Standard Operating Procedure for Complaint Handling in Otic Manufacturing Unit
1) Purpose
To establish procedures for receiving, documenting, evaluating, investigating, and resolving complaints related to Otic (Ear) Dosage Forms to ensure customer satisfaction and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the receipt, assessment, investigation, and resolution of complaints within the Otic manufacturing unit.
3) Responsibilities
Quality Assurance (QA) Department: Responsible for overseeing the complaint handling process.
Customer Service Department: Responsible for initial receipt and documentation of complaints.
Quality Control (QC) Department: Responsible for investigation and resolution of complaints.
Production Department: Responsible for providing necessary information and support during complaint investigations.
4) Procedure
4.1 Complaint Receipt and Documentation
4.1.1 Receipt of Complaint
4.1.1.1 Customer Service receives complaints via designated channels (phone, email, website, etc.).
4.1.1.2 Document complaint details including product name, lot number, nature of complaint, and contact information.
4.1.2 Initial Assessment
4.1.2.1 QA verifies completeness and accuracy of complaint information.
4.1.2.2 Assign unique complaint identification number and classify severity.
4.2 Complaint Evaluation and Investigation
4.2.1 Investigation Plan
4.2.1.1 QA develops investigation plan based on complaint details and severity.
4.2.1.2 Define investigation team and timeline for completion.
4.2.2 Root Cause Analysis
4.2.2.1 QC conducts thorough investigation to determine root cause of the complaint.
4.2.2.2 Document findings, including corrective and preventive actions (CAPAs).
4.3 Corrective and Preventive Actions (CAPAs)
4.3.1 CAPA Development
4.3.1.1 QA reviews investigation findings and recommends appropriate CAPAs.
4.3.1.2 Implement corrective actions to address immediate issues and preventive actions to prevent recurrence.
4.3.2 CAPA Effectiveness
4.3.2.1 Monitor and verify effectiveness of implemented CAPAs.
4.3.2.2 Update complaint file with CAPA status and closure details.
4.4 Customer Communication
4.4.1 Response to Customer
4.4.1.1 QA drafts response to customer detailing investigation findings and actions taken.
4.4.1.2 Provide timeline for resolution and offer compensation or replacement if applicable.
4.4.2 Follow-Up
4.4.2.1 Customer Service follows up with customer to ensure satisfaction with resolution.
4.4.2.2 Document customer feedback and update complaint record accordingly.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions
6) Documents, if any
Complaint log and tracking system
Investigation reports
CAPA documentation
7) Reference, if any
GMP guidelines for complaint handling in pharmaceutical manufacturing
8) SOP Version
Version 1.0
