Inadequate Cleaning and Disinfection in Aseptic Areas

Overview

Company:
Pharmacy Resources Incorporated
Issued on:
23-May-17
Feinumber:
3002946837
Inspection Dates:
08 May 2017 to 23 May 2017
Location:
5290 East Yale Circle, Ste 101, Denver, CO 80222
Investigators:
  • Zachery L Miller

Detailed Analysis

Key Observations

  • The lack of a formalized and strictly followed document control procedure poses a risk to the integrity of documents and may lead to non-compliance with regulatory requirements.

Possible Root Cause :

  • Lack of a formal process for managing document changes, including drafting, review, and approval.
  • Insufficient training on the importance of following established document control procedures.
  • Inadequate oversight from the quality control unit to ensure compliance with document control procedures.

Corrective Action:

  • Establish a formal document change control procedure that clearly defines the process for drafting, reviewing, and approving documents.
  • Conduct training sessions for all relevant personnel on the importance of adhering to document control procedures and the role of the quality control unit in ensuring compliance.
  • Implement regular audits to verify adherence to document control procedures and take corrective actions for any non-compliance identified.

Preventive Action

  • Integrate an electronic document management system that enforces a workflow for the drafting, review, and approval of documents.
  • Develop a training program that includes periodic refreshers on document control procedures to reinforce the importance of compliance.
  • Increase the oversight role of the quality control unit in document management to ensure continuous adherence to procedures.
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