Standard Operating Procedure for Handling Product Complaints in Vaginal Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for receiving, documenting, evaluating, investigating, and responding to complaints related to vaginal dosage forms.

2) Scope

This SOP applies to all complaints received from customers, distributors, healthcare professionals, and internal sources regarding vaginal dosage forms manufactured and distributed by the company.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for overseeing the complaint handling process. The Quality Control (QC) Department and Production Department are responsible for assisting in complaint investigations and implementing corrective actions.

4) Procedure

4.1 Receipt of Complaints

1. Receive complaints via phone, email, written correspondence, or other communication channels.
2. Document complaint details, including complainant information, nature of the complaint, product details, and any related documentation.

4.2 Evaluation and Classification

1. Evaluate the complaint to determine if it requires investigation based on severity, recurrence, or potential impact on patient safety.
2. Classify complaints based on type (e.g., quality, safety, efficacy) and urgency.

4.3 Investigation

1. Initiate an investigation to determine the root cause of the complaint.
2. Document investigation findings, including interviews, review of production records, testing results, and other relevant information.

4.4 Corrective and Preventive Actions (CAPA)

1. Develop and implement corrective actions to address identified root causes and prevent recurrence.
2. Assign responsibilities and establish timelines for implementing corrective actions.

4.5 Communication and Response

1. Communicate with the complainant to acknowledge receipt of the complaint and provide updates on the investigation and resolution process.
2. Provide a timely and appropriate response to the complainant, including investigation findings and corrective actions taken.

4.6 Documentation and Reporting

1. Document all steps taken during the complaint handling process, including investigation, corrective actions, and communication with the complainant.
2. Report complaint trends and recurring issues to management for review and potential quality improvement initiatives.

5) Abbreviations, if any

QA: Quality Assurance
QC: Quality Control
CAPA: Corrective and Preventive Actions

6) Documents, if any

Complaint form, investigation report, corrective action plan

7) Reference, if any

ICH Q10: Pharmaceutical Quality System, WHO Technical Report Series No. 996, Annex 5: WHO guidelines on good manufacturing practices for pharmaceutical products

8) SOP Version

Version 1.0