OBJECTIVE:

• This SOP establishes a comprehensive and EU-GMP–compliant system for receiving, recording, investigating, and resolving market complaints associated with both own manufactured and imported finished pharmaceutical products handled by Company

SCOPE:

• This SOP applies to all market complaints received from distributors, healthcare professionals, patients, and regulatory authorities concerning products that are either: Manufactured at company

RESPONSIBILITIES:

Quality Assurance (QA):

• • • Responsible for complaint receipt, assessment, investigation, documentation, and closure.

Qualified Person for Pharmacovigilance (QPPV):

• • Ensures compliance with adverse event and regulatory reporting.

Regulatory Affairs (RA):

• • Coordinates communication with competent authorities and suppliers.

Quality Control (QC):

• • Conducts laboratory testing and supports complaint evaluation.

Production:

• • Provides batch-related manufacturing data for internal investigations.

Import department / Supplier QA:

• • Manages coordination for imported finished product complaints.

Marketing & Sales:

• • Acts as initial contact with complainant and forwards complaints to QA.

DEFINATIONS:

• Market Complaint: Any communication alleging product quality, safety, efficacy, or labeling defect.
•  Critical Complaint: Defect posing potential risk to patient health or requiring product recall.
•  Major Complaint: Defect affecting quality but not life-threatening.
•  Minor Complaint: Non-critical issue such as appearance, labeling error, or missing leaflet.

PROCEDURE:

• Market complaints shall be handled differently for products manufactured by Company and for imported finished products received from approved suppliers. The handling process shall ensure that the responsible teams are identified, actions are traceable, and accountability is clearly defined.

For Own Manufactured Products:

Complaint Receipt and Logging:

• Marketing or Sales shall immediately forward any complaint to QA within 24 hours of receipt.
• QA shall acknowledge the complaint, register it in the Market Complaint Log, and assign a unique Complaint number.
• If a physical or product sample is provided, QA shall label and store it in the designated “Complaint Sample Area.

Initial Assessment:

• QA Head together with QPPV shall review complaint details to classify as Critical, Major, or Minor based on potential impact.
• Production Head and QC Head shall be informed for technical assessment and data retrieval.
• RA shall be alerted if authority notification may be required.

Formation of Complaint Investigation Team (CIT):

• For each complaint, QA Head shall constitute a CIT within 24 hours (Critical) or 3 working days (Major).
• The CIT shall include: QA Designee (Team Lead), Production Representative, QC Analyst, Engineering Representative (if equipment-related), Warehouse Representative (if storage/distribution-related) and RA/QPPV (Advisory role).
• Team members may increase or decrease according to the nature of complaint, classification of complaint.
• All team members shall be trained in complaint investigation and root-cause analysis.

Investigation:

• The CIT shall review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), deviation reports, stability data, and any related CAPA history.
• QC shall analyze retained samples and document results, if the product complaint is related to quality.
• Root cause shall be identified using the 5-Why or Fishbone method.
• Investigation findings shall be recorded in the Complaint Investigation Template (F/QA011/001 – 00).

Corrective and Preventive Action (CAPA):

• CAPA shall be proposed by the CIT and approved by QA Head.
• CAPA implementation shall be tracked through the Deviation/Change Control System.
• Effectiveness shall be verified during subsequent self-inspection or trend review.

Communication and Closure:

• QA shall prepare an interim response to the complainant within 15 days and a final report upon completion.
• Critical complaints shall be reported to the Competent Authority within 7 days.
• Major complaints shall be closed within 30 days from the date of receipt of complaint.
• Minor complaints shall be closed within 45 days from the date of receipt of complaint.
• QA Head shall close the complaint after verifying CAPA completion and archive all records for 1 year after product shelf life.

For Imported Finished Products:

Complaint Receipt and Logging:

• Marketing, Sales, or Distributor shall forward the complaint to Designee QA within 24 hours.
• Designee QA shall log the complaint, assign a unique Complaint Number, and immediately notify Supplier QA.
• Samples shall be retrieved from market if available and preserved in the designated complaint-sample area.

Initial Assessment:

• Designee QA and Supplier QA shall jointly classify the complaint as Critical, Major, or Minor.
• RA and QPPV shall review for potential regulatory reporting obligations.

Formation of Joint Investigation Team (JIT):

• For all Critical and Major complaints, Import QA shall initiate a Joint Investigation Team (JIT) within 24 hours (Critical) or 3 working days (Major).
• The JIT shall consist of: Designee QA Coordinator (Team Lead), Supplier QA Representative, Supplier Production/Technical Representative, Supplier QC Analyst, RA & QPPV (Oversight roles) and Distributor Representative.
• Team members may increase or decrease according to the nature of complaint, classification of complaint.

Investigation and Data Review:

• Designee QA shall verify transportation, storage, and handling conditions at the import warehouse before forwarding the complaint with supplier QA.
• Supplier QA shall coordinate with concerned departments within their organization for investigation.
• The Market complaint number shall be issued and initial details shall be filled in the market complaint report before sharing with supplier.
• The supplier complaint form used for investigation shall keep as investigation report.

Root Cause Analysis and CAPA:

• Supplier QA shall conduct root-cause analysis as per their Market Complaint SOP.
• Import QA shall review and approve CAPA proposal, monitor closure, and verify evidence of implementation.
• After review, if additional documents require to extend the investigation, Designee QA shall communicate with Supplier QA.

Regulatory Communication and Closure:

• RA shall coordinate with Supplier RA for authority notification of Critical complaints within 7 calendar days,
• Major complaints shall be closed within 30 days from the date of receipt of complaint.
• Minor complaints shall be closed within 45 days from the date of receipt of complaint.
• Designee QA shall prepare final summary report and submit to QA Head for approval.
• Complaint record shall be closed only after receipt of verified CAPA closure evidence from Supplier QA.
• All records shall be retained for 1 year after product shelf life.

Complaint Numbering System:

• Each complaint shall be assigned a unique identification number by QA at the time of logging.
• The numbering format shall be MC/YY/XXX for own manufactured product. Where,
  • • MC = Market Complaint
    • YY = Last two digits of the year (e.g., 25 for 2025)
    • XXX = Sequential running number starting from 001 each calendar year.
    • Example: MC/25/007, Represents the 7th complaint received in year 2025 for own manufactured product.
• The numbering format shall be IMC/YY/XXX for own manufactured product. Where,
  • IMC = Imported Market Complaint
  • YY = Last two digits of the year (e.g., 25 for 2025)
  • XXX = Sequential running number starting from 001 each calendar year.
  • Example: IMC/25/007, Represents the 7th complaint received in year 2025 for imported products.

REFRENCE:

• EU-GMP Part I, Chapter 8 – Complaints and Product Recall
• EU-GMP Part II (ICH Q7) – Section 15.2 Complaint Handling
• WHO TRS 986, Annex 2 – Quality Management in the Drug Industry

RECORDS:

 REVISION HISTORY.