Management issues, human impact

The protection of ground and surface water has major environmental priority because any contamination may cause a risk for its use in human and animal nutrition and may disturb aquatic biocoenosis. The OECD-indicator list (OECD 1997) subsummarises state and risk assessment approaches under this issue. We will confine our efforts to indicators that are appropriate to evaluate the impact of different farm management practices. 

The answers to these questions drive the next issue—of when to switch vendors. The needs of the project may drive the sponsor to run one or more parallel programs with other vendors one campaign to produce materials for first time in human studies, another to produce phase II clinical trail supplies materials, and a third to determine the impact of the different campaigns on the clinical program. Now what started as one sponsor-vendor relationship for one project has turned into three. Multiply this by the number of projects your company is managing at any given time and you will begin to understand the extent of the impact of such a decision. 

FDA provides a website with public information on this issue, " as well as specific guidance for industry. " " " These documents describe a process for deciding if a proposed antimicrobial use in food animals would likely lead to resistance that would negatively impact human health. It outlines possible methods for ranking antimicrobials based on their importance for human use conducting a qualitative risk assessment for a proposed animal antimicrobial use and managing risks identified in the assessment. 

Effective management of an industrial operation requires detailed process knowledge of each individual plant to understand its potential, as well as having a clear understanding of the entire operation so that cross impacts are well understood. In addition to process knowledge, it is important to imderstand the marketing issues for each product, environmental issues, human dynamics, as well as numerous other business factors. 

---