Lack of SOP and Documented Procedures

Overview

Company:
Time Cap Labs, Inc.
Issued on:
05-May-98
Feinumber:
2431898
Inspection Dates:
26 Mar 1998 to 05 May 1998
Location:
7 Michael Avenue, Farmingdale, New York 11735
Investigators:
  • Lawrence Farina
  • Robert C Horan

Detailed Analysis

Key Observations

  • Critical gap in the quality management system due to the absence of SOPs for vendor and laboratory qualification, leading to potential risks in product quality and regulatory compliance.

Possible Root Cause :

  • Absence of Standard Operation Procedures (SOPs) for vendor qualification, which suggests a gap in the quality management system.
  • Lack of awareness or understanding of the regulatory requirements for vendor and laboratory qualification.
  • Inadequate resource allocation for quality assurance activities, including auditing and vendor qualification
  • Potential miscommunication or oversight regarding the importance of vendor qualification and its impact on product quality.

Corrective Action:

  • Develop and implement a comprehensive SOP for the qualification of vendors and contracted laboratories, emphasizing regulatory compliance and quality assurance.
  • Allocate necessary resources and personnel for the process of vendor and lab qualification, including training on the importance of this activity.
  • Conduct a thorough audit of current vendors and contracted laboratories, starting with critical suppliers affecting product quality.
  • Review and update the quality management system to integrate vendor qualification as a standard practice.
  • Engage with regulatory experts or consultants if needed to ensure the SOP meets industry and regulatory standards.

Preventive Action

  • Establish a continuous training program focusing on quality management and regulatory compliance for employees involved in vendor management.
  • Implement a periodic review process for the SOP to ensure its relevance and effectiveness over time.
  • Introduce a vendor management system to track and monitor the qualification status and performance of all vendors and contracted laboratories.
  • Promote a culture of quality and compliance within the organization by emphasizing the critical role of vendor qualification in product quality.
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