Inadequate Change Control for Written Procedures


Eugia Pharma Specialities Limited
Issued on:
Inspection Dates:
22 Jan 2024 to 02 Feb 2024
Eugia Pharma Specialities Limited 34 To 48 Plot No: 4, Unit - Iii; Tsiic, Sangareddy, Telangana, 502307
  • Justin A Boyd
  • Eileen A Liu
  • Anastasia M Shields

Detailed Analysis

Key Observations

  • The lack of comprehensive review and approval structures for changes in procedural documentation is indicative of systemic shortcomings in the change control management process, potentially impacting product quality and regulatory compliance.

Possible Root Cause :

  • Lack of clarity in change control procedures.
  • Inadequate training on the importance of proper documentation and review process for changes.
  • Insufficient oversight by the quality unit on change implementation and documentation.
  • Potential disconnect between departments regarding procedure changes and their impact assessment.

Corrective Action:

  • Review and update change control procedures to ensure clarity on drafting, reviewing, and approval processes.
  • Conduct comprehensive training for all staff involved in change management on proper documentation and review processes.
  • Implement a quality oversight mechanism to monitor all changes for compliance with written procedures.
  • Facilitate cross-departmental communication to ensure comprehensive impact assessments are conducted for all procedure changes.

Preventive Action

  • Establish a continuous training program on change control management for new and existing employees.
  • Integrate a mandatory review step by the quality unit for all draft changes to ensure compliance before implementation.
  • Introduce a change impact assessment tool to be used across departments for evaluating potential effects of proposed changes.
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