Independent Quality Assurance Units Case Studies

Outsourcing of the QAU Function

This analytical laboratory is a captive unit of a S&P 500 industrial manufacturer. Management prefers to outsource select operations, and contracted QAI to operate as the laboratory QAU, operating under EPA GLP, AIHA, and other state and federal requirements. A total of three full-time QAI employees operate as the QAU, with additional personnel traveling from other QAI offices as needed. QAI performs the following duties:

  • Maintain the master schedule of in-house studies.
  • Maintain a QAU file of all studies, with a copy of the protocol and of all audit reports.
  • Review all protocols before approval. Perform all in-phase inspections, data audits, and report audits for all studies performed by the laboratory. Issue the QAU statements.
  • Assure distribution of audit reports to study directors and testing facility management, when appropriate.
  • Perform facility inspections of CRO facilities for compliance with GLP, AIHA, and other specified regulations.
  • Maintain all personnel training files.
  • Upgrade all SOPs in the Quality System for full compliance with the GLPs, AIHA, and others.
  • Maintain the electronic database from which all electronic SOPs are accessible.
  • Advise laboratory personnel in improving data collection forms, substances, reagents, and solution databases, report presentation, etc.
  • Perform specialized GLP training of laboratory personnel.
  • And much more

Recent initiative – QAI is leading the accreditation process of the laboratory to ISO 17025 for testing laboratories. This has involved upgrades of all SOPs for compliance with the requirements of ISO 17025, organizing specialized training sessions, acting as liaison with A2LA, etc.

Company Too Small for Full-Time QAU

This pharmaceutical venture-capital company is starting Phase I clinical studies. It needs an in-house Quality Assurance Unit, but does not expect to be able to keep a person occupied full time. It also needs GLP expertise to assure that all Quality Systems implemented are compliant with the GLPs, and that clinical studies contracted to CROs comply with the GCPs. QAI is generally on-site at this company three days per week, but only as long as needed to assure the functions of the QAU. These include:

  • Revise the entire SOP manual. Expand the QAU SOPs and add archiving SOPs. Upgrade all equipment SOPs to abide by the GLP requirements. Review and revise other SOPs as needed. Improve data collection forms. Maintain all historical SOPs and distribute copies of new SOPs.
  • Maintain the QAU study files, including a copy of the protocol, a master inspection log for each study, and all inspection reports.
  • Conduct protocol reviews, in-phase inspections, data and report audits for all studies performed by the laboratory. Signs the QAU statement in study reports.
  • Assure distribution of audit reports to study directors and testing facility management, when appropriate.
  • Maintain all personnel training files.
  • Review equipment qualification data; advise on appropriate design of qualification testing.
  • Advise management and scientists on improvements needed to the Quality System.
  • Establish archive for study data. Train the designated archivist.
  • Perform facility inspections of CRO facilities for compliance with the GLPs or GCPs, as applicable.