Support of Existing Quality Assurance Units

QAI provides long-term or temporary help to established Quality Assurance Units to meet submission deadlines. QAI can operate as part of the existing QAU for one or more of the following audits and inspections:

• Pre-placement GLP evaluations of potential contractor facilities
• Pre-placement GCP evaluations of potential CRO facilities and IRB
• Protocol evaluations
• In-process inspections of laboratory and field studies
• Study raw data audits
• Final report reviews

Expertise includes inspections and audits of:

• Toxicological studies, including acute, sub-chronic, chronic, teratology, multi-generational, as well as ADME, and TK studies
• Clinical studies, including pharmacokinetics
• Environmental fate studies, including degradation and metabolism, as well as field dissipation and ground water
• Residue studies, including plant metabolism, magnitude of the residue, rotational and method validation
• Plant-pesticide and plant-made pharmaceutical studies, including characterization and expression

_Case Study

Act as the Independent Quality Assurance Unit

QAI operates as the entire QAU for a number of companies, conducting all duties required by the GLPs:

• Maintain a copy of the master schedule
• Maintain copies of all study protocols for GLP studies
• Conduct GLP training of current and new study personnel
• Conduct facility inspections, both internally and at contractor facilities
• Review all protocols before study initiation
• Conduct inspections of all studies during one or more phases
• Audit the study data
• Review the study report
• Report all findings from audits and inspections to the study director and management
• Sign the QA statement in the final report
• Maintain a QA study file for each study, with a copy of the protocol, amendments, and deviations, and a QA inspection log
• Maintain the SOPs that describe responsibilities and procedures of the QAU
• Assist client during FDA or EPA GLP inspection

QAI offers these services to the following companies:

• Facilities too small or too new to justify a full-time QAU
• Industry Task Forces that require an outside independent QAU
• Companies that prefer to outsource the QAU function