Inadequate Procedures for Managing Drug Complaints


Cipla Limited
Issued on:
Inspection Dates:
06 Feb 2023 to 17 Feb 2023
Plot No. 9 & 10, Pharma Zone Phase II, Section III, Indore Special Economic Zone, Pithampur, District Dhar, Madhya Pradesh, 454775
  • Saleem A Akhtar
  • Jose E Melendez

Detailed Analysis

Key Observations

  • The observed deficiencies in the complaint handling process indicate a systemic issue that requires comprehensive corrective and preventive actions to ensure effective management of complaints and continuous product quality improvement.

Possible Root Cause :

  • The procedures for handling complaints are not clearly defined or documented, leading to inconsistent practices.
  • Lack of proper training for personnel on how to effectively handle, investigate, and document complaints.
  • Inadequate oversight from the quality control unit to ensure compliance with established complaint handling procedures.
  • The system for logging and tracking complaints might be inefficient, leading to overlooked or inadequately investigated complaints.

Corrective Action:

  • Revise and clearly document the procedures for handling both written and oral complaints related to drug products, ensuring they include steps for investigation, documentation, and follow-up.
  • Implement a comprehensive training program for all personnel involved in the complaint handling process, focusing on the importance of thorough investigation and documentation.
  • Enhance oversight by the quality control unit to regularly review complaint handling practices and ensure adherence to procedures.
  • Upgrade or optimize the complaint logging and tracking system to ensure all complaints are adequately recorded, investigated, and resolved.

Preventive Action

  • Establish a regular audit program to review complaint handling procedures and their implementation, identifying areas for improvement.
  • Introduce a periodic review of the complaint handling process to incorporate changes in regulations, industry standards, and internal policies.
  • Implement a feedback loop from the complaint investigation outcomes to relevant departments for continuous improvement.
  • Engage in regular training refreshers for staff to stay updated on best practices in complaint handling.
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