Unsuitable Drug Product Containers and Closures

Overview

Company:
Stonegate Pharmacy LP
Issued on:
02-Mar-16
Feinumber:
3012038236
Inspection Dates:
23 Feb 2016 to 02 Mar 2016
Location:
2501 W. William Cannon Drive, Ste 203, Austin, TX 78745-5255
Investigators:
  • Margaret M Annes
  • Patty P Kaewussdangkul

Detailed Analysis

Key Observations

  • The significant number of open reports within the (b) (4) database system suggests systemic issues in either the process of managing these reports or in the functionality of the system itself. The lack of a systematic evaluation regarding the potential impact of these open reports on product quality and patient safety is a major compliance risk.

Possible Root Cause :

  • The quality unit has inadequate oversight and prioritization mechanisms to ensure timely resolution of deviations, complaints, change controls, CAPAs, and quality protocols.
  • There might be a lack of resources or training among personnel responsible for managing and resolving issues within the (b) (4) database system.
  • There could be systemic issues in the (b) (4) database system’s functionality or user interface, making it difficult to manage and close reports efficiently.
  • The policies for evaluating the significance of open reports and their potential impact on manufacturing processes and quality control testing may be poorly defined or implemented.

Corrective Action:

  • Conduct a comprehensive review of all open reports within the (b) (4) database system, prioritizing based on potential risk to product quality and patient safety.
  • Implement or enhance training programs for personnel responsible for entering, managing, and resolving reports within the database system to ensure they are competent and can efficiently handle their responsibilities.
  • Evaluate the functionality and user-friendliness of the (b) (4) database system. Consider upgrades or changes to the system if it significantly impedes efficient management of quality-related reports.
  • Revise existing policies or develop new ones to ensure a systematic approach for evaluating the significance of open reports and their potential impacts. This should include clear criteria for prioritization and timelines for resolution.

Preventive Action

  • Introduce regular audit and review cycles for the quality unit to monitor the status of reports within the (b) (4) database system and ensure they are addressed in a timely manner.
  • Implement a system of alerts or reminders for approaching or missed deadlines within the (b) (4) database system.
  • Develop and enforce strict guidelines for entering and managing reports within the database system, including timelines for resolution based on the risk level associated with the report.
  • Establish a training refreshment program for all relevant personnel on the efficient use of the (b) (4) database system, focusing on updates or changes to the system and procedures.
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