Missing Written Procedures and Responsibilities

Overview

Company:
Maplerose Enterprises LLC dba Pencol Pharmacy
Issued on:
22-Aug-16
Feinumber:
3012248071
Inspection Dates:
08 Aug 2016 to 22 Aug 2016
Location:
1325 S. Colorado Blvd., Denver CO 80222
Investigators:
  • Zachery L Miller
  • Zachary A Bogorad
  • Michael E Maselli

Detailed Analysis

Key Observations

  • The absence of written responsibilities and procedures for the quality control unit indicates a significant gap in the firm's ability to ensure product safety, efficacy, and quality. Immediate action is required to establish and document necessary processes to maintain GMP compliance and prevent potential quality issues.

Possible Root Cause :

  • Inadequate definition and documentation of quality control unit responsibilities.
  • Lack of established procedures for key quality control and quality assurance activities.
  • Insufficient attention to the comprehensive documentation required for GMP compliance.

Corrective Action:

  • Develop and document comprehensive procedures detailing the responsibilities of the quality control unit across all aspects of production and administration.
  • Establish procedures for all listed areas lacking documented processes, ensuring they meet GMP standards and regulatory requirements.
  • Train the quality control unit and relevant personnel on the new or updated procedures and the importance of documentation.

Preventive Action

  • Implement a regular review and update cycle for all quality control procedures to ensure they remain effective and compliant with current regulations.
  • Enhance the oversight role of the quality control unit with clear authority to approve or reject all components, processes, and products.
  • Integrate a documentation management system that ensures accessibility and control of all procedures and reports relevant to quality control and assurance.
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