outlined in the table or copies of all records, will be readily available during the retention periods for inspection and copying by the FDA when requested.
PURPOSE
RESPONSIBILITY
PROCEDURES
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