SUMMARY OF TECHNICAL REPORT CONTENT
The FD&C Division of ASQ has published a technical report addressing the need for biomedical research standards (6). The ASQ
guideline specifies the general quality requirements for non-regulated biomedical research in drug development to ensure credibility
of biomedical research results. This includes both large- and small-molecule discovery and non-clinical development that is
not covered by GXP (6-11).
The target audience for this report is the scientific staff at institutions and companies involved in drug development. Compliance
with applicable regulatory and safety requirements is not covered by this report. The following summarizes the major sections
covered in detail in the technical report.
Management of the research institution shall establish and document policies and procedures for its activities. Management
shall ensure appropriate organizational structures, resources, and processes to implement, maintain, and continuously improve
the quality system.
The research institution shall have necessary authority and resources to perform duties and responsibilities; policies restraining
external influences; protection of intellectual property; accountability of data and reports; effective, independent quality
management systems; and proper facilities and equipment to perform study.
The research program should follow good management practices and have a well-defined work structure, track and communicate
reporting progress and performance, and have change control for study objectives and outcomes.
Quality management system. Management shall establish, implement, and maintain a quality management system (QMS) appropriate to the scope of its activities.
The QMS established must be capable of ensuring reproducibility of biomedical research results to support effective drug development
(e.g., deviation management, self-inspections [audits], research review, internal review, external reviews) (see Figure 2).
Figure 2: Quality management system interrelationships.