Standard Operating Procedure for Complaint Handling in Ointment Formulation
1) Purpose
The purpose of this SOP is to establish a procedure for handling complaints related to ointment products, ensuring timely investigation, resolution, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the receipt, investigation, and resolution of complaints related to ointment products.
3) Responsibilities
– Customer Service: Responsible for receiving and documenting complaints.
– Quality Assurance (QA): Responsible for investigating complaints and determining root causes.
– Production Staff: Responsible for providing information and support during complaint investigations.
4) Procedure
1. Receipt of Complaints:
1.1 Documentation:
1.1.1 Document all complaints received in a complaint log.
1.1.2 Include details such as the complainant’s name, contact information, product details, and nature of the complaint.
1.2 Initial Assessment:
1.2.1 Conduct an initial assessment to determine the severity of the complaint.
1.2.2 Prioritize complaints based on potential impact on product quality and patient safety.
Investigation:
2.1 Investigation Plan:
2.1.1 Develop an investigation plan outlining the steps to be taken.
2.1.2 Assign responsibilities for each step of the investigation.
2.2 Data Collection:
2.2.1 Collect relevant data, including production records, batch records, and retention samples.
2.2.2 Interview personnel involved in the production of the affected batch.
Root Cause Analysis:
3.1 Analysis:
3.1.1 Conduct a root cause analysis to identify the underlying cause of the complaint.
3.1.2 Use tools such as Fishbone Diagrams, 5 Whys, or Failure Mode and Effects Analysis (FMEA).
3.2 Corrective Actions:
3.2.1 Develop and implement corrective actions to address the root cause.
3.2.2 Document the actions taken and their effectiveness.
Resolution and Follow-Up:
4.1 Response to Complainant:
4.1.1 Provide a written response to the complainant detailing the findings and actions taken.
4.1.2 Ensure the response is timely and addresses the complainant’s concerns.
4.2 Follow-Up:
4.2.1 Monitor the effectiveness of corrective actions through follow-up investigations.
4.2.2 Update SOPs and training programs based on findings to prevent recurrence.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FMEA: Failure Mode and Effects Analysis
6) Documents, if any
– Complaint Log
– Investigation Reports
– Corrective Action Reports
– Customer Responses
7) Reference, if any
– FDA Guidance for Industry: Handling and Reporting of Adverse Events
– WHO Guidelines on Pharmacovigilance
8) SOP Version
Version 1.0
