SOP Title: Handling of Market/Customer Complaints

OBJECTIVE

To establish a standardized procedure for the receipt, documentation, investigation, and resolution of market/customer complaints related to APIs and intermediates, ensuring prompt action, compliance, and continual improvement.

SCOPE

This procedure applies to all complaints concerning product quality, appearance, labelling, packaging, reliability, safety, and efficacy.

RESPONSIBILITY

• Marketing
  • Notify Quality Assurance (QA) of quality-related complaints
  • Acknowledge receipt of complaints
  • Coordinate all customer communications in collaboration with QA
• Site Quality Assurance (QA)
  • Log complaints in the designated register/log
  • Notify relevant departments and coordinate joint investigations
  • Conduct preliminary classification of complaints
  • Perform impact and risk analysis based on investigation outcomes
  • Prepare investigation reports, close complaints, verify CAPA effectiveness, and maintain complaint trends
• Head QA / Quality Head or Designee
  • Review and approve investigations and complaint classifications
  • Final classification of complaints (confirmed/non-confirmed)
  • Approve investigation extensions when applicable
• Investigation Team
  • Conduct complaint investigations
  • Provide support from manufacturing and packaging operations
  • Assist in root cause identification and data collection
• Site Quality Head / Corporate QA Head / Head QA or Designee
  • Approve extensions to investigation timelines as required

DEFINITIONS

• Complaint: Any written, electronic, or verbal communication indicating a potential deficiency in the identity, quality, reliability, safety, or efficacy of a product after it has been released for distribution or further processing.
• Confirmed Complaint: A complaint substantiated through investigation, with the root cause traced to a failure or error within established processes (e.g., manufacturing, testing, or documentation).
• Non-Confirmed Complaint: A complaint that, after thorough investigation, is found to have no attributable cause within established operations or systems.
• Quality: The extent to which a product, system, or process meets specified requirements or expectations.
• Safety: The assurance that no adverse effects will occur under defined and intended usage conditions.
• Purity: The proportion of the intended API in a sample, relative to impurities, residual solvents, or related substances.
• Efficacy: The ability of a product to produce the intended therapeutic effect under ideal or controlled conditions.
• Primary Packaging: The packaging component that is in direct contact with the drug substance (e.g., container, closure, and label).
• Secondary Packaging: Outer packaging materials that are not in direct contact with the product but provide added protection and support (e.g., cartons, boxes).

PROCEDURE

Complaint Intimation and Logging-

• The Marketing team shall inform the respective Site Quality Assurance (QA) department of any market or customer complaint via email or telephone.
• Telephone communication will be treated as initial intimation, followed by a detailed written complaint via email.
• Upon receipt of a complaint, QA shall log the complaint in the Market Complaint Logbook within 1 working day.

Complaint Numbering System-

• The complaint shall be assigned a unique number using the format:
  L-XXX/YYYY, where:
  • L = Location code
  • XXX = Sequential complaint number for the current year (e.g., 001, 002, 003, etc.)
  • YYYY = Four-digit calendar year
    Example: The first complaint logged at in 2024 will be numbered as L-001/2024.

Complaint Acknowledgment-

• QA shall acknowledge the receipt of the complaint within 3 working days through the Marketing team or relevant department.

Review of Historical Complaints-

• QA shall review any previous complaints related to the same product/batch and also check for similar complaints received within the past 12 months. This information shall form part of the investigation.

Complaint Investigation Form

• QA shall initiate the investigation by issuing the “Market / Customer Complaint Investigation Form”

Initial Complaint Assessment-

• QA shall perform an initial assessment
  • Formation of a cross-functional investigation team is recommended.
  • An initial classification of the complaint as Critical, Major, or Minor shall be made at the time of receipt.
  • Final classification will be made post-investigation, in accordance with the Risk Assessment SOP using the prescribed risk classification form.

Complaint Classifications: –

• • Critical: Direct impact on product quality and/or patient safety.
  • Major: Potential impact on product quality and/or patient safety.
  • Minor: No impact on product quality or patient safety.

Complaint Investigation Process-

• The Investigation Team shall conduct the investigation and prepare a report, which includes:
  • Investigation Details
  • Root Cause Analysis (RCA)
  • Risk Assessment (RA)
  • Impact Assessment (IA)
  • Corrective and Preventive Actions (CAPA)
  • Conclusion

Objective:

To identify the root cause of the complaint, evaluate associated risks or impacts, and define CAPAs to prevent recurrence.

