ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Good Large Scale Practice (GLSP)

The National Institutes of Health (NIH) specifies physical containment levels and defines Biosafety Levels for Large Scale in their “Guidelines for Research Involving Recombinant DNA Molecules” (NIH Guidelines) – Appendix K – “Physical Containment for Large Scale Uses of Organisms Containing Recombinant DNA Molecules”. April 2002.

Level of physical containment recommended for large-scale (more than 10 liters of culture) research or production involving viable, non-pathogenic, and non-toxigenic recombinant strains derived from host organisms that have an extended history of safe large scale use. Likewise, the GLSP level of physical containment is recommended for organisms that have a built-in environmental limitation that permits optimum growth in large-scale bioreactors, but limited survival if released to the environment.

1. BL1-LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL1 containment at the laboratory scale and that do not qualify for GLSP.

2. BL2–LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL2 containment at the laboratory scale.

3. BL3–LS (Large Scale): Practices, safety equipment, and facilities appropriate for work performed with large scale (more than 10 liters) research or production of viable organisms containing recombinant DNA molecules that require BL3 containment at the laboratory scale.

Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities

Publication Date: 2004

See also: Biosafety Level NIH Guidelines

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