Page 10 of Attachment B 
All biological safety cabinets undergo scheduled certification to demon- 
strate adequate performance. Autoclaves are also monitored for perfor- 
mance by use of recording charts. Centrifuge equipment received periodic 
maintenance checks to assure aerosol production is contained. Controlled 
access to the P-3 level laboratory is practiced and monitored by the 
laboratory supervisor. The laboratory ventilation systems are equipped 
with alarms that actuate in the event of a system malfunction. 
Work Practices 
No unsafe practices or poor laboratory techniques were noticed during 
this survey. The validation team line operators, supervisors, and the 
Corporate Safety and Health Committee monitor for poor personal hygiene 
habits and work practices. Adherence to safe work practices and company 
rules is required by the company. Maintenance of the fermentation systems 
and in the laboratories is performed only after lock out procedures have 
been implemented and approval granted from the line operators and the 
1 ine supervisor. 
Emergency and Accident Procedures 
Plans for emergencies and laboratory accidents outline specific procedures 
for accidental spills in the laboratories. Corrective action for failure 
of equipment and/or facility safeguards are also included. Plans also exist 
for fire, explosion, and natural disaster. All of these plans are estab- 
lished and well known to those who work in the areas covered by the plans. 
CONCLUSIONS 
Experience has demonstrated that safe conduct of research and production 
processes involving potentially hazardous entities is dependent on good 
work practices, availability and use of effective control technology, 
and effective management. Advancement of recombinant DNA techniques 
into production processes is being undertaken at Eli Lilly in a respon- 
sible manner employing all of Eli Lilly's relevant expertise. 
Evaluations of the product extraction process should be conducted once the 
company has developed the process to the point of utilization. 
RECOMMENDATIONS 
The Pl-LS (2000-liter) production area should be segregated from other 
production operations by structural confinement. Additional containment 
controls could be implemented dependent upon future processes, host organisms, 
recombinant DNA molecules, and product of interest. This will maintain 
the integrity of the process and procedures outlined for recombinant DNA 
fermentation processes. Such system confinement will also enhance the 
containment of the entire operation to preclude accidental exposure to 
other employees and processes. This should be within the interests of 
good manufacturing procedures of the pharmaceutical industry. 
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