Background:

Summarize the reason for initiating the investigation, including reference to similar past complaints, CAPAs, or trends.

Investigation:

• Develop an investigation plan and select appropriate root cause analysis techniques.
• Refer to any prior related complaints or documentation.
• Conduct additional hypothetical analysis or experiments, if required, using QA-approved protocols.

Root Cause Analysis (RCA):

• Identify all possible causes of the issue.
• Challenge each with scientific principles, documented evidence, audits, or experimental data.
• If the root cause remains inconclusive, list all probable causes with scientific justification.

RCA Tools may include (but are not limited to):

• Brainstorming
• Fishbone Diagram
• 5-Why Analysis
• Flowchart
• Pareto Chart
• Scatter Diagram
• Control Charts
• FMEA (Failure Modes and Effects Analysis)
  
  

Risk Assessment (RA):

• Identify risks and propose measures to reduce or mitigate them.
• Conduct RA as per respective SOP
• If the assignable cause is identified,  RA should proceed only upon confirmed root cause.

Impact Assessment (IA):

• Assess the impact on other batches, products, systems, or procedures that may have been affected.

CAPA:

• Document any immediate corrections.
• Define CAPAs addressing root causes and preventing recurrence.
• Evaluate the applicability of CAPAs to other products, areas, or departments.
• Verify CAPA implementation and effectiveness as per relevant SOP.

Conclusion: Summarize the investigation findings, scientific rationale, and final disposition of the batch. Include references and evidence.

List of Attachments:

Provide a comprehensive list of all related annexures and supporting documents, including reference numbers and titles.

Sign-Off of Investigation Report-

The Investigation Team shall complete and sign off the investigation report upon finalization.

Review and Evaluation of Investigation Report-

The Site Quality Head / Designee shall evaluate the investigation report, confirming the following (as applicable):

• Review and finalize the classification of the complaint post-investigation.
• Determine if a deviation needs to be logged. If yes, handle as per the SOP on Handling of Deviations.
• Assess whether an Out of Specification (OOS) needs to be logged separately. If yes, follow the SOP on OOS.
• Evaluate the need to block sales/distribution of the batch(es). If required, notify the Sales/Commercial teams.
• Decide if a product recall is necessary. If yes, initiate as per the site-specific SOP on Recall of Goods.
• Assess if the material has been returned due to quality rejection. If yes, manage as per the site-specific SOP.

Actions in Case of Critical Complaints-

For critical complaints, the Site Quality Head / Designee shall take immediate action to:

• Block sale/distribution of the batch or product in the market.
• Prepare and send an interim investigation report to the customer via the Marketing team.
• Inform all affected customers where the batch was distributed.
• Direct communication with customers is permitted in urgent or exigent situations.

Post-investigation:

• Classify the complaint as Confirmed or Not Confirmed.
• If confirmed, further categorize based on investigation findings.
• If Not Confirmed, treat it as a Minor complaint.
• Complaint closure shall be executed after final review and approval by the Head QA / Site Quality Head / Designee.

Investigation Timeline, Extensions, and Closure-

The investigation must be completed within 30 working days from the date of complaint logging.

If not completed in this timeframe, an extension must be initiated.
Note: Critical complaints must be prioritized regardless of the standard timeline.

The investigation report shall be shared with the customer via the Marketing department or other appropriate channels.

If the customer does not respond within 30 working days of report issuance, the complaint may be closed.

If the customer responds within the timeframe requesting additional investigation/data, an addendum investigation shall be initiated and tracked.

Complaints re-opened post-closure shall be logged again using the format:
L-XXX/YYYY-R

• Where R denotes a reopened complaint.
  Example: P2-001/2024-R

A maximum of three extensions may be granted:

• 1st Extension: Approved by Head QA / Designee
• 2nd Extension: Approved by Site Quality Head
• 3rd Extension: Approved by Next level

Each extension must not exceed 30 working days, and must include:

• Justification
• Original closure date
• Current investigation status
• Reason for delay
• Proposed new closure date

If the complaint remains unresolved after the third extension, a deviation shall be initiated by QA.

Numbering System for Addendum Reports-

The original title of the investigation report remains unchanged. Only the revision number shall be updated.

