Best Quality Practices for Biomedical R&D - Members from an ASQ working group provide analytical methods to enable PAT. - BioPharm International


Best Quality Practices for Biomedical R&D
Members from an ASQ working group provide analytical methods to enable PAT.

BioPharm International
Volume 25, Issue 8, pp. 48-51


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 system

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.

Project management

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.

Figure 2: Quality management system interrelationships.
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).

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