Standard Operating Procedure for Customer Complaints Handling for Gels
1) Purpose
The purpose of this SOP is to establish procedures for the receipt, documentation, investigation, and resolution of customer complaints related to gels, ensuring timely response, investigation of root causes, and implementation of corrective actions to improve product quality and customer satisfaction.
2) Scope
This SOP applies to all personnel involved in the pharmaceutical manufacturing facility’s Customer Service, Quality Assurance (QA), Regulatory Affairs, and Production departments responsible for receiving, documenting, investigating, and resolving customer complaints related to gels.
3) Responsibilities
Customer Service: Receive and document customer complaints, ensuring accurate and timely recording of complaint details.
Quality Assurance (QA): Investigate customer complaints, assess product quality issues, and implement corrective actions to prevent recurrence.
Regulatory Affairs: Ensure compliance with regulatory reporting requirements related to customer complaints.
Production: Provide technical expertise and support in investigating root causes and implementing corrective actions.
4) Procedure
4.1 Receipt of Customer Complaints
4.1.1 Receive customer complaints through designated channels (e.g., customer service hotline, email, website).
4.1.2 Document complaint details, including product name, batch/lot number, nature of complaint, and contact information of the complainant.
4.2 Initial Assessment
4.2.1 Conduct an initial assessment of the complaint to determine severity, potential impact on patient safety, and regulatory implications.
4.2.2 Assign a unique complaint identification number and classify complaints based on urgency and seriousness.
4.3 Investigation
4.3.1 Initiate an investigation into the root cause(s) of the complaint, involving cross-functional teams as necessary (QA, Production, Regulatory Affairs).
4.3.2 Gather and review relevant information, such as batch records, quality control data, and customer feedback, to determine the cause of the complaint.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop and implement corrective actions to address identified root causes and prevent recurrence of similar complaints.
4.4.2 Document CAPA plans, including timelines for implementation and verification of effectiveness.
4.5 Customer Communication
4.5.1 Provide timely and clear communication to the customer regarding the investigation findings, actions taken, and resolution of the complaint.
4.5.2 Obtain feedback from the customer to ensure satisfaction with the resolution and address any further concerns.
4.6 Regulatory Reporting
4.6.1 Report customer complaints to regulatory authorities as per applicable regulations and timelines.
4.6.2 Maintain records of regulatory submissions related to customer complaints.
4.7 Trend Analysis and Reporting
4.7.1 Conduct trend analysis of customer complaints to identify recurring issues or patterns.
4.7.2 Report trends and findings to management and relevant departments for continuous improvement initiatives.
4.8 Documentation and Archiving
4.8.1 Maintain comprehensive records of all customer complaints, investigations, corrective actions, and communications.
4.8.2 Archive complaint records in accordance with company procedures and regulatory requirements.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
CAPA: Corrective and Preventive Actions
6) Documents, if any
– Customer Complaint Form
– Investigation Reports
– Corrective and Preventive Action (CAPA) Plans
– Customer Communication Records
7) Reference, if any
– FDA Guidance for Industry: Handling and Reporting of Quality Complaints
– ICH Guidelines for Pharmaceutical Quality Systems
– Company-specific customer complaint handling procedures and guidelines
8) SOP Version
Version 1.0
