the transition from bench scale experiments to pilot plant 
operations. As part of that transition the industry has put into 
effect numerous practices which reflect our concern with safety 
of workers and the environment. Examples of industry practices 
among our members include: 
a. Use of physical and biological containment based 
on the NIH Guidelines; 
b. Sterilization of wastes prior to disposal; 
c. Challenge and validation of safety procedures; 
d. Use of accounting systems for biologically active 
products consistent with Good Laboratory Practices 
/ 
and Good Manufacturing Practices; 
e. Health monitoring programs; and 
f. Careful design of procedures and equipment to 
minimize the possibility and effects of human 
error , 
These are but a few of the areas in which we have 
instituted special controls. Many of these practices result from 
the regulations of the various agencies to which our industry is 
already subject. Others result from compliance with the NIH 
Guidelines and from our concern for worker and environmental 
safety. Finally, certain practices result from the knowledge we 
have gained from extensive experience in the fermentation of 
antibiotics and other biochemicals. These fermentations are very 
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