Missing Stability Data in Expiration Determination


Reliable Rexall-A Compounding Pharmacy
Issued on:
Inspection Dates:
18 Mar 2016 to 29 Mar 2016
801 Irving St, San Francisco, CA 94122-2310
  • Lucila B Nwatu
  • Kristin M Abaonza

Detailed Analysis

Key Observations

  • Critical insights include the identification of a systemic failure in laboratory analysis, quality control processes, supplier management, and documentation practices. The observation highlights the need for a holistic approach to address and prevent similar issues in the future.

Possible Root Cause :

  • Inadequate testing methodology or equipment calibration leading to inaccurate results.
  • Insufficient quality control checks at different stages of production.
  • Poor supplier quality management for ingredients used in the product formulation.
  • Lack of a robust change control system to address and document discrepancies.
  • Failure to properly execute and document investigations into out-of-specification results.

Corrective Action:

  • Conduct re-testing of the hormone sample using properly calibrated equipment and validated methods.
  • Review and reinforce the supplier qualification process to ensure all ingredients meet specified quality standards.
  • Implement additional quality control checkpoints throughout the production process to identify and correct discrepancies promptly.
  • Develop and implement a change control procedure that includes thorough investigation and documentation of all changes and discrepancies.
  • Train or re-train personnel involved in quality control, documentation, and product release decisions on the importance of adherence to procedures and regulatory requirements.

Preventive Action

  • Establish a schedule for routine equipment calibration and maintenance to prevent future discrepancies in test results.
  • Enhance the supplier auditing process to ensure continuous compliance with quality requirements.
  • Implement a quality risk management system to proactively identify and mitigate potential quality issues.
  • Develop a standardized approach for conducting investigations into out-of-specification results, including root cause analysis and implementation of corrective and preventive actions.
  • Regularly review and update quality-related procedures and training materials to reflect current best practices and regulatory expectations.
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