Ensuring Complete Records of Discrepancy Investigations

Overview

Company:
Sichuan Deebio Pharmaceutical Co. Ltd.
Issued on:
08-Sep-23
Feinumber:
12420
Inspection Dates:
04 Sep 2023 to 08 Sep 2023
Location:
15 She, Gaocao Village, Xiaohan Town, Guanghan, Sichuan, 618304
Investigators:
  • Arsen Karapetyan
  • Anders W Evenson

Detailed Analysis

Key Observations

  • The deficiency in the investigation process and documentation practices may compromise the ability to identify and address root causes effectively, potentially leading to recurring quality issues and impacts on product quality and safety.

Possible Root Cause :

  • Lack of clearly defined procedures for conducting thorough investigations and documenting conclusions and follow-up actions.
  • Insufficient training or oversight of personnel responsible for conducting investigations and documenting outcomes.
  • Inadequate documentation and record-keeping practices, leading to incomplete or missing investigation records.
  • Failure to extend investigations to other potentially impacted batches or to adequately evaluate critical equipment and manufacturing processes.

Corrective Action:

  • Develop and implement comprehensive SOPs for conducting investigations into discrepancies and failures, ensuring that all required elements, including conclusions and follow-up actions, are clearly defined and documented.
  • Conduct training sessions for quality control and investigation teams on the importance of thorough documentation and the proper execution of investigations.
  • Review and enhance record-keeping practices to ensure that all investigation-related documents are accurately maintained and readily accessible.
  • Expand the scope of investigations to include a review of all potentially impacted batches and a thorough evaluation of relevant equipment and manufacturing processes.

Preventive Action

  • Establish a regular training program for employees involved in the investigation and documentation process to reinforce best practices and procedural adherence.
  • Implement a periodic review of investigation records by senior quality personnel to ensure compliance with SOPs and completeness of documentation.
  • Use a digital tracking system for investigations to improve data integrity, facilitate trend analysis, and ensure accountability and traceability of actions taken.
  • Incorporate a risk-based approach in the investigation process to prioritize issues and focus on systemic root causes.
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