Incomplete Adherence to Quality Control Protocols


CP Pharmaceuticals
Issued on:
Inspection Dates:
05 Oct 2015 to 13 Oct 2015
CP Pharmaceuticals, Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
  • Torrance J Slayton

Detailed Analysis

Key Observations

  • The observation highlights significant gaps in the Change Control process and data integrity practices, underlining the need for enhanced procedures, training, and oversight to ensure compliance and product quality.

Possible Root Cause :

  • Lack of a comprehensive Change Control system that encompasses all procedural and technological changes.
  • Inadequate training of staff on the importance of executing and documenting change controls.
  • Absence of a validated system for maintaining and ensuring the integrity of critical data such as CCTV footage.
  • Ineffective oversight by the Quality Control Unit over the implementation and documentation of changes.

Corrective Action:

  • Develop and implement a comprehensive Change Control SOP that requires documentation and approval for all changes affecting product quality.
  • Validate the system used for storing critical data, including CCTV footage, to ensure data integrity and availability.
  • Conduct refresher training for all employees on the importance of documenting Change Controls and maintaining data integrity.
  • Enhance Quality Control Unit oversight to review and approve all procedural changes and ensure changes are implemented as documented.

Preventive Action

  • Regularly review and update the Change Control SOP to adapt to new regulatory requirements and technological advancements.
  • Establish a routine schedule for training on data integrity, emphasizing the consequences of not maintaining or documenting crucial data.
  • Implement an automatic reminder system for the periodic validation of data storage and maintenance systems.
  • Introduce regular audits of the Change Control process and data integrity practices to identify and rectify gaps promptly.
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