Format:
IVR / Complaint No. / Product Code / R#

• R0 = Original report
• R1, R2… = Subsequent addendum reports

Handling of Complaint Samples-

If samples are received from the customer:

• Capture sample details in Annexure
• Handle receipt, analysis, and destruction as per site-specific SOPs

Document Review-

Conduct a comprehensive review of:

• Batch records
• Area and equipment logbooks
• Analytical records
• Related batches (e.g., campaign batches)

Repeated or Complex Complaints-

For repeat complaints of the same nature:

• Investigations may involve joint audits or site visits.
• Third-party auditors may be engaged if required, ensuring they are qualified as per internal procedures.

Repeated Complaints – Action Threshold-

If three similar complaints are received:

• Suspend further supplies until RCA and CAPA are finalized and mutually agreed with the customer.

Chronology Document for Repeated Complaints-

For more than three repeat complaints:

• Prepare a chronology document summarizing:
  1. Complaint reference numbers
  2. Short descriptions
  3. Batch numbers
  4. RCAs
  5. Risk Assessment report numbers
  6. CAPA reference numbers
  7. Other relevant information

Retain Sample Analysis-

Retain sample analysis shall be performed at the discretion of the Head QA / Designee.

Complaint Sample Requirement-

In case of quality-related complaints, a sample from the customer may be requested for a thorough investigation.

Microbiological Analysis-

Where applicable, microbiological testing must be performed prior to any chemical analysis, especially when opening retain/control sample containers.

Risk Assessment-

Conduct risk evaluation for other products/batches

Investigation of Possible Causes-

List all potential causes and conduct a systematic investigation of each.

Final Root Cause and Problem Extent-

Draw a conclusion based on findings:

• Identify most probable root cause
• Assess the scope of the issue
• Provide scientific rationale

Original Test Result Inquiries-

When the complaint pertains to batch test results, the investigation shall include:

• Review of analytical data and equipment logbooks
• Interviews with involved personnel
• Risk assessment for other batches/products

Sterility-Related Complaints (Sterile Products)

For complaints involving sterility:

• Investigate as per respective SOP
• Consider sampling/testing methodology and customer handling practices
• If needed, exchange videos/photos for risk visualization and analysis

Escalation for Repeated Issues

If prior complaints exist for the same product or batch:

• QA must discuss with the Plant Head, Quality head

Communication with Customer

Investigation findings shall be shared with the customer along with relevant supporting documents.

Communication to Other Customers-

If a complaint is confirmed, assess the impact on other customers who received the same batch. If impacted, inform them via email communication.

Product Recall and Regulatory Notification-

In cases where the complaint investigation leads to a product recall, the Site Quality Head / Designee shall notify the local FDA and/or applicable international regulatory authorities as required.
If a quality failure is confirmed during the investigation, a recall shall be initiated for all affected customers as per the site-specific SOP on Recall of Goods.

Documentation and Records Management-

All investigation-related documentation shall be compiled and maintained for each customer complaint, including but not limited to:

• Investigation reports (initial, interim, and final)
• Uncontrolled copies of initial analysis data
• Reanalysis data
• Original hypothesis analysis data
• Customer communication records

For complaints involving the presence of foreign particles or material, identification and characterization of the foreign matter shall be performed and documented.

Annual Trend Analysis of Customer Complaints-

The Site Quality Head / Designee shall conduct an annual trend analysis of customer complaints categorized by product, complaint type, and classification (Critical/Major/Minor).
Classification is initially determined by QA during pre-evaluation and finalized by the Site Quality Head / Designee post-investigation.

Document Numbering System for Trending:

AA/MC/BBBB/CC

• AA: Department code (e.g., QA)
• MC: Market/Customer Complaint
• BBBB: Year (four digits)
• CC: Revision number (R0, R1, etc.)

Trend Analysis Scope Includes (but is not limited to):

• Total complaints received
• Number of invalid complaints
• Number of valid complaints
• Occurrence of repeat complaints for the same product
• Need for extended investigation reports, joint analysis, audits, or visits
• Status of CAPA implementation
• Deviations logged due to complaints
• Adherence to document numbering systems
• Cross-referencing and archival of associated risk assessments
• Other relevant points raised during Management Review

The completed trend analysis report shall be finalized by end of January each year, covering the previous calendar year.

A summary of the evaluation shall be shared with the Corporate Quality Head and the Managing Director for their review and feedback.

REFERENCE

Systematic Approach for Complaint Handling in Pharmaceutical Industries

ABBREVIATIONS