Analytical laboratory quality: Part I. General quality practices.
Once a biotechnology product reaches the final stages of development, the types of quality practices required in the laboratories performing the analytical testing are clearly defined in the applicable regulations. Long before this stage, though, there are innumerable tests and studies conducted in biomolecular facilities that provide critical information upon which product development decisions are made. While sound scientific practices will guide the management of the best of these laboratories, there are several additional operational elements that can significantly enhance the utility of the data to commercial clients. Such laboratory quality practices can also provide considerable benefit to the facility itself, engendering higher confidence in the day-to-day operations within the laboratory. Most of these practices can be simply implemented with pens, notebooks, and diligence.
Ritter
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Quality and Compliance Group, Association of Biomolecular Resource Facilities, Rockville, MD, USA. NRITTER@bioreliance.com
Fowler
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