Lack of Written Guidelines and Full Compliance

Overview

Company:
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Issued on:
14-Aug-14
Feinumber:
1972829
Inspection Dates:
04 Aug 2014 to 14 Aug 2014
Location:
SSM Health Care St. Louis DBA SSM St. Clare Health Center, 1015 Bowles Avenue, Fenton, MO 63026
Investigators:
  • Shirley J Berryman

Detailed Analysis

Key Observations

  • The absence of written procedures and compliance with core processes like quality reviews, change control, sample collection, and batch release can significantly impact product quality and regulatory compliance.

Possible Root Cause :

  • Lack of standardized operational procedures resulting in procedural inconsistencies.
  • Inadequate training or oversight, leading staff to not follow or record required processes correctly.
  • Insufficient regulatory knowledge or oversight, resulting in failure to implement necessary quality control and documentation practices.

Corrective Action:

  • Develop and implement written procedures for periodic quality reviews, change control, reserve sample collection, and batch release processes.
  • Conduct training sessions for all relevant personnel on these newly implemented procedures to ensure understanding and compliance.
  • Establish a routine audit schedule to verify adherence to these procedures and identify areas for continuous improvement.

Preventive Action

  • Implement a quality management system software to automate and track compliance with these procedures.
  • Regularly review and update procedures to reflect best practices and regulatory changes.
  • Enhance staff training programs to include in-depth discussions on the importance of documentation and compliance in pharmaceutical manufacturing.
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