Independent Quality Assurance Units (QAUs)
Outsourcing of the Quality Assurance Unit (QAU) Function
Case Study 1
This analytical laboratory is a unit of an S&P 500 industrial manufacturer. Management prefers to outsource select operations and contracted Quality Assurance Consultancy to operate as the laboratory QAU, operating under the U.S. Environmental Protection Agency (EPA) good laboratory practices (GLP), American Industrial Hygiene Association (AIHA) and other state and federal requirements. A total of three full-time Quality Assurance Consultancy experts operated as the QAU, with additional personnel traveling as needed. We performed the following duties:
Quality Assurance Consultancy is now leading the accreditation process of the laboratory to gain ISO 17025 for testing laboratories status. 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.
- Maintained the master schedule of in-house studies
- Maintained a QAU file of all studies, with a copy of the protocol and of all audit reports
- Reviewed all protocols before approval. Performed all in-phase inspections, data audits and report audits for all studies performed by the laboratory while issuing the QAU statements
- Assures distribution of audit reports to study directors and testing facility management, when appropriate
- Performed facility inspections of contract research organizations’ (CROs’) facilities for compliance with GLP, AIHA and other specified regulations
- Maintained all personnel training files
- Upgraded all standard operating procedures (SOPs) in the quality system for full compliance with the GLPs, AIHA and others
- Maintained the electronic database from which all electronic SOPs were accessible
- Advised laboratory personnel in improving data collection forms, substances, reagents and solution databases, report presentation, etc.
- Performed specialized GLP training of laboratory personnel.
- And much more
Case Study 2
Another pharmaceutical venture-capital company was starting Phase I clinical studies. It needed an in-house QAU but did not expect to be able to keep a person occupied full time. It also needed GLP expertise to assure that all quality systems implemented were compliant with the GLPs, and that clinical studies contracted to CROs complied with the GCPs.
Quality Assurance Consultancy experts were on-site three days per week, but only if the client needed them which assured the functions of the QAU were performed correctly. We:
- Revised the entire SOP manual and expanded the QAU SOPs while adding archiving SOPs. Upgraded all equipment SOPs to abide by the GLP requirements. Reviewed and revised other SOPs as needed. Improved data collection forms. Maintained all historical SOPs and distributed copies of new SOPs.
- Maintained the QAU study files, including a copy of the protocol, a master inspection log for each study and all inspection reports.
- Conducted protocol reviews, in-phase inspections, data and report audits for all studies performed by the laboratory. Signed the QAU statement in study reports.
- Assured distribution of audit reports to study directors and testing facility management, when appropriate.
- Maintained all personnel training files.
- Reviewed equipment qualification data; advised on appropriate design of qualification testing.
- Advised management and scientists on improvements needed to the quality system.
- Established archives for study data and trained the designated archivist.
- Performed facility inspections of CRO facilities for compliance with the GLPs or good clinical practice (GCP), as applicable.