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Internal Quality Auditing

internal-audity.pngAn internal quality audit, as it applies to the medical device / pharmaceutical / biologic industries, is a planned, independent, and documented assessment of cGMP related activities and documents to determine whether these activities comply with all internal policies and procedures as well as comply with all applicable government requirements.

The goal of the audit program is to identify, through examination and written evaluation, that quality system(s) have been implemented, maintained, and remain effective. At a high level, internal quality auditing is intended to bring a systematic, disciplined approach to evaluate and improve the organization’s position, thus demonstrating a due diligence to regulatory body agencies to strive for continuous improvement. With commitment to integrity and accountability, internal auditing provides value to governing bodies and senior management as an objective source of independent advice.

The audit program should establish the general requirements with regards to scope, frequency, and documentation of audits, and therefore should be an established process of its own.

The following is a list of activities that may be audited:

  • Batch Records
  • Facility appearance and maintenance
  • Safety Issues
  • Training requirements / records
  • Flow for Man, Materials, Machines
  • Log Books
  • Sample Handling
  • Equipment Calibrations
  • Environmental Monitoring
  • Storage, Segregation and Labeling
  • Cleaning
  • SRN Reviews
  • Gowning
  • Time Out of Refrigeration
  • Equipment

Internal auditing frequently involves measuring compliance with the entity's policies and procedures. However, internal auditors are not responsible for the execution of the organization’s activities; they advise the Quality Unit and area being audited on how to better execute their responsibilities. Internal quality audits should be performed in a professional manner meant to mimic what regulatory inspector(s) would look for, and therefore attempts to avoid official regulatory observations / warning letters / consent decrees / etc.

Ultimately, internal quality audits are an important part of an organization’s quality management system and are a regulation requirement, both FDA and E.U. Please note these internal findings are not subject to regulatory inspection but the process, and adherence and dedication to performing them are.

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