Receiving, handling, and storage. The handling, storage, and types and quality of materials used in the conduct of biomedical research can affect the outcome
of the research.
Test articles, control articles, and test systems. The purity, concentration, and stability of test articles and control articles (where used) can greatly affect the outcome
and repeatability of a study or an experiment. Therefore, the purity, concentration, and stability and storage of test articles
and control articles shall be specified and evaluated and documented periodically following standard operating procedures.
Legal and ethical considerations. All personnel involved in biomedical research activities are to act in an ethical manner. Examples of non-ethical behavior
include, but are not limited to, plagiarism, fabrication, selective or biased data reporting, and financial or external influencing
of study results.
Protection of IP. An understanding should exist between the parties regarding ownership of IP. In addition, a non-disclosure agreement may
be established to ensure that the confidential nature of the study and study results are maintained.
Vendor selection and qualification
Research institutions may outsource a portion of their research activities to a third party. The subcontracted work may be
subject to the research institution's quality system. As such, care must be taken to place such work with a competent subcontractor.
The research institution shall have a policy and procedure(s) for the selection and purchasing of services and supplies it
uses that affect the quality of its research work.
A. Mark Trotter is president of Trotter Biotech Solutions, Inc. and is a section board member of the American Society for Quality's Food,
Drug, and Cosmetics division, firstname.lastname@example.org
. Rick Calabrese is global corporate director of Quality Systems at Sartorius Stedim Biotech and is a senior member of ASQ's FD&C division.
Ulo Palm, MD, PhD, is senior vice-president of Clinical Operations and Biometrics at Forest Research Institute and is a senior member of ASQ's
FD&C division. Alice Krumenaker is manager R&D QA at CorePharma and is a senior member of ASQ's FD&C division.
1. PhRMA, Pharmaceutical Industry Profile 2011, Washington, DC: PhRMA (April 2011).
2. National Center for Dissemination of Disability Research, "What Are the Standards for Quality Research?" Quality Matters 4 (2011).
3. H. Moses III et al., JAMA, 9 (2005).
4. National Center for Dissemination of Disability Research, Quality Matters, 4 (2011).
5. R. Calabrese and U. Palm, Quality Digest (2008).
6. ASQ, Technical Report, ASQ TR1-2012, Best Quality Practices for Biomedical Research in Drug Development, FD&C Division
7. WHO, World Health Organization, Handbook: Quality Practices for Biomedical Research (2006).
8. ISO 17025, ISO 900X.
9. BARQA, Guidelines for Quality in Non-Regulated Scientific Research, BARQA (2008).
10. ICH, Q2 Validation of Analytical Procedures: Text and Methodology, 1994/1996.
11. 21 CFR Part 58.
12. ICH, Q9 Quality Risk Management.