There are no regulations or guidelines that prescribe a mandated approach or require segregation of products based on pharmacological activity. There is, however, a lot of interpretation and misunderstanding across the industry.
There is no requirement to use dedicated facilities or even dedicated equipment. The prevailing opinion is to control by risk mitigation on a case-by-case basis.
The current risk-based approach to safety relies on two basic concepts:
- Define a safe level of exposure (for both worker safety and cross-contamination concerns)
- Reduce the potential for exposure through cleaning controls or using dedicated equipment to minimize risk of exposure
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