Lack of Adequate Design Change Procedures

Overview

Company:
Repro-Med Systems, Inc.
Issued on:
16-Dec-16
Feinumber:
1318360
Inspection Dates:
29 Nov 2016 to 16 Dec 2016
Location:
24 Carpenter Rd, Chester, NY 10918-1057
Investigators:
  • Scott R Izyk

Detailed Analysis

Key Observations

  • The absence of thorough verification and validation activities following design changes suggests a systemic weakness in the firm’s design control and change management processes, underlining the need for immediate corrective and preventive actions.

Possible Root Cause :

  • Lack of comprehensive design control procedures that include considerations for design changes.
  • Failure to recognize the importance of verification and validation activities following design changes.
  • Inadequate change control processes to assess and document the impact of changes on product quality and compliance.
  • Possible gaps in training or awareness regarding the requirements for managing design changes within the quality management system.

Corrective Action:

  • Review and revise the design control and change control procedures to include explicit requirements for verification and validation activities following design changes.
  • Conduct retrospective review and validation of the specific design change referenced in the observation to assess and mitigate any potential impact on product quality.
  • Initiate a training program for relevant personnel on the importance and requirements of design control, change control, and validation activities.

Preventive Action

  • Implement a standardized procedure for managing design changes that includes a risk assessment to understand the impact on product quality and compliance.
  • Enhance the change control system to ensure thorough documentation and review of validation activities for each design change.
  • Regularly audit the design change process to ensure compliance with established procedures and regulatory requirements.
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