Published: Sunday, January 1, 2012
Customize this SOP template to establish standard procedures for the receipt, documentation, investigation, and disposition of customer complaints. Note that federal regulations require only GMP-related product complaints to be documented and made available to FDA inspectors for review. Companies may wish to implement a separate SOP to cover non-GMP-related complaints.
The report log can be used to track complaint reports as required by 21 CFR §111.135 and §111.553-111.570. Detailed information about each complaint should be recorded on a Complaint Report.
The Complaint Report is to be completed by the employee who initially receives the complaint. When Section 1 is complete, route the form to QA management.
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